299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
臨床試験数 : 1,695 / 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2019-003501-10-NO (EUCTR) | 08/03/2021 | 29/05/2020 | Use of repeated Multiple Breath Washout to detect and treat pulmonary exacerbation in children with Cystic Fibrosis, a phase 4 multicenter randomized controlled study. | Use of repeated Multiple Breath Washout to detect and treat pulmonary exacerbation in children with Cystic Fibrosis, a phase 4 multicenter randomized controlled study. - MBWtodetectPEXinCF | Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Amoxicillin Product Name: Amoxicillin INN or Proposed INN: AMOXICILLIN Trade Name: Amoxicillin and Clavulanic acid Product Name: Augmentin INN or Proposed INN: AMOXICILLIN INN or Proposed INN: CLAVULANIC ACID Trade Name: Heracillin Product Name: Heracillin INN or Proposed INN: FLUCLOXACILLIN Trade Name: Dicloxacillin Product Name: Dicloxacillin INN or Proposed INN: DICLOXACILLIN Trade Name: Trimethoprim and Sulfamethoxazole Product Name: Bactrim INN or Proposed INN: Trimetoprim Other descriptive name: TRIMETHOPRIM INN or Proposed INN: SULFAMETHOXAZOLE Trade Name: Clarithromycin Product Name: Klacid INN or Proposed INN: Klacid Other descriptive name: CLARITHROMYCIN Trade Name: Rifampicin Product Name: Rimactan INN or Proposed INN: RIFAMPICIN Trade Name: Doxycycline Product Name: Doxycyclin INN or Proposed INN: DOXYCYCLINE Product Name: Fucidin Tablets INN or Proposed INN: Fusidin Other descriptive name: FUSIDIC ACID Trade Name: Ciprofloxacin Product Name: Ciprofloxacin INN or Proposed INN: Ciproxin Other descriptive name: CIPROFLOXACIN Trade Name: Linez | Vãstre Gõtalandsregionen, Sweden | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Denmark;Norway;Sweden | ||
| 2 | EUCTR2019-003501-10-DK (EUCTR) | 22/01/2021 | 22/04/2020 | Use of repeated Multiple Breath Washout to detect and treat pulmonary exacerbation in children with Cystic Fibrosis, a multicenter randomized controlled study. | Use of repeated Multiple Breath Washout to detect and treat pulmonary exacerbation in children with Cystic Fibrosis, a multicenter randomized controlled study. - MBWtodetectPEXinCF | Cystic fibrosis MedDRA version: 22.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | INN or Proposed INN: AMOXICILLIN INN or Proposed INN: CLAVULANIC ACID INN or Proposed INN: AMOXICILLIN INN or Proposed INN: FLUCLOXACILLIN INN or Proposed INN: DICLOXACILLIN INN or Proposed INN: SULFAMETHOXAZOLE INN or Proposed INN: Trimetoprim Other descriptive name: TRIMETHOPRIM INN or Proposed INN: Clarithromycin Other descriptive name: CLARITHROMYCIN INN or Proposed INN: RIFAMPICIN INN or Proposed INN: DOXYCYCLINE INN or Proposed INN: Fusidic acid Other descriptive name: FUSIDIC ACID INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN INN or Proposed INN: Linezolid Other descriptive name: LINEZOLID INN or Proposed INN: CLINDAMYCIN Other descriptive name: CLINDAMYCIN INN or Proposed INN: Cefuroxim Other descriptive name: CEFUROXIME INN or Proposed INN: CEFALEXIN | Västra Götalandsregionen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Denmark;Norway;Sweden | ||
| 3 | EUCTR2019-003501-10-SE (EUCTR) | 08/04/2020 | 07/04/2020 | Use of repeated Multiple Breath Washout to detect and treat pulmonary exacerbation in children with Cystic Fibrosis, a multicenter randomized controlled study. | Use of repeated Multiple Breath Washout to detect and treat pulmonary exacerbation in children with Cystic Fibrosis, a multicenter randomized controlled study. - MBWtodetectPEXinCF | Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | INN or Proposed INN: AMOXICILLIN INN or Proposed INN: CLAVULANIC ACID INN or Proposed INN: AMOXICILLIN INN or Proposed INN: FLUCLOXACILLIN INN or Proposed INN: DICLOXACILLIN INN or Proposed INN: SULFAMETHOXAZOLE INN or Proposed INN: Trimetoprim Other descriptive name: TRIMETHOPRIM INN or Proposed INN: Clarithromycin Other descriptive name: CLARITHROMYCIN INN or Proposed INN: RIFAMPICIN INN or Proposed INN: DOXYCYCLINE INN or Proposed INN: Fusidic acid Other descriptive name: FUSIDIC ACID INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN INN or Proposed INN: Linezolid Other descriptive name: LINEZOLID INN or Proposed INN: CLINDAMYCIN Other descriptive name: CLINDAMYCIN INN or Proposed INN: Cefuroxim Other descriptive name: CEFUROXIME INN or Proposed INN: CEFALEXIN | Västra Götalandsregionen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Denmark;Norway;Sweden | ||
| 4 | EUCTR2015-003399-58-DK (EUCTR) | 14/01/2017 | 07/01/2016 | Can antibiotic treatment improve the prognosis of Pseudomonas aeruginosa infected patients with chronic pulmonary obstructive disease, non-cystic fibrosis bronchiectasis and asthma? | Target-ABC (Targeted AntiBiotics for Chronic pulmonary disease):Can targeted antibiotic therapy improve the prognosis of Pseudomonas aeruginosa infected patients with chronic pulmonary obstructive disease, non-cystic fibrosis bronchiectasis and asthma? - Target-ABC (Targetted AntiBiotics for Chronic pulmonary disease) | Respiratory tract infection Bacterial infection with Pseudomonas aeruginosaChronic obstructive pulmonary disease (COPD)Non-cystic fibrosis bronchiectasisAsthma MedDRA version: 20.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Ciprofloxacin INN or Proposed INN: ciprofloxacin hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE Product Name: Piperacillin/Tazobactam INN or Proposed INN: piperacillin sodium , tazobactam sodium Other descriptive name: PIPERACILLIN SODIUM | COP:TRIN Region Hovedstaden (Gentofte hospital) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | Denmark | ||
