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

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-Cystic Fibrosis Bronchiectasis

In brief

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.

Key facts

Study ID

NCT00889967

Run by

Aradigm Corporation

People needed

95

Starts

2010-02-01

Expected to finish

2011-06-01

Last updated by the study team

2017-01-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Are willing and able to provide written informed consent.
• Are males or females 18 to 80 year of age, inclusive.
• Have had a confirmed diagnosis of non-CF bronchiectasis per high resolution computed tomography (HRCT) for at least 4 years.
• Confirmation of infection with P. aeruginosa at screening

You may not qualify if…

• Have a known local or systemic hypersensitivity to fluoroquinolone or quinolone antibiotics.
• 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.
• Have a diagnosis of cystic fibrosis..
• 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.
• Have received an investigational drug or device within 28 days prior to Visit 1.
• 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.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — Sacramento, California, United States
• Study site — Torrance, California, United States
• Study site — Waterbury, Connecticut, United States
• Study site — Brandon, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Council Bluffs, Iowa, United States
• Study site — Summit, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Elizabeth City, North Carolina, United States
• Study site — Toledo, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — McKinney, Texas, United States
• Study site — Calgary, Alberta, Canada
• Study site — Kelowna, British Columbia, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Ottawa, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Saint-Jérôme, Quebec, Canada
• Study site — Berlin, Germany
• Study site — Donaustauf, Germany
• Study site — Heidelberg, Germany
• Study site — Neuwied, Germany

Full record on ClinicalTrials.gov

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