Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis

Condition(s) targeted: Non-Cystic Fibrosis Bronchiectasis

Intervention: Ciprofloxacin for Inhalation (Drug); Ciprofloxacin for Inhalation (Drug); Placebo (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Aradigm Corporation

Official(s) and/or principal investigator(s):
Paul Bruinenberg, MBChB, MBA, Study Director, Affiliation: Aradigm Corporation

Overall contact:
Diana Bilton, MD, FRCP, Phone: +44 (0)20 7352 8121

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.

Official title: An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared With Placebo for Inhalation in the Management of Pseudomonas Aeruginosa in Patients With Non Cystic Fibrosis Bronchiectasis

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome:

Microbiological efficacy

Time to, number of, severity of, and time to resolve exacerbations

Changes in spirometry 4. Quality of life (QOL) 5. Safety and tolerability

Quality of life (QOL)

Safety and tolerability

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Diana Bilton, MD, FRCP, Phone: +44 (0)20 7352 8121

Royal Brompton Hospital, London SW3 6NP, United Kingdom

Starting date: August 2009
Last updated: April 28, 2009