| 5 | EUCTR2009-012575-10-SE (EUCTR) | 08/12/2016 | 04/10/2016 | Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis - TORPEDO-CF | Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis - TORPEDO-CF | Product Name: Ceftazidime INN or Proposed INN: Ceftazidime Other descriptive name: N/A Product Name: Tobramycin INN or Proposed INN: Tobramycin Other descriptive name: N/A Product Name: Ciprofloxacin INN or Proposed INN: Ciprofloxacin Other descriptive name: N/A Product Name: Ciprofloxacin INN or Proposed INN: Ciprofloxacin Other descriptive name: N/A | University Hospitals Bristol NHS Foundation Trust | University of Liverpool | Not Recruiting | Female: yes Male: yes | 260 | Phase 4 | United Kingdom;Sweden | |||
| 6 | EUCTR2016-001785-29-IE (EUCTR) | 15/08/2016 | 10/05/2016 | Study of the effects of combined treatment with the CFTR corrector ivacaftor and IV antibiotics on infection in CF. | Combined Effect of CFTR Modifiers and Intensive Antibiotic Treatment | Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Kalydeco INN or Proposed INN: IVACAFTOR Trade Name: Ciprofloxacin INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE Product Name: Flucloxicillin INN or Proposed INN: FLUCLOXACILLIN SODIUM Trade Name: Fortum INN or Proposed INN: CEFTAZIDIME Product Name: Tobramycin INN or Proposed INN: TOBRAMYCIN SULFATE Trade Name: Meropenem INN or Proposed INN: Meropenem Other descriptive name: MEROPENEM Trade Name: Colistin INN or Proposed INN: COLISTIMETHATE SODIUM | St. Vincent's University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Ireland | |||
| 7 | NCT02555059 (ClinicalTrials.gov) | July 15, 2016 | 18/9/2015 | Special Drug Use Investigation of Ciproxan Injection in Pediatrics | Special Drug Use Investigation of Ciproxan® Injection in Pediatrics | Cystitis / Pyelonephritis / Cystic Fibrosis / Anthrax | Drug: Cipro (Ciprofloxacin, BAYQ3939) | Bayer | NULL | Completed | N/A | 14 Years | All | 48 | Japan | |
| 8 | NCT02661438 (ClinicalTrials.gov) | January 12, 2016 | 30/12/2015 | Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo | Multicenter Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation in Subjects With Non-Cystic Fibrosis Bronchiectasis (NCFB) or Chronic Obstructive Pulmonary Disease (COPD) Using Matching Placebo | Bronchiectasis;Pulmonary Disease, Chronic Obstructive | Drug: Placebo to Ciprofloxacin DPI (BAYQ3939) | Bayer | Novartis | Completed | 40 Years | N/A | All | 46 | N/A | United States |
| 9 | EUCTR2013-005366-19-FR (EUCTR) | 19/05/2015 | 22/06/2015 | A Multi-centre, Randomised, Double-Blind, Placebo-Controlled Study to evaulate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Coprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to the non-cystic fibrosis bronchiectasis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4) | Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Australia;Germany;Netherlands;New Zealand | ||
| 10 | EUCTR2013-005366-19-PL (EUCTR) | 11/02/2015 | 26/11/2014 | A Multi-centre, Randomised, Double-Blind, Placebo-Controlled Study to evaulate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Coprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to the non-cystic fibrosis bronchiectasis. The study includes a 28-day open-label extension (all patients will receive study drug for the last 28 days of the study). | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4) | Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 19.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | Serbia;United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Georgia;Germany;New Zealand | ||
| 11 | EUCTR2013-005348-28-PL (EUCTR) | 11/02/2015 | 26/11/2014 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis. This study includes a 28-day open label extension (all patients will receive study drug for the last 28 days of the study). | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) | Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis. MedDRA version: 19.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 19.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;South Africa;Latvia;Germany | ||
| 12 | EUCTR2013-004659-19-SK (EUCTR) | 15/12/2014 | 06/10/2014 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 | non-CF bronchiectasis MedDRA version: 20.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer Healthcare AG, D-51368 Leverkusen, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Slovakia;Thailand;Russian Federation;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 13 | EUCTR2011-004208-39-SK (EUCTR) | 18/11/2014 | 21/10/2014 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 | bronchiectasis MedDRA version: 18.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Australia;Denmark;Germany;Latvia;New Zealand;Japan | ||
