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

Aradigm Corporation278 enrolled

Overview

This study (ARD-3150-1201, ORBIT-3) 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

278

Conditions

Non Cystic Fibrosis Bronchiectasis

Interventions

Ciprofloxacin dispersion for inhalationDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Verified bronchiectasis diagnosis * Pseudomonas aeruginosa lung infection Exclusion Criteria: * Cystic Fibrosis

Locations (109)

Outcomes

Primary Outcomes

Time to first exacerbation

Time frame: One Year

Secondary Outcomes

Number of exacerbations

Time frame: One Year

Data from ClinicalTrials.gov

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Peoria, Arizona, United States

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Phoenix, Arizona, United States

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Downey, California, United States

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Los Angeles, California, United States

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Poway, California, United States

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Farmington, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Celebration, Florida, United States

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Kissimmee, Florida, United States

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Miami, Florida, United States

...and 99 more locations