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

Information source: Aradigm Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-Cystic Fibrosis Bronchiectasis

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

Phase: Phase 2

Status: Completed

Sponsored by: Aradigm Corporation

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

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.

Clinical Details

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, 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

Eligibility

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.

Locations and Contacts

Berlin 13353, Germany

Donaustauf 93093, Germany

Heidelberg 69126, Germany

Neuwied 56564, Germany

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

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

Royal Brompton Hospital, London SW3 6NP, United Kingdom

"Stott Lane, Salford M6 8HD, United Kingdom

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

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

Calgary, Alberta T2N 1L9, Canada

Phoenix, Arizona 85006, United States

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

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

"Duckworth Lane,, Bradford, Britain BD9 6RJ, United Kingdom

"Southmoor Road, M23 9LT, Manchester, Britain, United Kingdom

Kelowna, British Columbia V1Y 1E4, Canada

Vancouver, British Columbia V5Z 1M9, Canada

Vancouver, British Columbia V5Z 4E1, Canada

Los Angeles, California 90048, United States

Sacramento, California 95819, United States

Torrance, California 90505, United States

Waterbury, Connecticut 06708, United States

Brandon, Florida 33511, United States

Miami, Florida 33136, United States

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

London, High Street Lewisham SE13 6LH, United Kingdom

Council Bluffs, Iowa 51503, United States

Summit, New Jersey 07901, United States

New York, New York 10016, United States

Elizabeth City, North Carolina 27909, United States

Toledo, Ohio 43614, United States

Ottawa, Ontario K1Y 4E9, Canada

Philadelphia, Pennsylvania 19104, United States

Montreal, Quebec H2W 1T8, Canada

St. Jerome, Quebec J7Z 5T3, Canada

McKinney, Texas 75069, United States

Additional Information

Starting date: February 2010
Last updated: August 27, 2012

Page last updated: August 23, 2015

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