CompletedPhase 3

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

United States304 participantsStarted 2014-05-28

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Confirmed diagnosis of non-CF bronchiectasis * History of P. aeruginosa respiratory infections * At least two pulmonary exacerbations treated with antibiotics in the previous year Exclusion Criteria: * Have a clinical diagnosis of CF * Are pregnant

What they're measuring

Time to first pulmonary exacerbation (from baseline)

Timeframe: 48 weeks

Trial details

NCT IDNCT02104245

SponsorAradigm Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-08-11

View on ClinicalTrials.gov More Non Cystic Fibrosis Bronchiectasis trials