Clinical trial NCT01313624: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bronchiectasis
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2011-03-14
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in QOL-B Respiratory Symptoms Score at Day 28
timeFrame: Baseline to Day 28
Secondary outcomes:
measure: Change in QOL-B Respiratory Symptoms Score at Day 84
timeFrame: Baseline to Day 84
measure: Time to Protocol-Defined Exacerbation (PDE)
timeFrame: Baseline to Day 112
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pulmonary Associates
state: Arizona
city: Phoenix
country: United States
facility: Arizona Pulmonary Specialists, LTD
state: Arizona
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center Heart and Lung Institute
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Pulmonary Specialists
state: Arizona
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center Division of Pulmonary, Critical Care and Sleep Medicine
state: California
city: Ventura
country: United States
facility: Landon Pediatric Foundation
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Clearwater
country: United States
facility: Bay Area Chest Physicians
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Kissimmee
country: United States
facility: Pulmonary Disease Specialists (PDS) Research
state: Florida
city: Miami
country: United States
facility: University of Miami - Miller School of Medicine
state: Florida
city: Orlando
country: United States
facility: Central Florida Pulmonary Group
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Atlanta
country: United States
facility: Atlanta Pulmonary Group
state: Georgia
city: Baltimore
country: United States
facility: Pulmonary and Critical Care Associates of Baltimore
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Chesterfield
country: United States
facility: Cardio Pulmonary Research at St. Luke's Hospital
state: Missouri
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Jamaica
country: United States
facility: Jamaica Hospital Medical Center
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital - Clinical Trials Center
state: New York
city: New York
country: United States
facility: St. Luke's Roosevelt Hospital
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati / UC Health
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Medical Center - Pulmonary, Allergy & Critical Care Division
state: Pennsylvania
city: Philadelphia
country: United States
facility: Asthma Allergy & Pulmonary Associates
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: McKinney
country: United States
facility: Metroplex Pulmonary and Sleep Center
state: Texas
city: San Antonio
country: United States
facility: Alamo Clinical Research Associates
state: Texas
city: Tyler
country: United States
facility: University of Texas Health Science Center at Tyler
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Pulmonary and Critical Care
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital/ Heart and Vascular Institute Advanced Lung Disease and Transplant Center
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center/Minor James Clinic
state: Washington
city: Tacoma
country: United States
facility: Multicare Pulmonary Specialist
state: Washington
city: Concord
country: Australia
facility: Concord Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital
state: New South Wales
city: Glebe
country: Australia
facility: Woolcock Institute of Medical Research
state: New South Wales
city: Kogarah
country: Australia
facility: St. George Hospital
state: New South Wales
city: Perth
country: Australia
facility: Royal Perth Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Mater Adult Hospital
state: Queensland
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royla Adelaide Hospital
state: South Australia
city: Daws Park
country: Australia
facility: Repatriation General Hospital
state: South Australia
city: Toorak Gardens
country: Australia
facility: Respiratory Clinical Trials
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Frankston
country: Australia
facility: Peninsula Health
state: Victoria
city: Westmead
country: Australia
facility: Alfred Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Kelowna
country: Canada
facility: Kelowna Respiratory and Allergy Clinic
state: British Columbia
city: Vancouver
country: Canada
facility: The Lung Centre at Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital Pacific Lung Research
state: British Columbia
city: Kingston
country: Canada
facility: Kingston General Hospital / Queen's University
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Windsor
country: Canada
facility: Dr. Anil Dhar Private Practice
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de L'Université de Montréal Hotel Dieu
state: Quebec
Study officials:
affiliation: Oregon Health and Science University
name: Alan Barker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barker AF, O'Donnell AE, Flume P, Thompson PJ, Ruzi JD, de Gracia J, Boersma WG, De Soyza A, Shao L, Zhang J, Haas L, Lewis SA, Leitzinger S, Montgomery AB, McKevitt MT, Gossage D, Quittner AL, O'Riordan TG. Aztreonam for inhalation solution in patients with non-cystic fibrosis bronchiectasis (AIR-BX1 and AIR-BX2): two randomised double-blind, placebo-controlled phase 3 trials. Lancet Respir Med. 2014 Sep;2(9):738-49. doi: 10.1016/S2213-2600(14)70165-1. Epub 2014 Aug 18.