| 14 | EUCTR2011-004208-39-LV (EUCTR) | 11/11/2014 | 26/09/2014 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 | bronchiectasis MedDRA version: 17.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 400 | Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Australia;Denmark;Latvia;Germany;New Zealand;Japan | |||
| 15 | EUCTR2013-004659-19-LV (EUCTR) | 11/11/2014 | 30/09/2014 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 | non-CF bronchiectasis MedDRA version: 17.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer Healthcare AG, D-51368 Leverkusen, Germany | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 16 | EUCTR2013-005348-28-IE (EUCTR) | 07/11/2014 | 11/09/2014 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis. This study includes a 28-day open-label extension (all patients will receive study drug for the last 28 days of the study). | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) | Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis. MedDRA version: 19.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 19.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;South Africa;Germany;Latvia | ||
| 17 | EUCTR2013-004659-19-BG (EUCTR) | 26/09/2014 | 05/08/2014 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 | non-CF bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 18 | EUCTR2013-004659-19-PT (EUCTR) | 02/09/2014 | 03/07/2014 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 | non-CF bronchiectasis MedDRA version: 19.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer Healthcare AG, D-51368 Leverkusen, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | United States;Portugal;Taiwan;Hong Kong;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;New Zealand | ||
| 19 | EUCTR2013-004659-19-CZ (EUCTR) | 27/08/2014 | 20/05/2014 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 | non-CF bronchiectasis MedDRA version: 20.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | United States;Portugal;Taiwan;Hong Kong;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;New Zealand | ||
| 20 | EUCTR2013-005366-19-RO (EUCTR) | 30/07/2014 | 30/05/2014 | A Multi-centre, Randomised, Double-Blind, Placebo-Controlled Study to evaulate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Coprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to the non-cystic fibrosis bronchiectasis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4) | Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis MedDRA version: 17.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 17.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Georgia;South Africa;Germany;Latvia;Netherlands;New Zealand | ||
| 21 | EUCTR2013-005348-28-RO (EUCTR) | 30/07/2014 | 30/05/2014 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) | Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis. MedDRA version: 17.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 17.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Italy;Hungary;Canada;Poland;Romania;Australia;Georgia;South Africa;Germany;Latvia;Netherlands;New Zealand | ||
| 22 | EUCTR2013-005348-28-LV (EUCTR) | 28/07/2014 | 08/05/2014 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis. This study includes a 28-day open-label extension (all patients will receive study drug for the last 28 days of the study). | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) | Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis. MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;South Africa;Latvia;Germany;New Zealand | ||
| 23 | EUCTR2013-005366-19-ES (EUCTR) | 17/06/2014 | 11/04/2014 | A multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Pulmaquin®(ARD-3150, dual reléase ciprofloxacin for inhalation)in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with non-cystic fibrosis bronchiectasis (ORBIT 4) | Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis MedDRA version: 16.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 100000004862 MedDRA version: 16.1;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: ciprofloxacin hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Australia;Netherlands;Germany;New Zealand | ||
| 24 | EUCTR2013-004659-19-AT (EUCTR) | 17/06/2014 | 13/05/2014 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 | non-CF bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 25 | EUCTR2013-005348-28-ES (EUCTR) | 16/06/2014 | 11/04/2014 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) | Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis. MedDRA version: 17.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 17.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Italy;Hungary;Canada;Poland;Romania;Australia;Latvia;Germany;Netherlands;New Zealand | ||
| 26 | NCT02104245 (ClinicalTrials.gov) | May 28, 2014 | 28/3/2014 | Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension | Non Cystic Fibrosis Bronchiectasis | Drug: Ciprofloxacin dispersion for inhalation;Drug: Placebo | Aradigm Corporation | Grifols Therapeutics LLC | Completed | 18 Years | N/A | All | 304 | Phase 3 | United States;Australia;Canada;Former Serbia and Montenegro;France;Georgia;Hungary;Israel;Italy;Korea, Republic of;New Zealand;Peru;Poland;Romania;Spain;United Kingdom;Germany |
| 27 | EUCTR2013-005366-19-IT (EUCTR) | 22/05/2014 | 27/03/2014 | A Multi-centre, Randomised, Double-Blind, Placebo-Controlled Study to evaulate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Coprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to the non-cystic fibrosis bronchiectasis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4) | Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis MedDRA version: 16.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 100000004862 MedDRA version: 16.1;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Australia;Netherlands;Germany;New Zealand | ||
| 28 | EUCTR2013-005348-28-IT (EUCTR) | 22/05/2014 | 24/03/2014 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) | Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis. MedDRA version: 16.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 100000004862 MedDRA version: 16.1;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Ireland;Israel;Italy;United Kingdom;Hungary;Canada;Poland;Romania;Australia;Latvia;Netherlands;Germany;New Zealand | ||
| 29 | EUCTR2013-004659-19-LT (EUCTR) | 12/05/2014 | 20/03/2014 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 | non-CF bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | Serbia;Portugal;United States;Hong Kong;Taiwan;Slovakia;Thailand;Lithuania;Turkey;Austria;Russian Federation;Czech Republic;Argentina;Poland;Brazil;Romania;Australia;South Africa;Bulgaria;Netherlands;Latvia;Germany;China;Korea, Republic of | ||
| 30 | EUCTR2013-005366-19-HU (EUCTR) | 08/05/2014 | 21/03/2014 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) | Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis. MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Serbia;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Georgia;Germany;New Zealand | ||
| 31 | EUCTR2013-005348-28-HU (EUCTR) | 06/05/2014 | 21/03/2014 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) | Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis. MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;South Africa;Germany;Latvia | ||
| 32 | EUCTR2013-005348-28-GB (EUCTR) | 06/05/2014 | 12/03/2014 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis. This study includes a 28-day open-label extension (all patients will receive study drug for the last 28 days of the study). | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) | Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis. MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Italy;Hungary;Canada;Poland;Romania;Australia;South Africa;Germany;Latvia | ||
| 33 | NCT02106832 (ClinicalTrials.gov) | April 30, 2014 | 4/4/2014 | Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE) | Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis. | Bronchiectasis | Drug: Ciprofloxacin (BAYQ3939) dry powder for inhalation;Drug: Placebo | Bayer | Novartis | Completed | 18 Years | N/A | All | 521 | Phase 3 | United States;Argentina;Australia;Austria;Brazil;Bulgaria;China;Czechia;Germany;Hong Kong;Korea, Republic of;Latvia;Lithuania;Netherlands;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Taiwan;Thailand;Turkey;Czech Republic |
| 34 | EUCTR2013-005366-19-GB (EUCTR) | 29/04/2014 | 17/03/2014 | A Multi-centre, Randomised, Double-Blind, Placebo-Controlled Study to evaulate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Coprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to the non-cystic fibrosis bronchiectasis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections withPseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4) | Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis MedDRA version: 16.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 100000004862 MedDRA version: 16.1;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Netherlands;Germany;New Zealand | ||
| 35 | EUCTR2013-004659-19-DE (EUCTR) | 23/04/2014 | 03/02/2014 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 | non-CF bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | Serbia;United States;Portugal;Philippines;Taiwan;Hong Kong;Slovakia;Thailand;Russian Federation;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Argentina;Brazil;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 36 | EUCTR2013-004659-19-NL (EUCTR) | 23/04/2014 | 27/02/2014 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 | non-CF bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Slovakia;Thailand;Russian Federation;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 37 | NCT01515007 (ClinicalTrials.gov) | March 31, 2014 | 10/1/2012 | Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Subjects With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) | Non Cystic Fibrosis Bronchiectasis | Drug: Ciprofloxacin dispersion for inhalation;Drug: Placebo | Aradigm Corporation | Grifols Therapeutics LLC | Completed | 18 Years | N/A | All | 278 | Phase 3 | United States;Australia;Canada;Germany;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Poland;Romania;South Africa;Spain;Taiwan;United Kingdom;New Zealand |
