Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis (AIR-BX1)

March 7, 2014 updated by: Gilead Sciences

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

266

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Concord Hospital
      • Darlinghurst, New South Wales, Australia, 2010
        • St. Vincent's Hospital
      • Glebe, New South Wales, Australia, 2037
        • Woolcock Institute of Medical Research
      • Kogarah, New South Wales, Australia, 2217
        • St. George Hospital
      • Perth, New South Wales, Australia, 6000
        • Royal Perth Hospital
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4101
        • Mater Adult Hospital
      • Chermside, Queensland, Australia, 4032
        • The Prince Charles Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royla Adelaide Hospital
      • Daws Park, South Australia, Australia, 5041
        • Repatriation General Hospital
      • Toorak Gardens, South Australia, Australia, 5065
        • Respiratory Clinical Trials
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Frankston, Victoria, Australia, 3199
        • Peninsula Health
      • Westmead, Victoria, Australia, 3194
        • Alfred Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • University of Calgary
      • Edmonton, Alberta, Canada, T6G 2C8
        • University of Alberta
    • British Columbia
      • Kelowna, British Columbia, Canada, V1W 1V3
        • Kelowna Respiratory and Allergy Clinic
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • The Lung Centre at Vancouver General Hospital
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital Pacific Lung Research
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V6
        • Kingston General Hospital / Queen's University
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital
      • Windsor, Ontario, Canada, N8X 5A6
        • Dr. Anil Dhar Private Practice
    • Quebec
      • Montreal, Quebec, Canada, H2W 1T8
        • Centre Hospitalier de L'Université de Montréal Hotel Dieu
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Pulmonary Associates
      • Phoenix, Arizona, United States, 85012
        • Arizona Pulmonary Specialists, Ltd
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital and Medical Center Heart and Lung Institute
      • Scottsdale, Arizona, United States, 85258
        • Arizona Pulmonary Specialists
    • California
      • Los Angeles, California, United States, 90095
        • David Geffen School of Medicine at UCLA
      • Sacramento, California, United States, 95817
        • UC Davis Medical Center Division of Pulmonary, Critical Care and Sleep Medicine
      • Ventura, California, United States, 93003
        • Landon Pediatric Foundation
    • Colorado
      • Denver, Colorado, United States, 80202
        • National Jewish Health
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • University of Connecticut Health Center
    • Florida
      • Clearwater, Florida, United States, 33756
        • Bay Area Chest Physicians
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Kissimmee, Florida, United States, 34741
        • Pulmonary Disease Specialists (PDS) Research
      • Miami, Florida, United States, 33136
        • University of Miami - Miller School of Medicine
      • Orlando, Florida, United States, 32803
        • Central Florida Pulmonary Group
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Pulmonary Group
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Pulmonary and Critical Care Associates of Baltimore
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Cardio Pulmonary Research at St. Luke's Hospital
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • Jamaica, New York, United States, 11418
        • Jamaica Hospital Medical Center
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital - Clinical Trials Center
      • New York, New York, United States, 10019
        • St. Luke's Roosevelt Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati / UC Health
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University College of Medicine
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Medical Center - Pulmonary, Allergy & Critical Care Division
      • Philadelphia, Pennsylvania, United States, 19107
        • Asthma Allergy & Pulmonary Associates
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Texas
      • McKinney, Texas, United States, 75069
        • Metroplex Pulmonary and Sleep Center
      • San Antonio, Texas, United States, 78212
        • Alamo Clinical Research Associates
      • Tyler, Texas, United States, 75708
        • University of Texas Health Science Center at Tyler
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Pulmonary and Critical Care
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital/ Heart and Vascular Institute Advanced Lung Disease and Transplant Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center/Minor James Clinic
      • Tacoma, Washington, United States, 98405
        • Multicare Pulmonary Specialist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AZLI-AZLI
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.
AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily
Placebo Comparator: Placebo-AZLI
Participants were randomized to receive blinded placebo to match 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.
AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily
Placebo to match AZLI administered via nebulizer three times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in QOL-B Respiratory Symptoms Score at Day 28
Time Frame: Baseline to Day 28
The mean (SD) change in the Respiratory Symptoms score on the Quality of Life Questionnaire-Bronchiectasis (QOL-B) was measured from baseline to the end of Course 1 (Day 28). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.
Baseline to Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in QOL-B Respiratory Symptoms Score at Day 84
Time Frame: Baseline to Day 84
The mean (SD) change in the Respiratory Symptoms score on the QOL-B was measured from baseline to the end of Course 2 (Day 84). The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.
Baseline to Day 84
Time to Protocol-Defined Exacerbation (PDE)
Time Frame: Baseline to Day 112

Protocol-defined exacerbation was defined as an acute worsening of respiratory disease that triggered the initiation of a non-study antibiotic meeting at least 3 major criteria, or 2 major and at least 2 minor criteria.

  • Major Criteria: increased sputum production; increased discoloration of sputum; increased dyspnea; increased cough
  • Minor Criteria: fever (> 38º C) measured during clinic visit; increased malaise or fatigue; forced expiratory volume in 1 second (FEV1) (L) or forced vital capacity (FVC) decreased > 10% from baseline; new or increased hemoptysis
Baseline to Day 112

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 10, 2011

First Submitted That Met QC Criteria

March 11, 2011

First Posted (Estimate)

March 14, 2011

Study Record Updates

Last Update Posted (Estimate)

April 16, 2014

Last Update Submitted That Met QC Criteria

March 7, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • GS-US-219-0101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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