Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis

Brief Title

Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis

Official Title

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

Brief Summary

      The AIR-BX1 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and
      gram-negative airway infection. Participants received two 28-day courses of either Aztreonam
      for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a
      28-day off-drug period. Following the two blinded courses, all participants received a 28-day
      course of open-label AZLI then were followed for an additional 56 days.
    

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Change in QOL-B Respiratory Symptoms Score at Day 28

Secondary Outcome

 Change in QOL-B Respiratory Symptoms Score at Day 84

Condition

Bronchiectasis

Intervention

AZLI

Study Arms / Comparison Groups

 AZLI-AZLI

Description:  Participants were randomized to receive blinded AZLI for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI for 28 days plus 56 days of treatment-free follow-up.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

266

Start Date

April 2011

Completion Date

June 2013

Primary Completion Date

March 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Male/Female 18 years or older with non-CF bronchiectasis

          -  Chronic sputum production on most days

          -  Positive sputum culture for gram-negative organisms

          -  Must have met lung function requirements

        Exclusion Criteria:

          -  History of CF

          -  Hospitalized within 14 days prior to joining the study

          -  Previous exposure to AZLI

          -  Pregnant, breastfeeding, or unwilling to follow contraceptive measures for the study

          -  Must have met liver and kidney function requirements

          -  Continuous oxygen use of greater than 2 liters per minute (supplemental oxygen with
             activity and at night was allowed)

          -  Treatment for nontuberculous mycobacteria infection or active mycobacterium
             tuberculosis infection within 1 year of enrollment

          -  Other serious medical conditions.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Alan Barker, MD, , 

Location Countries

Australia

Location Countries

Australia

NCT ID

NCT01313624

Organization ID

GS-US-219-0101

Responsible Party

Sponsor

Study Sponsor

Gilead Sciences

Study Sponsor

Alan Barker, MD, Principal Investigator, Oregon Health and Science University

Verification Date

March 2014