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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01313624

Public ClinicalTrials.gov record NCT01313624. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 12:47 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01313624
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Gilead Sciences
Industry
Enrollment
266 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 2011 (Type not available)
Primary completion
Mar 2013 (Actual)
Completion
Jun 2013 (Actual)
Last update posted
Apr 16, 2014

2011 – 2013

United States locations

U.S. sites
36
U.S. states
17
U.S. cities
32
Facility City State ZIP Site status
Pulmonary Associates Phoenix Arizona 85006 —
Arizona Pulmonary Specialists, LTD Phoenix Arizona 85012 —
St. Joseph's Hospital and Medical Center Heart and Lung Institute Phoenix Arizona 85013 —
Arizona Pulmonary Specialists Scottsdale Arizona 85258 —
David Geffen School of Medicine at UCLA Los Angeles California 90095 —
UC Davis Medical Center Division of Pulmonary, Critical Care and Sleep Medicine Sacramento California 95817 —
Landon Pediatric Foundation Ventura California 93003 —
National Jewish Health Denver Colorado 80202 —
University of Connecticut Health Center Farmington Connecticut 06030 —
Bay Area Chest Physicians Clearwater Florida 33756 —
University of Florida Gainesville Florida 32610 —
Pulmonary Disease Specialists (PDS) Research Kissimmee Florida 34741 —
University of Miami - Miller School of Medicine Miami Florida 33136 —
Central Florida Pulmonary Group Orlando Florida 32803 —
Cleveland Clinic Florida Weston Florida 33331 —
Atlanta Pulmonary Group Atlanta Georgia 30342 —
Pulmonary and Critical Care Associates of Baltimore Baltimore Maryland 21204 —
Mayo Clinic Rochester Minnesota 55905 —
Cardio Pulmonary Research at St. Luke's Hospital Chesterfield Missouri 63017 —
Albany Medical Center Albany New York 12208 —
Jamaica Hospital Medical Center Jamaica New York 11418 —
Winthrop University Hospital - Clinical Trials Center Mineola New York 11501 —
St. Luke's Roosevelt Hospital New York New York 10019 —
University of Cincinnati / UC Health Cincinnati Ohio 45267 —
Oregon Health and Science University Portland Oregon 97239 —
Drexel University College of Medicine Philadelphia Pennsylvania 19102 —
University of Pennsylvania Medical Center - Pulmonary, Allergy & Critical Care Division Philadelphia Pennsylvania 19104 —
Asthma Allergy & Pulmonary Associates Philadelphia Pennsylvania 19107 —
Medical University of South Carolina Charleston South Carolina 29425 —
Metroplex Pulmonary and Sleep Center McKinney Texas 75069 —
Alamo Clinical Research Associates San Antonio Texas 78212 —
University of Texas Health Science Center at Tyler Tyler Texas 75708 —
University of Virginia Pulmonary and Critical Care Charlottesville Virginia 22908 —
Inova Fairfax Hospital/ Heart and Vascular Institute Advanced Lung Disease and Transplant Center Falls Church Virginia 22042 —
Swedish Medical Center/Minor James Clinic Seattle Washington 98104 —
Multicare Pulmonary Specialist Tacoma Washington 98405 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 24 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01313624, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 16, 2014 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01313624 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →