Bayq3939    (DrugBank: -)

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30

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.
30 / 1,592 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02555059
(ClinicalTrials.gov)
July 15, 201618/9/2015Special Drug Use Investigation of Ciproxan Injection in PediatricsSpecial Drug Use Investigation of Ciproxan® Injection in PediatricsCystitis / Pyelonephritis / Cystic Fibrosis / AnthraxDrug: Cipro (Ciprofloxacin, BAYQ3939)BayerNULLCompletedN/A14 YearsAll48Japan
2NCT02661438
(ClinicalTrials.gov)
January 12, 201630/12/2015Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using PlaceboMulticenter Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation in Subjects With Non-Cystic Fibrosis Bronchiectasis (NCFB) or Chronic Obstructive Pulmonary Disease (COPD) Using Matching PlaceboBronchiectasis;Pulmonary Disease, Chronic ObstructiveDrug: Placebo to Ciprofloxacin DPI (BAYQ3939)BayerNovartisCompleted40 YearsN/AAll46N/AUnited States
3EUCTR2013-004659-19-SK
(EUCTR)
15/12/201406/10/2014Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 non-CF bronchiectasis
MedDRA version: 20.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Ciprofloxacin DPI
Product Code: BAYQ3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer Healthcare AG, D-51368 Leverkusen, GermanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
492Phase 3United States;Portugal;Serbia;Philippines;Taiwan;Hong Kong;Slovakia;Thailand;Russian Federation;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany
4EUCTR2011-004208-39-SK
(EUCTR)
18/11/201421/10/2014Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 bronchiectasis
MedDRA version: 18.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Australia;Denmark;Germany;Latvia;New Zealand;Japan
5EUCTR2011-004208-39-LV
(EUCTR)
11/11/201426/09/2014Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 bronchiectasis
MedDRA version: 17.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
400Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Australia;Denmark;Latvia;Germany;New Zealand;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2013-004659-19-LV
(EUCTR)
11/11/201430/09/2014Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 non-CF bronchiectasis
MedDRA version: 17.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Ciprofloxacin DPI
Product Code: BAYQ3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer Healthcare AG, D-51368 Leverkusen, GermanyNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany
7EUCTR2013-004659-19-BG
(EUCTR)
26/09/201405/08/2014Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 non-CF bronchiectasis
MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Ciprofloxacin DPI
Product Code: BAYQ3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
492Phase 3Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany
8EUCTR2013-004659-19-PT
(EUCTR)
02/09/201403/07/2014Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 non-CF bronchiectasis
MedDRA version: 19.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYQ3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer Healthcare AG, D-51368 Leverkusen, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Phase 3United States;Portugal;Taiwan;Hong Kong;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;New Zealand
9EUCTR2013-004659-19-CZ
(EUCTR)
27/08/201420/05/2014Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 non-CF bronchiectasis
MedDRA version: 20.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYQ3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
492Phase 3United States;Portugal;Taiwan;Hong Kong;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;New Zealand
10EUCTR2013-004659-19-AT
(EUCTR)
17/06/201413/05/2014Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 non-CF bronchiectasis
MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYQ3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
492Phase 3Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2013-004659-19-LT
(EUCTR)
12/05/201420/03/2014Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 non-CF bronchiectasis
MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYQ3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
492Phase 3Serbia;Portugal;United States;Hong Kong;Taiwan;Slovakia;Thailand;Lithuania;Turkey;Austria;Russian Federation;Czech Republic;Argentina;Poland;Brazil;Romania;Australia;South Africa;Bulgaria;Netherlands;Latvia;Germany;China;Korea, Republic of
12NCT02106832
(ClinicalTrials.gov)
April 30, 20144/4/2014Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.BronchiectasisDrug: Ciprofloxacin (BAYQ3939) dry powder for inhalation;Drug: PlaceboBayerNovartisCompleted18 YearsN/AAll521Phase 3United States;Argentina;Australia;Austria;Brazil;Bulgaria;China;Czechia;Germany;Hong Kong;Korea, Republic of;Latvia;Lithuania;Netherlands;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Taiwan;Thailand;Turkey;Czech Republic
13EUCTR2013-004659-19-DE
(EUCTR)
23/04/201403/02/2014Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 non-CF bronchiectasis
MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Ciprofloxacin DPI
Product Code: BAYQ3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
492Phase 3Serbia;United States;Portugal;Philippines;Taiwan;Hong Kong;Slovakia;Thailand;Russian Federation;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Argentina;Brazil;Poland;Romania;Bulgaria;Germany;New Zealand
14EUCTR2013-004659-19-NL
(EUCTR)
23/04/201427/02/2014Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 non-CF bronchiectasis
MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Ciprofloxacin DPI
Product Code: BAYQ3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
492Phase 3Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Slovakia;Thailand;Russian Federation;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany
15NCT01764841
(ClinicalTrials.gov)