| 38 | NCT02015507 (ClinicalTrials.gov) | January 2014 | 9/12/2013 | An Open-Label, Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Multiple-Dose Ciprofloxacin on Ivacaftor and VX-661 in Combination With Ivacaftor | An Open-Label, Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Multiple-Dose Ciprofloxacin on the Multiple-Dose Pharmacokinetics of Ivacaftor and on the Multiple-Dose Pharmacokinetics of VX-661 Administered in Combination With Ivacaftor | Cystic Fibrosis | Drug: ivacaftor;Drug: VX-661;Drug: ciprofloxacin | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | 55 Years | Both | 34 | Phase 1 | NULL |
| 39 | EUCTR2011-004208-39-GB (EUCTR) | 30/05/2013 | 11/12/2012 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 | bronchiectasis MedDRA version: 18.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan | ||
| 40 | NCT01764841 (ClinicalTrials.gov) | May 2, 2013 | 8/1/2013 | Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE) | Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis. | Bronchiectasis | Drug: Ciprofloxacin DPI (BAYQ3939);Drug: Placebo | Bayer | Novartis | Completed | 18 Years | N/A | All | 416 | Phase 3 | United States;Argentina;Australia;Denmark;France;Germany;Israel;Italy;Japan;Latvia;New Zealand;Slovakia;Spain;United Kingdom |
| 41 | EUCTR2011-004208-39-FR (EUCTR) | 22/03/2013 | 27/06/2013 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 | bronchiectasis MedDRA version: 16.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Slovakia;Spain;Israel;United Kingdom;Italy;France;United States;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan | ||
| 42 | EUCTR2011-004208-39-DK (EUCTR) | 12/03/2013 | 17/12/2012 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 | bronchiectasis MedDRA version: 17.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 400 | Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Brazil;Denmark;Australia;Latvia;Germany;New Zealand;Japan | |||
| 43 | EUCTR2011-004208-39-ES (EUCTR) | 29/01/2013 | 26/11/2012 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non-CF BE) | Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non-cystic fibrosis bronchiectasis. - RESPIRE 1 | bronchiectasis MedDRA version: 14.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan | ||
| 44 | EUCTR2011-004208-39-DE (EUCTR) | 21/01/2013 | 23/10/2012 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 | bronchiectasis MedDRA version: 18.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan | ||
| 45 | EUCTR2011-004208-39-IT (EUCTR) | 11/01/2013 | 11/12/2012 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 | bronchiectasis MedDRA version: 14.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: CIPROFLOXACIN | BAYER HEALTHCARE AG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan | ||
| 46 | NCT01768663 (ClinicalTrials.gov) | January 2013 | 11/1/2013 | A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult Subjects | A Phase 1, Open-Label Study to Examine the Effect of Ciprofloxacin, Itraconazole, and Rifampin on the Pharmacokinetics of Lumacaftor in Combination With Ivacaftor in Healthy Adult Subjects | Cystic Fibrosis | Drug: Lumacaftor;Drug: Ivacaftor;Drug: Ciprofloxacin;Drug: Itraconazole;Drug: Rifampin | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | 55 Years | Both | 80 | Phase 1 | United States |
| 47 | EUCTR2011-006171-19-IT (EUCTR) | 27/10/2011 | 13/01/2012 | Multicentric and randomized study to evaluate the effectiveness of the association of the 2 different treatments in the early P.aerugionsa infection in patient with cystic fibrosis disease. The study will enlist pazients over 5 years old. | randomized multicentric clinical trial upon efficacy of two different drugs combination to eradication of early p.aeruginosa infection in cystic fibrosis patients over 5 years old. | Cystic fibrosis patients with early P.aeruginosa infection. MedDRA version: 14.1;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: CIPROXIN*6CPR RIV 500MG INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE Trade Name: BRAMITOB*NEBUL 56F 300MG/4ML INN or Proposed INN: TOBRAMYCIN Trade Name: CIPROXIN*6CPR RIV 500MG INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE Trade Name: PROMIXIN*NEBUL 30MONOD 1MUI INN or Proposed INN: COLISTIN MESILATE SODIUM | AZIENDA OSPEDALIERA MEYER | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 48 | NCT01090908 (ClinicalTrials.gov) | September 2010 | 11/3/2010 | Evaluation of Ciprofloxacin for Inhalation to Cystic Fibrosis Patients With P. Aeruginosa | A Multi-Center, Open Label Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Ciprofloxacin For Inhalation (CFI) Given Daily For 14 Days To Stable Cystic Fibrosis Patients Ages 6 To 17 With Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: Antibiotic | Aradigm Corporation | NULL | Withdrawn | 6 Years | 18 Years | Both | 0 | N/A | NULL |
