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 Information
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
Administrative Informations
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