May 2, 20138/1/2013Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.BronchiectasisDrug: Ciprofloxacin DPI (BAYQ3939);Drug: PlaceboBayerNovartisCompleted18 YearsN/AAll416Phase 3United States;Argentina;Australia;Denmark;France;Germany;Israel;Italy;Japan;Latvia;New Zealand;Slovakia;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2011-004208-39-FR
(EUCTR)
22/03/201327/06/2013Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 bronchiectasis
MedDRA version: 16.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3Slovakia;Spain;Israel;United Kingdom;Italy;France;United States;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan
17EUCTR2011-004208-39-DK
(EUCTR)
12/03/201317/12/2012Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 bronchiectasis
MedDRA version: 17.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
400Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Brazil;Denmark;Australia;Latvia;Germany;New Zealand;Japan
18EUCTR2011-004208-39-ES
(EUCTR)
29/01/201326/11/2012Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non-CF BE)Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non-cystic fibrosis bronchiectasis. - RESPIRE 1 bronchiectasis
MedDRA version: 14.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan
19EUCTR2011-004208-39-DE
(EUCTR)
21/01/201323/10/2012Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 bronchiectasis
MedDRA version: 18.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan
20EUCTR2011-004208-39-IT
(EUCTR)
11/01/201311/12/2012Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 bronchiectasis
MedDRA version: 14.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYq3939
INN or Proposed INN: CIPROFLOXACIN
BAYER HEALTHCARE AGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2009-009869-34-SE
(EUCTR)
12/10/200929/07/2009Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939 Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of > 35 % and < 80 percent of predicted)
MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis
MedDRA version: 9.1;Level: PT;Term: Bronchiectasis
Product Name: Cipro Inhale
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
122United Kingdom;Germany;Spain;Sweden
22EUCTR2009-009869-34-GB
(EUCTR)
02/09/200909/04/2009Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939 Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of > 35 % and < 80 percent of predicted)
MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis
MedDRA version: 9.1;Level: PT;Term: Bronchiectasis
Product Name: Cipro Inhale
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
122Germany;United Kingdom;Spain;Sweden
23NCT00910351
(ClinicalTrials.gov)
July 200928/5/2009Cipro Inhaler for Cystic Fibrosis Children Ages 6-12A Study to Evaluate the Safety and Pharmacokinetics of Ciprofloxacin in Adults and Children Aged 6 - 12 Years With Cystic Fibrosis Following Inhalation of Ciprofloxacin Dry PowderPseudomonas InfectionDrug: Ciprofloxacin (Cipro, BAYQ3939)BayerNULLCompleted6 Years12 YearsBoth19Phase 1United States
24EUCTR2008-008314-40-DE
(EUCTR)
22/06/200903/03/2009Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosisRandomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis Cystic fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Ciprofloxacin Inhale
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Product Name: Ciprofloxacin Inhale
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
276Denmark;Germany;United Kingdom;Sweden
25EUCTR2009-009869-34-DE
(EUCTR)
08/06/200917/03/2009Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939 Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of > 35 % and < 80 percent of predicted)
MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis
MedDRA version: 9.1;Level: PT;Term: Bronchiectasis
Product Name: Cipro Inhale
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
122Spain;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2008-008314-40-DK
(EUCTR)
02/06/200916/04/2009Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosisRandomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis Cystic fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Ciprofloxacin Inhale
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Product Name: Ciprofloxacin Inhale
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
276United Kingdom;Germany;Denmark;Sweden
27NCT00930982
(ClinicalTrials.gov)
June 200930/6/2009Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis BronchiectasisRandomized, Placebo-controlled, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of Ciprofloxacin Inhale Compared to Placebo in Patients With Non-cystic Fibrosis BronchiectasisBronchiectasisDrug: Ciprofloxacin (Cipro, BAYQ3939);Drug: PlaceboBayerNovartisCompleted18 YearsN/AAll124Phase 2United States;Australia;Germany;Spain;Sweden;United Kingdom
28EUCTR2008-008314-40-GB
(EUCTR)
18/05/200909/04/2009Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosisRandomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis Cystic fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Ciprofloxacin Inhale
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Product Name: Ciprofloxacin Inhale
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Bayer Healthcare AGNULLNot RecruitingFemale: yes
Male: yes
276Germany;United Kingdom;Denmark;Sweden
29EUCTR2008-008314-40-SE
(EUCTR)
15/05/200925/03/2009Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosisRandomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis Cystic fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Ciprofloxacin Inhale
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Product Name: Ciprofloxacin Inhale
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
276United Kingdom;Germany;Denmark;Sweden
30NCT00645788
(ClinicalTrials.gov)
May 200826/3/2008Study to Evaluate the Safety and Efficacy of Ciprofloxacin (Inhaled) in Patients With Cystic FibrosisRandomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Inhaled Ciprofloxacin Compared to Placebo in Subjects With Cystic FibrosisCystic FibrosisDrug: Ciprofloxacin (Cipro Inhale, BAYQ3939);Drug: PlaceboBayerNovartisCompleted12 YearsN/AAll288Phase 2United States;Australia;Canada;Denmark;Germany;Israel;Norway;Sweden;United Kingdom