Status:
COMPLETED
Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis "ORBIT-1"
Lead Sponsor:
Aradigm Corporation
Conditions:
Non-Cystic Fibrosis Bronchiectasis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Are willing and able to provide written informed consent.
- Are males or females 18 to 80 year of age, inclusive.
- Have had a confirmed diagnosis of non-CF bronchiectasis per high resolution computed tomography (HRCT) for at least 4 years.
- Confirmation of infection with P. aeruginosa at screening
Exclusion
- Have a known local or systemic hypersensitivity to fluoroquinolone or quinolone antibiotics.
- Have an exacerbation during the Screening Phase as defined as requiring treatment with inhaled, oral, or intravenous antibiotics prior to the first dose of study drug.
- Have a diagnosis of cystic fibrosis..
- Have had changes in either the treatment regimen or initiation of treatment with any of the following medications within 28 days prior to Visit 1:
- Azithromycin
- Hypertonic saline
- Bronchodilator medications
- Oral corticosteroid.
- Have received an investigational drug or device within 28 days prior to Visit 1.
- Have any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patients' treatment, assessment, or compliance with the protocol.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00889967
Start Date
February 1 2010
End Date
June 1 2011
Last Update
January 25 2017
Active Locations (37)
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1
Phoenix, Arizona, United States, 85006
2
Los Angeles, California, United States, 90048
3
Sacramento, California, United States, 95819
4
Torrance, California, United States, 90505