Overview
Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis "ORBIT-1"
Status:
Completed
Completed
Trial end date:
2011-06-01
2011-06-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Aradigm CorporationTreatments:
Ciprofloxacin
Criteria
Inclusion Criteria:1. Are willing and able to provide written informed consent.
2. Are males or females 18 to 80 year of age, inclusive.
3. Have had a confirmed diagnosis of non-CF bronchiectasis per high resolution computed
tomography (HRCT) for at least 4 years.
4. Confirmation of infection with P. aeruginosa at screening
Exclusion Criteria:
1. Have a known local or systemic hypersensitivity to fluoroquinolone or quinolone
antibiotics.
2. 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.
3. Have a diagnosis of cystic fibrosis..
4. 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.
5. Have received an investigational drug or device within 28 days prior to Visit 1.
6. 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.