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

Bronchiectasis Clinical Trial

— AIR-BX1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01313624
• Other study ID #: GS-US-219-0101
• Status: Completed
• Phase: Phase 3
• First received: March 10, 2011
• Last updated: March 7, 2014
• Start date: April 2011
• Est. completion date: June 2013

Study information

• Verified date: March 2014
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: June 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Drug:
• AZLI
AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily
• Placebo
Placebo to match AZLI administered via nebulizer three times daily

Locations

Country	Name	City	State
Australia	Royla Adelaide Hospital	Adelaide	South Australia
Australia	Mater Adult Hospital	Brisbane	Queensland
Australia	The Prince Charles Hospital	Chermside	Queensland
Australia	Monash Medical Centre	Clayton	Victoria
Australia	Concord Hospital	Concord	New South Wales
Australia	St. Vincent's Hospital	Darlinghurst	New South Wales
Australia	Repatriation General Hospital	Daws Park	South Australia
Australia	Peninsula Health	Frankston	Victoria
Australia	Woolcock Institute of Medical Research	Glebe	New South Wales
Australia	St. George Hospital	Kogarah	New South Wales
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Royal Perth Hospital	Perth	New South Wales
Australia	Respiratory Clinical Trials	Toorak Gardens	South Australia
Australia	Alfred Hospital	Westmead	Victoria
Australia	Westmead Hospital	Westmead	New South Wales
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Kelowna Respiratory and Allergy Clinic	Kelowna	British Columbia
Canada	Kingston General Hospital / Queen's University	Kingston	Ontario
Canada	Centre Hospitalier de L'Université de Montréal Hotel Dieu	Montreal	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	St. Paul's Hospital Pacific Lung Research	Vancouver	British Columbia
Canada	The Lung Centre at Vancouver General Hospital	Vancouver	British Columbia
Canada	Dr. Anil Dhar Private Practice	Windsor	Ontario
United States	Albany Medical Center	Albany	New York
United States	Atlanta Pulmonary Group	Atlanta	Georgia
United States	Pulmonary and Critical Care Associates of Baltimore	Baltimore	Maryland
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia Pulmonary and Critical Care	Charlottesville	Virginia
United States	Cardio Pulmonary Research at St. Luke's Hospital	Chesterfield	Missouri
United States	University of Cincinnati / UC Health	Cincinnati	Ohio
United States	Bay Area Chest Physicians	Clearwater	Florida
United States	National Jewish Health	Denver	Colorado
United States	Inova Fairfax Hospital/ Heart and Vascular Institute Advanced Lung Disease and Transplant Center	Falls Church	Virginia
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	University of Florida	Gainesville	Florida
United States	Jamaica Hospital Medical Center	Jamaica	New York
United States	Pulmonary Disease Specialists (PDS) Research	Kissimmee	Florida
United States	David Geffen School of Medicine at UCLA	Los Angeles	California
United States	Metroplex Pulmonary and Sleep Center	McKinney	Texas
United States	University of Miami - Miller School of Medicine	Miami	Florida
United States	Winthrop University Hospital - Clinical Trials Center	Mineola	New York
United States	St. Luke's Roosevelt Hospital	New York	New York
United States	Central Florida Pulmonary Group	Orlando	Florida
United States	Asthma Allergy & Pulmonary Associates	Philadelphia	Pennsylvania
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	University of Pennsylvania Medical Center - Pulmonary, Allergy & Critical Care Division	Philadelphia	Pennsylvania
United States	Arizona Pulmonary Specialists, LTD	Phoenix	Arizona
United States	Pulmonary Associates	Phoenix	Arizona
United States	St. Joseph's Hospital and Medical Center Heart and Lung Institute	Phoenix	Arizona
United States	Oregon Health and Science University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	UC Davis Medical Center Division of Pulmonary, Critical Care and Sleep Medicine	Sacramento	California
United States	Alamo Clinical Research Associates	San Antonio	Texas
United States	Arizona Pulmonary Specialists	Scottsdale	Arizona
United States	Swedish Medical Center/Minor James Clinic	Seattle	Washington
United States	Multicare Pulmonary Specialist	Tacoma	Washington
United States	University of Texas Health Science Center at Tyler	Tyler	Texas
United States	Landon Pediatric Foundation	Ventura	California
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in QOL-B Respiratory Symptoms Score at 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	No
Secondary	Change in QOL-B Respiratory Symptoms Score at 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	No
Secondary	Time to Protocol-Defined Exacerbation (PDE)	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	No