| 49 | EUCTR2009-014412-35-GB (EUCTR) | 23/02/2010 | 01/10/2009 | An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/A | An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/A | Non-cystic fibrosis bronchiectasis MedDRA version: 12.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS | Product Name: Ciprofloxacin for Inhalation Product Code: None assigned INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 96 | Germany;United Kingdom | |||
| 50 | NCT00889967 (ClinicalTrials.gov) | February 2010 | 27/4/2009 | Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis ORBIT-1 | An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared With Placebo for Inhalation in the Management of Pseudomonas Aeruginosa in Patients With Non Cystic Fibrosis Bronchiectasis | Non-Cystic Fibrosis Bronchiectasis | Drug: Ciprofloxacin for Inhalation;Drug: Placebo | Aradigm Corporation | NULL | Completed | 18 Years | 80 Years | All | 95 | Phase 2 | United States;Canada;Germany;United Kingdom |
| 51 | EUCTR2009-014412-35-DE (EUCTR) | 27/01/2010 | 09/10/2009 | An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/A | An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/A | Non-cystic fibrosis bronchiectasis MedDRA version: 12.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS | Product Name: Ciprofloxacin for Inhalation Product Code: None assigned INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | Germany;United Kingdom | ||
| 52 | EUCTR2009-012575-10-GB (EUCTR) | 16/11/2009 | 11/09/2009 | Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis - TORPEDO-CF | Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis - TORPEDO-CF | Product Name: Ceftazidime INN or Proposed INN: Ceftazidime Other descriptive name: N/A Product Name: Tobramycin INN or Proposed INN: Tobramycin Other descriptive name: N/A Product Name: Ciprofloxacin INN or Proposed INN: Ciprofloxacin Other descriptive name: N/A Product Name: Ciprofloxacin INN or Proposed INN: Ciprofloxacin Other descriptive name: N/A | University Hospitals Bristol NHS Foundation Trust | University of Liverpool | Not Recruiting | Female: yes Male: yes | 260 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom;Sweden | |||
| 53 | EUCTR2009-009869-34-SE (EUCTR) | 12/10/2009 | 29/07/2009 | Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939 | Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939 | Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of > 35 % and < 80 percent of predicted) MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis MedDRA version: 9.1;Level: PT;Term: Bronchiectasis | Product Name: Cipro Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | United Kingdom;Germany;Spain;Sweden | |||
| 54 | EUCTR2009-009869-34-GB (EUCTR) | 02/09/2009 | 09/04/2009 | Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939 | Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939 | Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of > 35 % and < 80 percent of predicted) MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis MedDRA version: 9.1;Level: PT;Term: Bronchiectasis | Product Name: Cipro Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Germany;United Kingdom;Spain;Sweden | |||
| 55 | EUCTR2009-009869-34-ES (EUCTR) | 03/07/2009 | 06/05/2009 | Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis. Estudio aleatorizado, controlado con placebo, en doble ciego y multicéntrico, para evaluar la seguridad y la eficacia de ciprofloxacino inhalado frente a placebo en pacientes con bronquiectasias no debidas a fibrosis quística. | Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis. Estudio aleatorizado, controlado con placebo, en doble ciego y multicéntrico, para evaluar la seguridad y la eficacia de ciprofloxacino inhalado frente a placebo en pacientes con bronquiectasias no debidas a fibrosis quística. | Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of greater than or equal to 35 % and less than or equal to 80 percent of predicted) Bronquiectasias idiopática y post-neumónica no debidas a fibrosis quística en pacientes en situación pulmonar estable (definida como mayor o igual al 35% y menor o igual al 80%) MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis MedDRA version: 9.1;Level: PT;Term: Bronchiectasis | Product Name: Cipro Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Germany;United Kingdom;Sweden | ||
| 56 | NCT00910351 (ClinicalTrials.gov) | July 2009 | 28/5/2009 | Cipro Inhaler for Cystic Fibrosis Children Ages 6-12 | A Study to Evaluate the Safety and Pharmacokinetics of Ciprofloxacin in Adults and Children Aged 6 - 12 Years With Cystic Fibrosis Following Inhalation of Ciprofloxacin Dry Powder | Pseudomonas Infection | Drug: Ciprofloxacin (Cipro, BAYQ3939) | Bayer | NULL | Completed | 6 Years | 12 Years | Both | 19 | Phase 1 | United States |
| 57 | EUCTR2008-008314-40-DE (EUCTR) | 22/06/2009 | 03/03/2009 | Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis | Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis | Cystic fibrosis MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 276 | Denmark;Germany;United Kingdom;Sweden | |||
