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A Study to See if AZLI (an Inhaled Antibiotic) is Effective in Treating Adults With Non-CF Bronchiectasis - AIR-BX1


A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX1)




The AIR-BX-1 study is for people who have been diagnosed with non-CF bronchiectasis and have gram-negative airway infection. This is a randomized study, the participants will be selected by chance (like flipping a coin) to receive one of two treatments (AZLI or Placebo). This is a double-blind study which means participants and their study doctors will not know what treatment they are assigned to receive. Participants will receive two 28-day courses of either AZLI or placebo taken 3 times a day. Each course has a 28 day off-drug period. Following the two blinded courses, all participants will receive AZLI for the third 28-day course. Based on observed safety and effectiveness of AZLI in the adult CF population, and due to the similarities in the lung diseases for patients with CF and non-CF bronchiectasis, AZLI represents a potential treatment option for people with non-CF bronchiectasis and infection of the airways.

Study Status: Completed


Condition Intervention Phase
Bronchiectasis Drug: Aztreonam for Inhalation Solution (AZLI)
Drug: Placebo
Phase 3

Verified by Gilead Sciences August, 2012

Sponsored by: Gilead Sciences
Information provided by: Gilead Sciences identifier: NCT01313624

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Cleveland Clinic Florida
Weston, Florida 33331
United States

Alan Barker, MD., Principal Investigator

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