Lysine (DrugBank: Lysine)
4 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 13 | 多発性硬化症／視神経脊髄炎 | 1 |
| 97 | 潰瘍性大腸炎 | 2 |
| 228 | 閉塞性細気管支炎 | 1 |
| 299 | 嚢胞性線維症 | 53 |
| 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 | EUCTR2017-002838-23-ES (EUCTR) | 27/10/2017 | 21/07/2017 | Randomized, double-blind, placebo-controlled, 3-arm, 36 weeks parallel-group study to evaluate the safety and tolerability of ORY-2001 in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS) | Randomized, double-blind, placebo-controlled, 3-arm, 36 weeks parallel-group study to evaluate the safety and tolerability of ORY-2001 in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS) | patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Secondary Progressive Multiple Sclerosis (SPMS) MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ORY2001 Product Code: ORY2001 INN or Proposed INN: Not yet requested Other descriptive name: PHENYLCYCLOPROPYLAMINE DERIVATIVES AND DUAL LSD1/MAO-B (LYSINE-SPECIFIC DEMETHYLASE 1 AND MONOAMINE OXIDASE-B) INHIBITOR | Oryzon Genomics S. A | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | Spain |
| 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 | EUCTR2011-002462-20-IT (EUCTR) | 02/01/2012 | 08/03/2012 | Prospective clinical study, where patients are receiving or the study drug or an inactive drug called placebo wihtout knowing which of the two drugs is taken, even the Investigator is aware of the therapy taken by the patients. Patients are assigned to a specific treatment according to a randomization list. The study is performed to assess the effects and tolerability of K(D)PT in ulcerative colitis. | Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis:PoC study | mild to moderate ulcerative colitis MedDRA version: 14.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Lysine-D-proline-threonine Product Code: K(D)PT INN or Proposed INN: NA Other descriptive name: L-Lysyl-D-Prolyl-LThreonine acetate, lyophilisate | DR. AUGUST WOLFF GMBH & CO. KG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Hungary;Czech Republic;Slovakia;Poland;Germany;Italy | |||
| 2 | EUCTR2010-023494-19-SE (EUCTR) | 10/02/2011 | 27/12/2010 | A Phase IIa, Multi-Centre, Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of K(D)PT after Multiple Ascending Doses in Patients with Active Mild to Moderate Ulcerative Colitis | A Phase IIa, Multi-Centre, Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of K(D)PT after Multiple Ascending Doses in Patients with Active Mild to Moderate Ulcerative Colitis | Ulcerative colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Lysine-D-Proline-Threonine Product Code: K(D)PT | Dr. August Wolff GmbH & Co. KG Arzneimittel | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Sweden |
| 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 | NCT01469364 (ClinicalTrials.gov) | March 2013 | 8/11/2011 | Safety Study of Aztreonam Lysine for Inhalation (AZLI) in the Treatment of Early Bronchiolitis Obliterans Syndrome (BOS) | Aztreonam Lysine for Inhalation (AZLI) in the Treatment of Early Bronchiolitis Obliterans Syndrome (BOS) After Lung Transplantation | Complication of Transplanted Lung | Drug: Aztreonam Lysine for Inhalation (AZLI);Procedure: Status Post Lung Transplant | Duke University | Gilead Sciences | Completed | 18 Years | N/A | All | 30 | Phase 4 | United States |
| 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 | EUCTR2016-002749-42-NL (EUCTR) | 09/05/2018 | 29/08/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Netherlands;Germany | ||
| 2 | EUCTR2016-002749-42-GR (EUCTR) | 12/01/2018 | 03/10/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands | ||
| 3 | EUCTR2016-002749-42-DK (EUCTR) | 15/12/2017 | 11/10/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 21.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| 4 | EUCTR2016-002749-42-IT (EUCTR) | 24/11/2017 | 14/09/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| 5 | EUCTR2016-002749-42-GB (EUCTR) | 09/10/2017 | 25/07/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 21.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands | ||
| 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 | EUCTR2016-002749-42-DE (EUCTR) | 22/09/2017 | 02/08/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 21.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| 7 | EUCTR2016-002749-42-BE (EUCTR) | 18/09/2017 | 24/07/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands | ||
| 8 | EUCTR2016-002749-42-AT (EUCTR) | 07/08/2017 | 27/07/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 21.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| 9 | EUCTR2016-002749-42-ES (EUCTR) | 04/08/2017 | 08/08/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | France;United States;Greece;Belgium;Spain;Ireland;Austria;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 10 | EUCTR2013-004295-35-AT (EUCTR) | 30/04/2014 | 02/04/2014 | Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study | Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study - LCI-OUT | Chronic lung P. Aeruginosa Infection MedDRA version: 16.1;Level: PT;Classification code 10061229;Term: Lung infection;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler Product Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler INN or Proposed INN: aztreonam Other descriptive name: AZTREONAM LYSINE Trade Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel Product Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel INN or Proposed INN: COLISTIMETHATE SODIUM Trade Name: TOBI Product Name: Tobi INN or Proposed INN: TOBRAMYCIN SULFATE | Medical University Innsbruck - Department für Kinder- und Jugendheilkunde (Pädiatrie III) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Austria | ||||
| 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 | EUCTR2011-001255-36-AT (EUCTR) | 25/06/2012 | 18/10/2011 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | France;United States;Belgium;Spain;Poland;Ireland;Austria;Netherlands;Germany;Italy | ||
| 12 | EUCTR2011-001362-18-DE (EUCTR) | 19/03/2012 | 20/12/2011 | Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways - PALS (Pediatric Aztreonam Lysine Safety) | cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | France;United States;Spain;Poland;Germany;Italy | ||
| 13 | EUCTR2011-001255-36-NL (EUCTR) | 13/03/2012 | 19/10/2011 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | United States;France;Spain;Poland;Belgium;Ireland;Austria;Germany;Netherlands;Italy | ||
| 14 | EUCTR2011-001362-18-IT (EUCTR) | 08/02/2012 | 22/02/2012 | Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteria. | Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways. - PALS (Pediatric Aztreonam Lysine Safety) | Cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa. MedDRA version: 14.1;Level: SOC;Classification code 10021881;Term: Infections and infestations;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: PT;Classification code 10056971;Term: Infective exacerbation of chronic obstructive airways disease;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: CAYSTON aztreonam 75 mg powder and solvent for nebuliser solution INN or Proposed INN: AZTREONAM Other descriptive name: NA | GILEAD SCIENCES INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | Germany;Spain;Italy;United States | ||
| 15 | EUCTR2011-001255-36-BE (EUCTR) | 07/02/2012 | 13/10/2011 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | France;United States;Spain;Poland;Belgium;Ireland;Austria;Netherlands;Germany;Italy | ||
| 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 | EUCTR2011-001255-36-IE (EUCTR) | 06/02/2012 | 24/10/2011 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;United States;Belgium;Spain;Poland;Ireland;Austria;Netherlands;Germany;Italy | ||
| 17 | EUCTR2011-001255-36-IT (EUCTR) | 27/01/2012 | 28/09/2012 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients with Cystic Fibrosis (CF) and New Onset Lower Respiratory Tract Culture Positive for Pseudomonas aeruginosa (PA) Aztreonam Lysine for Pseudomonas Infection Eradication (ALPINE)study - ALPINE | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 15.0;Level: PT;Classification code 10056971;Term: Infective exacerbation of chronic obstructive airways disease;System Organ Class: 10021881 - Infections and infestations MedDRA version: 15.0;Level: SOC;Classification code 10021881;Term: Infections and infestations;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Aztreonam 75 mg powder and solvent for nebuliser solution INN or Proposed INN: AZTREONAM | GILEAD SCIENCES INC. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;Spain;Ireland;Austria;Netherlands;Germany;Italy | ||
| 18 | EUCTR2011-001362-18-ES (EUCTR) | 25/01/2012 | 21/12/2011 | Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mgPowder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways - PALS (Pediatric Aztreonam Lysine Safety) | Cystic fibrosis and chronic infection of lower respiratory tract withPseudomonas aeruginosa MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam solución para inhalación Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | Germany;France;Spain;Italy;United States;Poland | ||
| 19 | EUCTR2011-001255-36-DE (EUCTR) | 16/01/2012 | 11/10/2011 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | United States;France;Spain;Poland;Belgium;Ireland;Austria;Netherlands;Germany;Italy | ||
| 20 | EUCTR2011-001255-36-ES (EUCTR) | 23/11/2011 | 18/10/2011 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for P.aeruginosa. MedDRA version: 14.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 2 | Germany;Netherlands;Belgium;France;Ireland;Spain;Italy;United States;Poland;Austria | ||
| 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 |
| 21 | NCT01375049 (ClinicalTrials.gov) | August 2011 | 15/6/2011 | Aztreonam Lysine for Pseudomonas Infection Eradication Study | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients With Cystic Fibrosis (CF) and New Onset Lower Respiratory Tract Culture Positive for Pseudomonas Aeruginosa (PA) | Cystic Fibrosis | Drug: Aztreonam for Inhalation Solution (AZLI) | Gilead Sciences | NULL | Completed | 3 Months | 17 Years | All | 105 | Phase 2 | United States;Austria;Belgium;France;Germany;Italy;Netherlands;Poland;Spain;Ireland |
| 22 | EUCTR2010-018454-13-DK (EUCTR) | 27/10/2010 | 13/08/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | France;Czech Republic;Hungary;Spain;Belgium;Denmark;Germany;United Kingdom;Italy | ||
| 23 | EUCTR2010-018454-13-ES (EUCTR) | 06/09/2010 | 31/05/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®Estudio de fase III multicéntrico, doble ciego, aleatorizado y controlado con placebo de la incidencia de recurrencia de las exacerbaciones pulmonares en pacientes con fibrosis quística utilizando dos dosis diferentes de Nacystelyn® inhalado | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®Estudio de fase III multicéntrico, doble ciego, aleatorizado y controlado con placebo de la incidencia de recurrencia de las exacerbaciones pulmonares en pacientes con fibrosis quística utilizando dos dosis diferentes de Nacystelyn® inhalado | Cystic fibrosisFibrosis quistica MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine- N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine- N-acetylcysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | France;Czech Republic;Hungary;Belgium;Spain;Denmark;Germany;United Kingdom;Italy | ||
| 24 | EUCTR2010-018454-13-GB (EUCTR) | 01/09/2010 | 18/06/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | Hungary;Czech Republic;Germany;United Kingdom;France;Spain;Italy | ||
| 25 | EUCTR2010-018454-13-DE (EUCTR) | 31/08/2010 | 21/05/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Italy | ||
| 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 |
| 26 | EUCTR2010-018454-13-CZ (EUCTR) | 27/08/2010 | 21/06/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | Hungary;United Kingdom;Germany;Czech Republic;France;Spain;Italy | ||
| 27 | EUCTR2010-018454-13-HU (EUCTR) | 17/08/2010 | 17/06/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Italy | ||
| 28 | EUCTR2010-018454-13-FR (EUCTR) | 10/08/2010 | 28/05/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | France;Czech Republic;Hungary;Spain;Belgium;Denmark;Germany;United Kingdom;Italy | ||
| 29 | EUCTR2010-018454-13-IT (EUCTR) | 15/07/2010 | 15/06/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn - ND | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn - ND | Cystic fibrosis MedDRA version: 9.1;Level: PT;Classification code 10011762 | Product Name: Nacystelyn Product Code: NAL INN or Proposed INN: L-Lysine N acetylcysteinate Product Name: Nacystelyn Product Code: NAL INN or Proposed INN: L-Lysine N-acetylcysteinate | LABORATOIRES SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Italy | ||
| 30 | NCT01460836 (ClinicalTrials.gov) | April 2010 | 25/10/2011 | Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis | Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis | Cystic Fibrosis | Drug: Tobramycin solution for inhalation;Drug: Aztreonam lysine for inhalation | Novartis Pharmaceuticals | NULL | Completed | 6 Years | N/A | Both | N/A | NULL | |
| 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 |
| 31 | EUCTR2007-004277-26-AT (EUCTR) | 21/01/2010 | 21/04/2009 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Cayston Product Name: AZLI Product Code: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 32 | NCT00989807 (ClinicalTrials.gov) | September 2009 | 2/10/2009 | Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis | Expanded Access for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease Progression | Cystic Fibrosis;Pseudomonas Aeruginosa | Drug: Aztreonam lysine | Gilead Sciences | NULL | Approved for marketing | 6 Years | N/A | Both | N/A | Canada | |
| 33 | EUCTR2007-004277-26-GB (EUCTR) | 12/03/2009 | 08/02/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Cayston Product Name: AZLI Product Code: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 34 | EUCTR2007-004277-26-PT (EUCTR) | 12/12/2008 | 17/10/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI Product Code: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 35 | EUCTR2007-004277-26-DE (EUCTR) | 14/10/2008 | 29/05/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Cayston Product Name: AZLI Product Code: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 3 | Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 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 |
| 36 | EUCTR2007-004277-26-ES (EUCTR) | 25/08/2008 | 24/01/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisEnsayo de fase III, abierto, aleatorizado para evaluar la eficacia y seguridad de aztreonam lisina para inhalación frente a una solución de tobramicina para nebulizador en un régimen intermitente de antibiótico en aerosol en pacientes con fibrosis quística | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisEnsayo de fase III, abierto, aleatorizado para evaluar la eficacia y seguridad de aztreonam lisina para inhalación frente a una solución de tobramicina para nebulizador en un régimen intermitente de antibiótico en aerosol en pacientes con fibrosis quística | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. Pacientes adultos y pediátricos con fibrosis quística (FQ) con infección pulmonar por Pseudomonas aeruginosa (PA). MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 37 | EUCTR2007-004277-26-IE (EUCTR) | 19/06/2008 | 27/02/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 38 | EUCTR2007-004277-26-NL (EUCTR) | 10/06/2008 | 29/05/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open-Label, Single Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open-Label, Single Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 39 | NCT00712166 (ClinicalTrials.gov) | May 2008 | 7/7/2008 | Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa | A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine For Inhalation in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa (AIR-CF4) | Cystic Fibrosis;Lung Infection;Pseudomonas Aeruginosa | Drug: AZLI 75 mg three times daily (TID);Drug: Placebo three times daily (TID) | Gilead Sciences | NULL | Completed | 6 Years | N/A | All | 160 | Phase 3 | United States;Australia;Canada |
| 40 | EUCTR2007-004277-26-FR (EUCTR) | 30/04/2008 | 21/01/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 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 |
| 41 | EUCTR2007-004277-26-BE (EUCTR) | 29/04/2008 | 20/12/2007 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 273 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 42 | EUCTR2007-004277-26-IT (EUCTR) | 23/04/2008 | 17/06/2008 | An open-label, randomised, phase 3 trial to evaluate the efficacy and safety of Aztreonan LYsine for inhalation versus Tobramycin nebuliser solution in an intermittent aerosolized antibiotic regimen in patients with cystic fibrosis. - ND | An open-label, randomised, phase 3 trial to evaluate the efficacy and safety of Aztreonan LYsine for inhalation versus Tobramycin nebuliser solution in an intermittent aerosolized antibiotic regimen in patients with cystic fibrosis. - ND | Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: aztreonan lysine Product Code: AZLI INN or Proposed INN: Aztreonam Trade Name: TOBI*NEBUL 56F 1D 300MG/5ML INN or Proposed INN: Tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 43 | EUCTR2007-004277-26-DK (EUCTR) | 16/04/2008 | 12/03/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 3 | Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 44 | NCT00499720 (ClinicalTrials.gov) | October 2003 | 9/7/2007 | Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection | Expanded Access Program for Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease Progression | Cystic Fibrosis;Pseudomonas Aeruginosa Airway Infection | Drug: Aztreonam Lysine for Inhalation | Gilead Sciences | NULL | Approved for marketing | 6 Years | N/A | Both | N/A | United States;Puerto Rico | |
| 45 | EUCTR2016-002749-42-IE (EUCTR) | 26/07/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands | ||||
| 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 |
| 46 | EUCTR2015-000395-97-Outside-EU/EEA (EUCTR) | 02/02/2015 | A Clinical Trial to Evaluate the Effects of the drug Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis, Mild Lung Disease, and infection with the bacteria Pseudomonas aeruginosa (AIR-CF4) | A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis, Mild Lung Disease, and P. aeruginosa (AIR-CF4) | Cystic Fibrosis with Mild Lung Disease and P. aeruginosa (AIR-CF4);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | Gilead Sciences Pty Ltd;Gilead Sciences Canada, Inc. | NA | Female: yes Male: yes | 157 | United States;Australia;Canada | ||||
| 47 | EUCTR2011-001255-36-FR (EUCTR) | 14/10/2011 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 14.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 80 | Phase 2 | United States;France;Belgium;Spain;Poland;Ireland;Austria;Netherlands;Germany;Italy | |||
| 48 | EUCTR2015-000396-26-Outside-EU/EEA (EUCTR) | 02/02/2015 | Program to Give the Drug Aztreonam Lysine for Inhalation to Patients with Cystic Fibrosis and infection by the Bacteria Pseudomonas aeruginosa Who Have Limited Treatment Options and are at Risk for Disease Progression | Expanded Access Program for Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis and Pseudomonas aeruginosa Airway Infection Who Have Limited Treatment Options and are at Risk for Disease Progression | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 603 | United States | ||||
| 49 | EUCTR2011-001255-36-Outside-EU/EEA (EUCTR) | 02/02/2015 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 105 | Phase 2 | United States | |||
| 50 | EUCTR2010-018454-13-BE (EUCTR) | 25/05/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetyl-L-cysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetyl-L-cysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | France;Czech Republic;Hungary;Spain;Belgium;Denmark;Germany;United Kingdom;Italy | |||
| 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 |
| 51 | EUCTR2015-000397-36-Outside-EU/EEA (EUCTR) | 03/02/2015 | Program to Give the Drug Aztreonamn Lysine for Inhalation to Canadian Patients with Cystic Fibrosis and infection by the Bacteria Pseudomonas aeruginosa Who Have Limited Treatment Options and are at Risk for Disease Progression | Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients with Cystic Fibrosis and Pseudomonas aeruginosa Airway Infection Who Have Limited Treatment Options and are at Risk for Disease Progression | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 45 | Canada | ||||
| 52 | EUCTR2011-001362-18-Outside-EU/EEA (EUCTR) | 02/02/2015 | Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways - PALS (Pediatric Aztreonam Lysine Safety) | cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | United States | |||
| 53 | EUCTR2011-001362-18-FR (EUCTR) | 05/01/2012 | Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways - PALS (Pediatric Aztreonam Lysine Safety) | cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | United States;France;Spain;Poland;Germany;Italy |