| 58 | EUCTR2009-009869-34-DE (EUCTR) | 08/06/2009 | 17/03/2009 | Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939 | Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939 | Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of > 35 % and < 80 percent of predicted) MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis MedDRA version: 9.1;Level: PT;Term: Bronchiectasis | Product Name: Cipro Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Spain;Germany;United Kingdom;Sweden | |||
| 59 | EUCTR2006-003275-12-NO (EUCTR) | 03/06/2009 | 27/03/2009 | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa. MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Zitromax Product Name: Zitromax Product Code: Zitromax INN or Proposed INN: AZITHROMYCIN Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN | Copenhagen CF-centre | NULL | NA | Female: yes Male: yes | 250 | Phase 4 | Denmark;Norway;Sweden | ||
| 60 | EUCTR2008-008314-40-DK (EUCTR) | 02/06/2009 | 16/04/2009 | Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis | Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis | Cystic fibrosis MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 276 | United Kingdom;Germany;Denmark;Sweden | |||
| 61 | NCT00930982 (ClinicalTrials.gov) | June 2009 | 30/6/2009 | Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis | Randomized, Placebo-controlled, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of Ciprofloxacin Inhale Compared to Placebo in Patients With Non-cystic Fibrosis Bronchiectasis | Bronchiectasis | Drug: Ciprofloxacin (Cipro, BAYQ3939);Drug: Placebo | Bayer | Novartis | Completed | 18 Years | N/A | All | 124 | Phase 2 | United States;Australia;Germany;Spain;Sweden;United Kingdom |
| 62 | EUCTR2008-008314-40-GB (EUCTR) | 18/05/2009 | 09/04/2009 | Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis | Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis | Cystic fibrosis MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin | Bayer Healthcare AG | NULL | Not Recruiting | Female: yes Male: yes | 276 | Germany;United Kingdom;Denmark;Sweden | |||
| 63 | EUCTR2008-008314-40-SE (EUCTR) | 15/05/2009 | 25/03/2009 | Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis | Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis | Cystic fibrosis MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 276 | United Kingdom;Germany;Denmark;Sweden | |||
| 64 | EUCTR2008-001769-27-GB (EUCTR) | 29/09/2008 | 09/10/2008 | Microbiological assessment of prophylactic ciprofloxacin therapy for children with cystic fibrosis during viral respiratory viral infection to prevent Pseudomonas aeruginosa colonisation – a randomised control study (Prevent Pseudomonas Aeruginosa Colonisation- PREPAC) - PREPAC | Microbiological assessment of prophylactic ciprofloxacin therapy for children with cystic fibrosis during viral respiratory viral infection to prevent Pseudomonas aeruginosa colonisation – a randomised control study (Prevent Pseudomonas Aeruginosa Colonisation- PREPAC) - PREPAC | Cystic FibrosisSpecifically the trial will include children aged 2-14 years with a diagnosis of cystic fibrosis and not chronically infected with pseudomonas aeruginosa in their lungs. | Trade Name: Ciproxin Suspension Product Name: Ciproxin Product Code: PL 0010/0211 | Southampton University Hospital Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | United Kingdom | |||
| 65 | NCT00411736 (ClinicalTrials.gov) | May 2008 | 14/12/2006 | Scandinavian Cystic Fibrosis Azithromycin Study | Supplementary Oral Azithromycin in Treatment of Intermittent Pseudomonas Aeruginosa Colonization in CF-patients With Inhaled Colistin and Oral Ciprofloxacin; Postponing Next Isolate of Pseudomonas and Prevention of Chronic Infection. A Prospective, Double-blinded, Placebo-controlled Scandinavian Multi-centre Study. | Cystic Fibrosis | Drug: Study medication, azithromycin or placebo;Drug: Azithromycin or placebo tablets | Rigshospitalet, Denmark | Cystic Fibrosis Foundation Therapeutics | Completed | 1 Year | N/A | Both | 45 | Phase 4 | Denmark;Norway;Sweden |
| 66 | NCT00645788 (ClinicalTrials.gov) | May 2008 | 26/3/2008 | Study to Evaluate the Safety and Efficacy of Ciprofloxacin (Inhaled) in Patients With Cystic Fibrosis | Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Inhaled Ciprofloxacin Compared to Placebo in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: Ciprofloxacin (Cipro Inhale, BAYQ3939);Drug: Placebo | Bayer | Novartis | Completed | 12 Years | N/A | All | 288 | Phase 2 | United States;Australia;Canada;Denmark;Germany;Israel;Norway;Sweden;United Kingdom |
