Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis "ORBIT-1"

Condition(s) targeted: Non-Cystic Fibrosis Bronchiectasis

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

Phase: Phase 2

Status: Recruiting

Sponsored by: Aradigm Corporation

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

Overall contact:
P. Bruinenberg, MBCHB MBA, Phone: +1-510-265-8838

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: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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.

P. Bruinenberg, MBCHB MBA, Phone: +1-510-265-8838

Berlin 13353, Germany; Recruiting

Donaustauf 93093, Germany; Recruiting

Heidelberg 69126, Germany; Recruiting

Neuwied 56564, Germany; Recruiting

Royal Brompton Hospital, London SW3 6NP, United Kingdom; Recruiting
Diana Bilton, MD, FRCP, Principal Investigator

Glasgow, "133 Balornock Road G21 3UW, United Kingdom; Recruiting

Birmingham, "1st Floor, Nuffield House B15 2TH, United Kingdom; Recruiting

Birmingham, "Bordesley Green East B9 5SS, United Kingdom; Recruiting

Bradford, "Duckworth Lane BD9 6RJ, United Kingdom; Recruiting

Belfast, "Ground Floor, Tower Block, Lisburn Road BT9 7AB, United Kingdom; Recruiting

Stoke on Trent, "Newcastle Road ST4 6QG, United Kingdom; Recruiting

Tyne and Wear, "Northumbria Healthcare NE29 8NH, United Kingdom; Recruiting

Manchester, "Southmoor Road M23 9LT, United Kingdom; Recruiting

Salford, "Stott Lane M6 8HD, United Kingdom; Recruiting

Calgary, Alberta T2N 1L9, Canada; Recruiting

Phoenix, Arizona 85006, United States; Recruiting

Kelowna, British Columbia V1Y 1E4, Canada; Recruiting

Vancouver, British Columbia V5Z 4E1, Canada; Recruiting

Vancouver, British Columbia V5Z 1M9, Canada; Recruiting

Los Angeles, California 90048, United States; Recruiting

Sacramento, California 95819, United States; Recruiting

Torrance, California 90505, United States; Recruiting

Waterbury, Connecticut 06708, United States; Recruiting

Brandon, Florida 33511, United States; Recruiting

Miami, Florida 33136, United States; Recruiting

Newcastle upon Tyne, Freeman Road, High Heaton NE7 7DN, United Kingdom; Recruiting

London, High Street Lewisham SE13 6LH, United Kingdom; Recruiting

Council Bluffs, Iowa 51503, United States; Recruiting

Summit, New Jersey 07901, United States; Recruiting

New York, New York 10016, United States; Recruiting

Elizabeth City, North Carolina 27909, United States; Recruiting

Toledo, Ohio 43614, United States; Recruiting

Ottawa, Ontario K1Y 4E9, Canada; Recruiting

Philadelphia, Pennsylvania 19104, United States; Recruiting

Montreal, Quebec H2W 1T8, Canada; Recruiting

St. Jerome, Quebec J7Z 5T3, Canada; Recruiting

McKinney, Texas 75069, United States; Recruiting

Starting date: February 2010
Last updated: August 17, 2010