Ciprofloxacin for Inhalation ( DrugBank: Ciprofloxacin )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
299嚢胞性線維症12

299. 嚢胞性線維症


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
No.TrialIDDate_
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PhaseCountries
1EUCTR2013-005348-28-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
2EUCTR2013-005348-28-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
3EUCTR2013-005348-28-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 CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Ireland;Israel;United Kingdom;Italy;Hungary;Canada;Poland;Romania;Australia;Georgia;South Africa;Germany;Latvia;Netherlands;New Zealand
4EUCTR2013-005348-28-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
5EUCTR2013-005366-19-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
6EUCTR2013-005348-28-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
7EUCTR2013-005348-28-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
8EUCTR2013-005348-28-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
9NCT01090908
(ClinicalTrials.gov)
September 201011/3/2010Evaluation of Ciprofloxacin for Inhalation to Cystic Fibrosis Patients With P. AeruginosaA Multi-Center, Open Label Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Ciprofloxacin For Inhalation (CFI) Given Daily For 14 Days To Stable Cystic Fibrosis Patients Ages 6 To 17 With Pseudomonas AeruginosaCystic FibrosisDrug: AntibioticAradigm CorporationNULLWithdrawn6 Years18 YearsBoth0N/ANULL
10EUCTR2009-014412-35-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
11NCT00889967
(ClinicalTrials.gov)
February 201027/4/2009Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis ORBIT-1An 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 BronchiectasisNon-Cystic Fibrosis BronchiectasisDrug: Ciprofloxacin for Inhalation;Drug: PlaceboAradigm CorporationNULLCompleted18 Years80 YearsAll95Phase 2United States;Canada;Germany;United Kingdom
12EUCTR2009-014412-35-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