Non-Cystic Fibrosis Bronchiectasis
Conditions
Keywords
Pseudomonas aeruginosa, antimicrobial, inhalation, ciprofloxacin, Non-Cystic Fibrosis Bronchiectasis
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.
Interventions
DRUGCiprofloxacin for Inhalation
100 mg once daily by inhalation for 28 days
DRUGPlacebo
Placebo once daily by inhalation for 28 days
Sponsors
Aradigm Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is defined as the mean change in P. aeruginosa density in sputum (log10) CFU/gram of sputum from Baseline to Day 28. | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Microbiological efficacy | 28 days |
| Time to, number of, severity of, and time to resolve exacerbations | 28 days |
| Changes in spirometry 4. Quality of life (QOL) 5. Safety and tolerability | 28 days |
| Quality of life (QOL) | 28 days |
| Safety and tolerability | 28 days |
Countries
Canada, Germany, United Kingdom, United States
Outcome results
None listed