Trial document
This study has been imported from ClinicalTrials.gov without additional data checks.
DRKS00007335
Trial Description
Title
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.
Trial Acronym
RESPIRE 2
URL of the Trial
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Brief Summary in Lay Language
The purpose of this study is to evaluate if the time to first pulmonary exacerbation of
bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days
every other 28 days or for 14 days every other 14 days over 48 weeks.
Brief Summary in Scientific Language
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Description IPD sharing plan:
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Organizational Data
- DRKS00007335
- 2016/03/04
- 2014/04/04
- no
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Secondary IDs
- 2013-004659-19
- NCT02106832 (ClinicalTrials.gov)
- 15626 (Bayer)
- 2013-004659-19
Health Condition or Problem studied
- Bronchiectasis
- J47 - Bronchiectasis
Interventions/Observational Groups
- Drug: Ciprofloxacin: administered for 28 days on / 28 days off
- Drug: Placebo: administered for 28 days on / 28 days off
- Drug: Ciprofloxacin: administered for 14 days on / 14 days off
- Drug: Placebo: administered for 14 days on / 14 days off
Characteristics
- Interventional
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- Randomized controlled trial
- Blinded
- patient/subject, caregiver, investigator/therapist, assessor
- Placebo
- Treatment
- Parallel
- III
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Primary Outcome
- Time to first exacerbation; time frame: over 48 weeks after baseline; Description: Exacerbation is defined by signs and symptoms plus intervention with systemic antibiotics
Secondary Outcome
- Mean number of exacerbations per patient per 48 weeks; time frame: over 48 weeks after baseline; Description: Exacerbation is defined by signs and symptoms plus intervention with systemic antibiotics
- Pathogens present at baseline and eradicated at 48 weeks; time frame: Baseline and 48 weeks
- Quality of Life: Changes of Saint George's Respiratory; time frame: Baseline and 48 weeks
- New pathogens at 48 weeks, not present at baseline; time frame: Baseline and 48 weeks
- Changes of Forced Expiratory Volume in 1 second from baseline; time frame: Baseline and 48 weeks
- Number of participants with Adverse events as a measure of; time frame: up to 58 weeks after screening
Countries of Recruitment
- United States
- Argentina
- Australia
- Austria
- Brazil
- Bulgaria
- China
- Czech Republic
- Germany
- Hong Kong
- Korea, Republic of
- Latvia
- Lithuania
- Netherlands
- Poland
- Portugal
- Romania
- Russian Federation
- South Africa
- Taiwan, Province of China
- Thailand
- Turkey
Locations of Recruitment
Recruitment
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- 2014/04/30
- 300
- Multicenter trial
- International
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
- Patients with a proven and documented diagnosis of non CF idiopathic or post
infectious bronchiectasis
- Stable pulmonary status and stable regimen of standard treatment at least for the
past 4 weeks
Exclusion Criteria
- Forced expiratory volume in 1 second (FEV1) <30% or >90% predicted
- Active allergic bronchopulmonary aspergillosis
- Active and actively treated non tuberculosis mycobacterial (NTM) infection or
tuberculosis
- Primary diagnosis of Chronic obstructive pulmonary disease (COPD)
Addresses
-
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- Bayer
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- Novartis
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- Bayer
- Bayer Study Director
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- Bayer Clinical Trials Contact
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- clinical-trials-contact at bayerhealthcare.com
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Sources of Monetary or Material Support
-
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- Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
- Click here and search for drug information provided by the FDA.
- Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
- 1
- 2014/11/05