299. 嚢胞性線維症
［臨床試験数：1,592，薬物数：1,539（DrugBank：255），標的遺伝子数：81，標的パスウェイ数：162］
Searched query = "Cystic fibrosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
| 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 | 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 | ||
| 2 | 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 | |||
| 3 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Germany;Netherlands;New Zealand | |||
| 4 | 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 | ||
| 5 | 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 | ||
| 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 |
| 6 | 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 | ||
| 7 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | United States;Spain;Israel;United Kingdom;Italy;Hungary;Canada;Poland;Romania;Australia;South Africa;Georgia;Netherlands;Germany;Latvia;New Zealand | |||
| 8 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | United States;Spain;Ireland;Israel;United Kingdom;Italy;Hungary;Canada;Poland;Romania;Australia;South Africa;Georgia;Netherlands;Germany;Latvia;New Zealand | |||
| 9 | 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 | ||
| 10 | 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 | ||
| 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 |
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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® (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 (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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | Serbia;United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Georgia;Germany;New Zealand | |||
| 15 | 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® (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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 255 | United States;Spain;Ireland;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;South Africa;Germany;Latvia | |||
| 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 |
| 16 | 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 | ||
| 17 | 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 | ||
| 18 | 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 | ||||
| 19 | 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 | |||
| 20 | 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 |