Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis "ORBIT-1"
NCT00889967 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95
Last updated 2017-01-25
Summary
The purpose of this study is to evaluate the safety and efficacy of Ciprofloxacin for Inhalation in the treatment of patients with non-cystic fibrosis (CF) bronchiectasis.
Conditions
- Non-Cystic Fibrosis Bronchiectasis
Interventions
- DRUG
-
Ciprofloxacin for Inhalation
100 mg once daily by inhalation for 28 days
- DRUG
-
Ciprofloxacin for Inhalation
150 mg once daily by inhalation for 28 days
- DRUG
-
Placebo once daily by inhalation for 28 days
Sponsors & Collaborators
-
Aradigm Corporation
lead INDUSTRY
Principal Investigators
-
Paul Bruinenberg, MBChB, MBA · Aradigm Corporation
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-02-28
- Primary Completion
- 2011-04-30
- Completion
- 2011-06-30
Countries
- United States
- Canada
- Germany
- United Kingdom
Study Locations
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