Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)

Completed · Phase 3 · Has a placebo group

Conditions studied: Non Cystic Fibrosis Bronchiectasis

In brief

This study (ARD-3150-1202, ORBIT-4) will evaluate the safety and efficacy of inhaled Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history of pulmonary exacerbations and chronic P. aeruginosa infections.

Key facts

Study ID

NCT02104245

Run by

Aradigm Corporation

People needed

304

Starts

2014-05-28

Expected to finish

2016-10-01

Last updated by the study team

2021-03-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of non-CF bronchiectasis
• History of P. aeruginosa respiratory infections
• At least two pulmonary exacerbations treated with antibiotics in the previous year

You may not qualify if…

• Have a clinical diagnosis of CF
• Are pregnant

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Torrance, California, United States
• Study site — Danbury, Connecticut, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Decatur, Georgia, United States
• Study site — Duluth, Georgia, United States
• Study site — Port Huron, Michigan, United States
• Study site — Omaha, Nebraska, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — Summit, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Columbus, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Rock Hill, South Carolina, United States
• Study site — Spartanburg, South Carolina, United States
• Study site — Tyler, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Milwaukee, Wisconsin, United States
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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