299. Cystic fibrosis
1,592 clinical trials,   1,539 drugs   (DrugBank: 255 drugs),   81 drug target genes,   162 drug target pathways

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"
15 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2013-005366-19-FR
(EUCTR)
19/05/201522/06/2015A Multi-centre, Randomised, Double-Blind, Placebo-Controlled Study to evaulate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Coprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to the non-cystic fibrosis bronchiectasisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4) Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis
MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Germany;Netherlands;New Zealand
2EUCTR2013-005348-28-PL
(EUCTR)
11/02/201526/11/2014A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis. This study includes a 28-day open label extension (all patients will receive study drug for the last 28 days of the study).A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis.
MedDRA version: 19.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 19.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Ireland;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;South Africa;Latvia;Germany
3EUCTR2013-005366-19-PL
(EUCTR)
11/02/201526/11/2014A Multi-centre, Randomised, Double-Blind, Placebo-Controlled Study to evaulate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Coprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to the non-cystic fibrosis bronchiectasis. The study includes a 28-day open-label extension (all patients will receive study drug for the last 28 days of the study).A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4) Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis
MedDRA version: 19.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 19.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3Serbia;United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Georgia;Germany;New Zealand
4EUCTR2013-005348-28-IE
(EUCTR)
07/11/201411/09/2014A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis. This study includes a 28-day open-label extension (all patients will receive study drug for the last 28 days of the study).A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis.
MedDRA version: 19.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 19.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Ireland;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;South Africa;Germany;Latvia
5EUCTR2013-005366-19-RO
(EUCTR)
30/07/201430/05/2014A Multi-centre, Randomised, Double-Blind, Placebo-Controlled Study to evaulate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Coprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to the non-cystic fibrosis bronchiectasisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4) Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis
MedDRA version: 17.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 17.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255United States;Spain;Israel;United Kingdom;Italy;Hungary;Canada;Poland;Romania;Australia;South Africa;Georgia;Netherlands;Germany;Latvia;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2013-005348-28-RO
(EUCTR)
30/07/201430/05/2014A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis.
MedDRA version: 17.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 17.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255United States;Spain;Ireland;Israel;United Kingdom;Italy;Hungary;Canada;Poland;Romania;Australia;South Africa;Georgia;Netherlands;Germany;Latvia;New Zealand
7EUCTR2013-005348-28-LV
(EUCTR)
28/07/201408/05/2014A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis. This study includes a 28-day open-label extension (all patients will receive study drug for the last 28 days of the study).A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis.
MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Ireland;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;South Africa;Latvia;Germany;New Zealand
8EUCTR2013-005366-19-ES
(EUCTR)
17/06/201411/04/2014A multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Pulmaquin®(ARD-3150, dual reléase ciprofloxacin for inhalation)in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with non-cystic fibrosis bronchiectasis (ORBIT 4) Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis
MedDRA version: 16.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 100000004862
MedDRA version: 16.1;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: ciprofloxacin hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Australia;Netherlands;Germany;New Zealand
9EUCTR2013-005348-28-ES
(EUCTR)
16/06/201411/04/2014A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis.
MedDRA version: 17.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 17.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Ireland;Israel;United Kingdom;Italy;Hungary;Canada;Poland;Romania;Australia;Latvia;Germany;Netherlands;New Zealand
10EUCTR2013-005348-28-IT
(EUCTR)
22/05/201424/03/2014A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis.
MedDRA version: 16.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 100000004862
MedDRA version: 16.1;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Ireland;Israel;Italy;United Kingdom;Hungary;Canada;Poland;Romania;Australia;Latvia;Netherlands;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2013-005366-19-IT
(EUCTR)
22/05/201427/03/2014A Multi-centre, Randomised, Double-Blind, Placebo-Controlled Study to evaulate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Coprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to the non-cystic fibrosis bronchiectasisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4) Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis
MedDRA version: 16.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 100000004862
MedDRA version: 16.1;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Australia;Netherlands;Germany;New Zealand
12EUCTR2013-005366-19-HU
(EUCTR)
08/05/201421/03/2014A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis. This study includes a 28-day open-label extension (all patients will receive study drug for the last 28 days of the study).A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis.
MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255Serbia;United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Georgia;Germany;New Zealand
13EUCTR2013-005348-28-HU
(EUCTR)
06/05/201421/03/2014A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis. This study includes a 28-day open-label extension (all patients will receive study drug for the last 28 days of the study).A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis.
MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
255United States;Spain;Ireland;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;South Africa;Germany;Latvia
14EUCTR2013-005348-28-GB
(EUCTR)
06/05/201412/03/2014A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis. This study includes a 28-day open-label extension (all patients will receive study drug for the last 28 days of the study).A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis.
MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Ireland;Israel;United Kingdom;Italy;Hungary;Canada;Poland;Romania;Australia;South Africa;Germany;Latvia
15EUCTR2013-005366-19-GB
(EUCTR)
29/04/201417/03/2014A Multi-centre, Randomised, Double-Blind, Placebo-Controlled Study to evaulate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Coprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to the non-cystic fibrosis bronchiectasisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections withPseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4) Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis
MedDRA version: 16.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 100000004862
MedDRA version: 16.1;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Netherlands;Germany;New Zealand