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"
20 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-003399-58-DK
(EUCTR)
14/01/201707/01/2016Can antibiotic treatment improve the prognosis of Pseudomonas aeruginosa infected patients with chronic pulmonary obstructive disease, non-cystic fibrosis bronchiectasis and asthma?Target-ABC (Targeted AntiBiotics for Chronic pulmonary disease):Can targeted antibiotic therapy improve the prognosis of Pseudomonas aeruginosa infected patients with chronic pulmonary obstructive disease, non-cystic fibrosis bronchiectasis and asthma? - Target-ABC (Targetted AntiBiotics for Chronic pulmonary disease) Respiratory tract infection Bacterial infection with Pseudomonas aeruginosaChronic obstructive pulmonary disease (COPD)Non-cystic fibrosis bronchiectasisAsthma
MedDRA version: 20.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Ciprofloxacin
INN or Proposed INN: ciprofloxacin hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE
Product Name: Piperacillin/Tazobactam
INN or Proposed INN: piperacillin sodium , tazobactam sodium
Other descriptive name: PIPERACILLIN SODIUM
COP:TRIN Region Hovedstaden (Gentofte hospital)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4Denmark
2EUCTR2016-001785-29-IE
(EUCTR)
15/08/201610/05/2016Study of the effects of combined treatment with the CFTR corrector ivacaftor and IV antibiotics on infection in CF.Combined Effect of CFTR Modifiers and Intensive Antibiotic Treatment Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Kalydeco
INN or Proposed INN: IVACAFTOR
Trade Name: Ciprofloxacin
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE
Product Name: Flucloxicillin
INN or Proposed INN: FLUCLOXACILLIN SODIUM
Trade Name: Fortum
INN or Proposed INN: CEFTAZIDIME
Product Name: Tobramycin
INN or Proposed INN: TOBRAMYCIN SULFATE
Trade Name: Meropenem
INN or Proposed INN: Meropenem
Other descriptive name: MEROPENEM
Trade Name: Colistin
INN or Proposed INN: COLISTIMETHATE SODIUM
St. Vincent's University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Ireland
3EUCTR2013-005366-19-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
4EUCTR2013-005366-19-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
5EUCTR2013-005348-28-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
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-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
7EUCTR2013-005348-28-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
8EUCTR2013-005366-19-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
9EUCTR2013-005348-28-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
10EUCTR2013-005366-19-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2013-005348-28-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
12EUCTR2013-005348-28-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
13EUCTR2013-005366-19-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
14EUCTR2013-005366-19-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
15EUCTR2013-005348-28-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2013-005348-28-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
17EUCTR2013-005366-19-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
18EUCTR2011-006171-19-IT
(EUCTR)
27/10/201113/01/2012Multicentric and randomized study to evaluate the effectiveness of the association of the 2 different treatments in the early P.aerugionsa infection in patient with cystic fibrosis disease. The study will enlist pazients over 5 years old.randomized multicentric clinical trial upon efficacy of two different drugs combination to eradication of early p.aeruginosa infection in cystic fibrosis patients over 5 years old. Cystic fibrosis patients with early P.aeruginosa infection.
MedDRA version: 14.1;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: CIPROXIN*6CPR RIV 500MG
INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE
Trade Name: BRAMITOB*NEBUL 56F 300MG/4ML
INN or Proposed INN: TOBRAMYCIN
Trade Name: CIPROXIN*6CPR RIV 500MG
INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE
Trade Name: PROMIXIN*NEBUL 30MONOD 1MUI
INN or Proposed INN: COLISTIN MESILATE SODIUM
AZIENDA OSPEDALIERA MEYERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
19EUCTR2009-014412-35-GB
(EUCTR)
23/02/201001/10/2009An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/AAn International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/A Non-cystic fibrosis bronchiectasis
MedDRA version: 12.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS
Product Name: Ciprofloxacin for Inhalation
Product Code: None assigned
INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Germany;United Kingdom
20EUCTR2009-014412-35-DE
(EUCTR)
27/01/201009/10/2009An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/AAn International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/A Non-cystic fibrosis bronchiectasis
MedDRA version: 12.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS
Product Name: Ciprofloxacin for Inhalation
Product Code: None assigned
INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
96Phase 2Germany;United Kingdom