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

Aradigm Corporation304 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

304

Conditions

Non Cystic Fibrosis Bronchiectasis

Interventions

Ciprofloxacin dispersion for inhalationDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (95)

Outcomes

Primary Outcomes

Time to first pulmonary exacerbation (from baseline)

Time frame: 48 weeks

Data from ClinicalTrials.gov

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Sacramento, California, United States

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San Diego, California, United States

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Torrance, California, United States

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Danbury, Connecticut, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Winter Park, Florida, United States

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Decatur, Georgia, United States

...and 85 more locations