Clinical Trials

Toll-Free: 866.320.4573

Call Us Toll Free:

866.223.2273 x1234

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

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: Completed

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

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.

Cleveland Clinic Mobile Site