| 67 | EUCTR2008-006502-42-IT (EUCTR) | 22/04/2008 | 07/04/2010 | Early antibiotic treatment in pseudomonas aeruginosa eradication in cystic fibrosis patients: a randomised policentric study on two different protocols - #FFC17/2007 | Early antibiotic treatment in pseudomonas aeruginosa eradication in cystic fibrosis patients: a randomised policentric study on two different protocols - #FFC17/2007 | Cystic fibrosis MedDRA version: 9.1;Level: SOC;Classification code 10038738 | Trade Name: TOBI*NEBUL 56F 1D 300MG/5ML INN or Proposed INN: Tobramycin INN or Proposed INN: Colistin INN or Proposed INN: Ciprofloxacin | AZIENDA OSPEDALIERA MEYER | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 68 | EUCTR2007-002912-24-DE (EUCTR) | 30/10/2007 | 05/09/2007 | Study to evaluate the safety and pharmacokinetics of ciprofloxacin following inhalation of ciprofloxacin dry powder for inhalation administered to pediatric patients with cystic fibrosis aged 12-17 years | Study to evaluate the safety and pharmacokinetics of ciprofloxacin following inhalation of ciprofloxacin dry powder for inhalation administered to pediatric patients with cystic fibrosis aged 12-17 years | long term treatment of chronic lung infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Ciprofloxacin Product Code: BAY q 3939 INN or Proposed INN: CIPROFLOXACIN Other descriptive name: 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[1-piperazinyl]-3-quinoline carboxylic acid | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 16 | Germany | |||
| 69 | EUCTR2006-003275-12-DK (EUCTR) | 23/05/2007 | 17/04/2007 | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa. MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN | Copenhagen CF-centre | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Denmark | ||
| 70 | EUCTR2005-003837-42-GB (EUCTR) | 26/09/2005 | 24/08/2005 | CIPROFLOXACIN-INDUCED PHOTOTOXICITY IN PATIENTS WITH CYSTIC FIBROSIS - ciprofloxacin phototoxicity cystic fibrosis | CIPROFLOXACIN-INDUCED PHOTOTOXICITY IN PATIENTS WITH CYSTIC FIBROSIS - ciprofloxacin phototoxicity cystic fibrosis | infection - ciprofloxacin is used to treat various infections, for example respiratory tract infections, ear, nose and throat infections, eye infections, urinary tract infections. The main indication that is relevant to this application is its use in the treatment of chest infections in patients with cystic fibrosis. I have included the ICD classification for chest infection below. | Trade Name: Ciprofloxacin (ciproxin) Product Name: N/A Product Code: N/A | Belfast City Hospital Trust | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 71 | NCT00097773 (ClinicalTrials.gov) | September 2004 | 30/11/2004 | Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis | Effectiveness and Safety of Intermittent Antimicrobial Therapy for the Treatment of New Onset Pseudomonas Aeruginosa Airway Infection in Young Patients With Cystic Fibrosis | Cystic Fibrosis;Pulmonary Disease, Chronic Obstructive | Drug: Tobramycin solution for inhalation (TOBI);Drug: Oral placebo;Drug: Oral ciprofloxacin | Seattle Children's Hospital | National Heart, Lung, and Blood Institute (NHLBI);Cystic Fibrosis Foundation Therapeutics;CF Therapeutics Development Network Coordinating Center | Completed | 1 Year | 12 Years | All | 304 | Phase 2 | United States |
| 72 | NCT00153634 (ClinicalTrials.gov) | March 2004 | 8/9/2005 | Standard vs. Biofilm Susceptibility Testing in Cystic Fibrosis (CF) | Standard vs. Biofilm Susceptibility Testing in CF | Cystic Fibrosis;Chronic Bronchitis | Drug: IV amikacin;Drug: PO azithromycin;Drug: IV ceftazidime;Drug: PO ciprofloxacin;Drug: IV meropenem;Drug: IV piperacillin-tazobactam;Drug: IV ticarcillin-clavulanate;Drug: IV tobramycin | Seattle Children's Hospital | Cystic Fibrosis Foundation Therapeutics | Completed | 14 Years | N/A | Both | 75 | N/A | United States |
| 73 | NCT01400750 (ClinicalTrials.gov) | August 2001 | 18/7/2011 | Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis | Prospective Randomized Trial Comparing Oral Ciproxin Plus Inhaled Colistin With Tobramycin for Inhalation for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis. | Cystic Fibrosis | Drug: oral ciprofloxacin plus inhaled colistin;Drug: TOBI | Universitaire Ziekenhuizen Leuven | NULL | Completed | N/A | 18 Years | Both | 61 | Phase 4 | Belgium |
| 74 | EUCTR2006-003275-12-SE (EUCTR) | 07/07/2009 | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa. MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Trade Name: Azithromycin Product Name: azithromycin Product Code: azithromycin INN or Proposed INN: AZITHROMYCIN Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN | Copenhagen CF-centre | NULL | NA | Female: yes Male: yes | 250 | Phase 4 | Denmark;Norway;Sweden | |||
| 75 | EUCTR2009-012575-10-IT (EUCTR) | 18/01/2022 | Trial of Therapy for the first pulmonary infection by Pseudomonas aeruginosa in Cystic Fibrosis. | Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis - TORPEDO-FC | First Pseudomonas aeruginosa infection in patients with cystic fibrosis MedDRA version: 20.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOTTIZIM - 1 G/10 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO ENDOVENOSO 1 FLACONCINO POLVERE + 1 FIALA SOLVENTE 10 ML INN or Proposed INN: CEFTAZIDIMA PENTAIDRATO Other descriptive name: ceftazidime Trade Name: BRAMICIL - 100 MG/ 2 ML SOLUZIONE INIETTABILE 10 FIALE DA 2 ML Product Name: Tobramicina Product Code: tobramicina INN or Proposed INN: TOBRAMICINA SOLFATO Other descriptive name: Tobramicyn Trade Name: CIPROXIN - 500 MG COMPRESSE RIVESTITE 14 COMPRESSE Product Name: Ciprofloxacina INN or Proposed INN: CIPROFLOXACINA CLORIDRATO Other descriptive name: ciprofloxacin | UNIVERSITY OF LIVERPOOL | NULL | NA | Female: yes Male: yes | 286 | Phase 4 | United Kingdom;Italy;Sweden |