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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: NCT01314716

Public ClinicalTrials.gov record NCT01314716. 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 22, 2026, 1:49 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/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2)

Brief summary

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

The AIR-BX2 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
NCT01314716
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Gilead Sciences
Industry
Enrollment
274 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
Apr 2013 (Actual)
Completion
Jul 2013 (Actual)
Last update posted
Apr 16, 2014

2011 – 2013

United States locations

U.S. sites
33
U.S. states
19
U.S. cities
33
Facility City State ZIP Site status
Florence Research Associates Florence Alabama 35630 —
Clinical Trials Connection Flagstaff Arizona 86001 —
Phoenix Medical Group Peoria Arizona 85381 —
Pulmonary Associates Phoenix Arizona 85006 —
AZ Pulmonary Specialists, LTD Scottsdale Arizona 85258 —
Pulmonary Consultants & Primary Care Physicians Medical Group, Inc. Orange California 92780 —
UC San Diego Medical Center San Diego California 92103 —
California Pacific Medical Center San Francisco California 94115 —
Georgetown University Hospital Washington D.C. District of Columbia 20007 —
University of Florida Jacksonville Florida 32209 —
University of Miami Miller School of Medicine Miami Florida 33136 —
Central Florida Pulmonary Group Orlando Florida 32803 —
Sarasota Memorial Hospital - Clinical Research Center Sarasota Florida 34239 —
Pasadena Center for Medical Research St. Petersburg Florida 33707 —
Tampa General Hospital - New Lung Associates Tampa Florida 33606 —
Florida Premier Research Institute Winter Park Florida 32789 —
Southeastern Lung Care PC Decatur Georgia 30033 —
University of Chicago Medical Center Chicago Illinois 60637 —
Loess Hills Clinical Research Council Bluffs Iowa 51503 —
Kentuckiana Pulmonary Associates Louisville Kentucky 40202 —
Pulmonary & Critical Care Associates of Baltimore Rosedale Maryland 21237 —
Robert Wood Johnson Medical School New Brunswick New Jersey 08903 —
Pulmonary & Allergy Associates, P.A. Summit New Jersey 07901 —
Jamaica Hospital Medical Center Jamaica New York 11418 —
Columbia University, NY Presbyterian Hospital New York New York 10032 —
UNC Chapel Hill Chapel Hill North Carolina 27599 —
The Oregon Clinic P.C./ Pulmonary Division Portland Oregon 97220 —
University of Pennsylvania Medical Center Philadelphia Pennsylvania 19104 —
University of Texas Health Science Center at Tyler Tyler Texas 75708 —
University of Utah Salt Lake City Utah 84132 —
Pulmonary Consultants, PLLC Tacoma Washington 98405 —
University of Wisconsin Hospital and Clinics Madison Wisconsin 53792 —
Medical College of Wisconsin Froedtert Hospital Milwaukee Wisconsin 53226 —

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 52 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01314716, 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 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01314716 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →