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.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
63 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-002749-42-NL
(EUCTR)
09/05/201829/08/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Netherlands;Germany
2EUCTR2016-002749-42-GR
(EUCTR)
12/01/201803/10/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands
3EUCTR2016-002749-42-DK
(EUCTR)
15/12/201711/10/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
4NCT03219164
(ClinicalTrials.gov)
November 28, 201713/7/2017Safety and Efficacy of 2 Treatment Regimens of Aztreonam for Inhalation Solution in Children With Cystic Fibrosis and New Onset Pseudomonas Aeruginosa InfectionRandomized, 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/ColonizationPseudomonas Aeruginosa Respiratory Tract Infection;Cystic FibrosisDrug: AZLI;Drug: PlaceboGilead SciencesNULLActive, not recruiting3 Months18 YearsAll149Phase 3United States;Austria;Belgium;Denmark;France;Germany;Greece;Israel;Italy;Netherlands;Spain;United Kingdom
5EUCTR2016-002749-42-IT
(EUCTR)
24/11/201714/09/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2016-002749-42-GB
(EUCTR)
09/10/201725/07/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands
7EUCTR2016-002749-42-DE
(EUCTR)
22/09/201702/08/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
8EUCTR2016-002749-42-BE
(EUCTR)
18/09/201724/07/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands
9EUCTR2016-002749-42-AT
(EUCTR)
07/08/201727/07/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
10EUCTR2016-002749-42-ES
(EUCTR)
04/08/201708/08/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 3France;United States;Greece;Belgium;Spain;Ireland;Austria;Israel;Netherlands;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT02894684
(ClinicalTrials.gov)
January 20171/9/2016Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic FibrosisAztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis. An Randomised, Crossover Pilot Study of AZLI Plus Intravenous Colistin® Versus Standard Dual Intravenous TherapyCystic Fibrosis;Infection;PseudomonasDrug: Aztreonam;Drug: Standard CareLiverpool Heart and Chest Hospital NHS Foundation TrustUniversity of LiverpoolCompleted16 Years65 YearsMale16Phase 4United Kingdom
12NCT02730793
(ClinicalTrials.gov)
January 20173/11/2015Aztreonam Aerosol to Treat Cystic Fibrosis Nasal DiseaseAztreonam Aerosol to Treat Cystic Fibrosis Nasal DiseaseCystic FibrosisDrug: Oral Aztreonam;Drug: Nasal Aztreonam;Drug: Nasal PlaceboVirginia Commonwealth UniversityEastern Virginia Medical SchoolCompleted7 Years100 YearsAll10Phase 2United States
13EUCTR2016-002832-34-GB
(EUCTR)
11/11/201603/10/2016The use of an inhaled antibiotic called Cayston to treat acute chest infections in people with CFAztreonam for inhalation for the treatment of acute exacerbations in cystic fibrosis. An open-label, randomised, cross-over pilot study of AZLI plus intravenous Colistin versus standard dual intravenous therapy. - AZTEC-CF Cystic fibrosis
MedDRA version: 19.0;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: Cayston
INN or Proposed INN: Aztreonam
Other descriptive name: Cayston
Liverpool Heart & Chest HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 4United Kingdom
14NCT02453789
(ClinicalTrials.gov)
February 201514/5/2015A Study of OligoG in Cystic Fibrosis Subjects With Burkholderia Spp. InfectionA Randomized Double-blind, Placebo-controlled Cross-over Study of Inhaled Alginate Oligosaccharide (OligoG) for 28 Days in Subjects With Cystic Fibrosis Using Aztreonam Due to Chronic Colonization With Burkholderia Spp.Cystic Fibrosis;Burkholderia InfectionDrug: Alginate oligosaccharide;Drug: PlaceboAlgiPharma ASNULLCompleted18 YearsN/AAll15Phase 2Germany
15EUCTR2014-002125-35-DE
(EUCTR)
18/12/201421/07/2014A phase IIb study of OligoG in subjects with cystic fibrosis colonized with Burkholderia spp.A randomized double-blind, placebo-controlled cross-over study of inhaled alginate oligosaccharide (OligoG) for 28 days in subjects with Cystic Fibrosis using aztreonam due to chronic colonization with Burkholderia spp. - A phase IIb study of OligoG in subjects with cystic fibrosis colonized with Burkholderia spp. Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: OligoG CF-5/20
INN or Proposed INN: Oligomer of Sodium Alginate
Other descriptive name: OLIGOG CF-5/20
Algipharma ASNULLNot RecruitingFemale: yes
Male: yes
12Phase 2Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2013-004295-35-AT
(EUCTR)
30/04/201402/04/2014Lung 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 studyLung 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)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Austria
17NCT01641822
(ClinicalTrials.gov)
December 201213/7/2012Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CFA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas Aeruginosa Infection in Subjects With Cystic FibrosisCystic FibrosisDrug: AZLI;Drug: Placebo to match AZLI;Drug: Tobramycin inhalation solutionGilead SciencesNULLCompleted6 YearsN/AAll107Phase 3United States
18EUCTR2011-001255-36-AT
(EUCTR)
25/06/201218/10/2011Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-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.NULLNot RecruitingFemale: yes
Male: yes
105Phase 2France;United States;Belgium;Spain;Poland;Ireland;Austria;Netherlands;Germany;Italy
19EUCTR2011-001362-18-DE
(EUCTR)
19/03/201220/12/2011Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-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.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3France;United States;Spain;Poland;Germany;Italy
20EUCTR2011-001255-36-NL
(EUCTR)
13/03/201219/10/2011Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-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.NULLNot RecruitingFemale: yes
Male: yes
105Phase 2United States;France;Spain;Poland;Belgium;Ireland;Austria;Germany;Netherlands;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2011-001362-18-IT
(EUCTR)
08/02/201222/02/2012Study 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3Germany;Spain;Italy;United States
22EUCTR2011-001255-36-BE
(EUCTR)
07/02/201213/10/2011Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-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.NULLNot RecruitingFemale: yes
Male: yes
105Phase 2France;United States;Spain;Poland;Belgium;Ireland;Austria;Netherlands;Germany;Italy
23EUCTR2011-001255-36-IE
(EUCTR)
06/02/201224/10/2011Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-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.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;United States;Belgium;Spain;Poland;Ireland;Austria;Netherlands;Germany;Italy
24EUCTR2011-001255-36-IT
(EUCTR)
27/01/201228/09/2012Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-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.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2United States;Spain;Ireland;Austria;Netherlands;Germany;Italy
25EUCTR2011-001362-18-ES
(EUCTR)
25/01/201221/12/2011Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3Germany;France;Spain;Italy;United States;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2011-001255-36-DE
(EUCTR)
16/01/201211/10/2011Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-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.NULLNot RecruitingFemale: yes
Male: yes
105Phase 2United States;France;Spain;Poland;Belgium;Ireland;Austria;Netherlands;Germany;Italy
27NCT01404234
(ClinicalTrials.gov)
December 201126/7/2011Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower AirwaysOpen-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 AirwaysCystic Fibrosis;Pseudomonas AeruginosaDrug: AZLIGilead SciencesNULLCompletedN/A12 YearsAll61Phase 3United States;France;Germany;Italy;Poland;Spain
28EUCTR2011-001255-36-ES
(EUCTR)
23/11/201118/10/2011Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 2Germany;Netherlands;Belgium;France;Ireland;Spain;Italy;United States;Poland;Austria
29NCT01375049
(ClinicalTrials.gov)
August 201115/6/2011Aztreonam Lysine for Pseudomonas Infection Eradication StudyOpen-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 FibrosisDrug: Aztreonam for Inhalation Solution (AZLI)Gilead SciencesNULLCompleted3 Months17 YearsAll105Phase 2United States;Austria;Belgium;France;Germany;Italy;Netherlands;Poland;Spain;Ireland
30NCT01313624
(ClinicalTrials.gov)
April 201110/3/2011Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis BronchiectasisA Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial InfectionBronchiectasisDrug: AZLI;Drug: PlaceboGilead SciencesNULLCompleted18 YearsN/AAll266Phase 3United States;Australia;Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT01314716
(ClinicalTrials.gov)
April 201111/3/2011Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis BronchiectasisA Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2)BronchiectasisDrug: AZLI;Drug: PlaceboGilead SciencesNULLCompleted18 YearsN/AAll274Phase 3United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom
32NCT01460836
(ClinicalTrials.gov)
April 201025/10/2011Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic FibrosisIndirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic FibrosisCystic FibrosisDrug: Tobramycin solution for inhalation;Drug: Aztreonam lysine for inhalationNovartis PharmaceuticalsNULLCompleted6 YearsN/ABothN/ANULL
33NCT01059565
(ClinicalTrials.gov)
February 201028/1/2010Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis and Chronic Burkholderia Species InfectionPhase 3b Randomized, Double-Blind, Placebo-Controlled Two-Part Trial to Assess the Safety and Efficacy of Continuous Aztreonam for Inhalation Solution (AZLI) in Subjects With Cystic Fibrosis (CF) and Chronic Burkholderia Species InfectionCystic Fibrosis;Burkholderia InfectionsDrug: AZLI;Drug: PlaceboGilead SciencesNULLCompleted6 YearsN/AAll102Phase 3United States;Canada
34EUCTR2007-004277-26-AT
(EUCTR)
21/01/201021/04/2009An 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 ExtensionAn 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 IncNULLNot RecruitingFemale: yes
Male: yes
273Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
35NCT00989807
(ClinicalTrials.gov)
September 20092/10/2009Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic FibrosisExpanded 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 ProgressionCystic Fibrosis;Pseudomonas AeruginosaDrug: Aztreonam lysineGilead SciencesNULLApproved for marketing6 YearsN/ABothN/ACanada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2007-004277-26-GB
(EUCTR)
12/03/200908/02/2008An 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 ExtensionAn 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 IncNULLNot RecruitingFemale: yes
Male: yes
273Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
37EUCTR2007-004277-26-PT
(EUCTR)
12/12/200817/10/2008An 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 ExtensionAn 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 IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
38EUCTR2007-004277-26-DE
(EUCTR)
14/10/200829/05/2008An 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 ExtensionAn 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 IncNULLNot RecruitingFemale: yes
Male: yes
273Phase 3Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom
39EUCTR2007-004277-26-ES
(EUCTR)
25/08/200824/01/2008An 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 quísticaAn 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 IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
40NCT00757237
(ClinicalTrials.gov)
August 200822/9/2008Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas AeruginosaAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam for Inhalation Solution (AZLI) Versus Tobramycin Inhalation Solution (TIS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects With Cystic Fibrosis Followed by an Open-Label, Single Arm Extension (European Union [EU] Only)Cystic FibrosisDrug: Aztreonam for Inhalation Solution (AZLI);Drug: Tobramycin Inhalation Solution (TIS)Gilead SciencesChiltern International Inc.;ClinPhone, Inc.;CovanceCompleted6 YearsN/AAll274Phase 3United States;Austria;Belgium;Denmark;France;Germany;Ireland;Italy;Netherlands;Portugal;Spain;Switzerland;United Kingdom;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2007-004277-26-IE
(EUCTR)
19/06/200827/02/2008An 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 FibrosisAn 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 IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria
42EUCTR2007-004277-26-NL
(EUCTR)
10/06/200829/05/2008An 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 ExtensionAn 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 IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
43NCT00712166
(ClinicalTrials.gov)
May 20087/7/2008Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. AeruginosaA 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 AeruginosaDrug: AZLI 75 mg three times daily (TID);Drug: Placebo three times daily (TID)Gilead SciencesNULLCompleted6 YearsN/AAll160Phase 3United States;Australia;Canada
44EUCTR2007-004277-26-FR
(EUCTR)
30/04/200821/01/2008An 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 FibrosisAn 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 IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
45EUCTR2007-004277-26-BE
(EUCTR)
29/04/200820/12/2007An 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 ExtensionAn 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 IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
273Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2007-004277-26-IT
(EUCTR)
23/04/200817/06/2008An 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. - NDAn 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 IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
47EUCTR2007-004277-26-DK
(EUCTR)
16/04/200812/03/2008An 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 ExtensionAn 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 IncNULLNot RecruitingFemale: yes
Male: yes
273Phase 3Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom
48NCT00128492
(ClinicalTrials.gov)
August 20058/8/2005Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)A Phase 3, Open-label, Follow-On Study of Multiple Courses of Aztreonam Lysinate for Inhalation (AI) in Cystic Fibrosis Patients (AIR-CF3)Cystic FibrosisDrug: AZLI 75 mg two times a day (BID)/ three times a day (TID)Gilead SciencesNULLCompleted6 YearsN/AAll274Phase 3United States;Australia;Canada;New Zealand
49NCT00112359
(ClinicalTrials.gov)
May 20051/6/2005International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. AeruginosaA Phase 3, Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary Pseudomonas Aeruginosa (AIR-CF1)Cystic FibrosisDrug: AZLI 75 mg three times a day (TID);Drug: Placebo three times a day (TID)Gilead SciencesNULLCompleted6 YearsN/AAll166Phase 3United States;Australia;Canada;New Zealand
50NCT00104520
(ClinicalTrials.gov)
February 20051/3/2005Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. AeruginosaA Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2)Cystic FibrosisDrug: AZLI 75 mg two times a day (BID)/three times a day (TID);Drug: Placebo two times a day (BID)/three times a day (TID)Gilead SciencesNULLCompleted6 YearsN/AAll211Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT00499720
(ClinicalTrials.gov)
October 20039/7/2007Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway InfectionExpanded 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 ProgressionCystic Fibrosis;Pseudomonas Aeruginosa Airway InfectionDrug: Aztreonam Lysine for InhalationGilead SciencesNULLApproved for marketing6 YearsN/ABothN/AUnited States;Puerto Rico
52NCT01055847
(ClinicalTrials.gov)
June 200323/1/2010Aztreonam for Inhalation (AI) in Patients With Cystic Fibrosis & P. Aeruginosa InfectionA Blinded, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam for Inhalation (AI) in Cystic Fibrosis Patient With Lung Disease Due to P. Aeruginosa InfectionCystic Fibrosis;CF;Lung Infection;Pseudomonas AeruginosaDrug: Aztreonam for Inhalation (AI);Drug: PlaceboGilead SciencesConducted under Salus Pharma, Inc.Completed13 YearsN/ABoth105Phase 2United States
53EUCTR2011-001362-18-Outside-EU/EEA
(EUCTR)
02/02/2015Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-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.NULLNAFemale: yes
Male: yes
60Phase 3United States
54EUCTR2015-000395-97-Outside-EU/EEA
(EUCTR)
02/02/2015A 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.NAFemale: yes
Male: yes
157United States;Australia;Canada
55EUCTR2007-004277-26-Outside-EU/EEA
(EUCTR)
02/02/2015A Clinical Trial to Evaluate the Efficacy and Safety of the drug Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) in comparison to the drug Tobramycin Nebulizer Solution (TNS) in patients with Cystic Fibrosis.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.;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Cayston
INN or Proposed INN: AZTREONAM
Trade Name: TOBI
INN or Proposed INN: TOBRAMYCIN
Other descriptive name: TOBRAMYCIN
Gilead Sciences IncNULLNAFemale: yes
Male: yes
268Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2016-002749-42-IE
(EUCTR)
26/07/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, 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.NULLNot Recruiting Female: yes
Male: yes
140 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands
57EUCTR2015-000397-36-Outside-EU/EEA
(EUCTR)
03/02/2015Program 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 ProgressionExpanded 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.NULLNAFemale: yes
Male: yes
45Canada
58EUCTR2011-001255-36-Outside-EU/EEA
(EUCTR)
02/02/2015Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-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.NULLNAFemale: yes
Male: yes
105Phase 2United States
59EUCTR2015-000398-11-Outside-EU/EEA
(EUCTR)
03/02/2015A Clinical Trial to Assess the Safety and Efficacy of an Alternating Therapy of Antibiotics with the Drug Aztreonam for Inhalation Solution (AZLI) for the Treatment of Lung Infection by the bacteria Pseudomonas aeruginosa in Patients with Cystic Fibrosis.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas aeruginosa Infection in Subjects with Cystic Fibrosis 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
INN or Proposed INN: AZTREONAM
Trade Name: TOBI®
INN or Proposed INN: TOBRAMYCIN
Other descriptive name: TOBRAMYCIN
Gilead Sciences, Inc.NULLNAFemale: yes
Male: yes
250Phase 3United States
60EUCTR2015-000396-26-Outside-EU/EEA
(EUCTR)
02/02/2015Program 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 ProgressionExpanded 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.NULLNAFemale: yes
Male: yes
603United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2011-001255-36-FR
(EUCTR)
14/10/2011Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-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.NULLNAFemale: yes
Male: yes
80Phase 2United States;France;Belgium;Spain;Poland;Ireland;Austria;Netherlands;Germany;Italy
62EUCTR2009-011740-19-Outside-EU/EEA
(EUCTR)
02/02/2015Clinical Trial to Assess the Safety and Efficacy of Aztreonam for Inhalation Solution (AZLI) in patients with Cystic Fibrosis (CF) and Chronic Burkholderia Species InfectionPhase 3b Randomized, Double-Blind, Placebo-Controlled Two-Part Trial to Assess the Safety and Efficacy of Continuous Aztreonam for Inhalation Solution (AZLI) in Subjects with Cystic Fibrosis (CF) and Chronic Burkholderia Species Infection Cystic Fibrosis subjects with chronic Burkholderia spp. infection of the airways.
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
Other descriptive name: N/A
Gilead Sciences, Inc.NULLNAFemale: yes
Male: yes
100Phase 3United States;Canada
63EUCTR2011-001362-18-FR
(EUCTR)
05/01/2012Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-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.NULLNAFemale: yes
Male: yes
60Phase 3United States;France;Spain;Poland;Germany;Italy