Study:
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)
Rationale:
n/a
Purpose:
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: Active, not recruiting
Recruiting:
n/a
| 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
ClinicalTrials.gov 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