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Completed Phase 3 Interventional Results available

Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa

ClinicalTrials.gov ID: NCT00712166

Public ClinicalTrials.gov record NCT00712166. 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, 4:40 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 Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine For Inhalation in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa (AIR-CF4)

Brief summary

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

The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung disease (forced expiratory volume in 1 second \[FEV1\] \>75% predicted, and Pseudomonas aeruginosa (PA) infection.

Study identification

NCT ID
NCT00712166
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Gilead Sciences
Industry
Enrollment
160 participants

Conditions and interventions

Eligibility (public fields only)

Age range
6 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
May 2008 (Type not available)
Primary completion
Jun 2009 (Actual)
Completion
Aug 2009 (Actual)
Last update posted
Dec 20, 2010

2008 – 2009

United States locations

U.S. sites
34
U.S. states
19
U.S. cities
29
Facility City State ZIP Site status
Phoenix Children's Hospital Phoenix Arizona — —
University Medical Center Tucson Arizona — —
Arkansas Children's Hospital Little Rock Arkansas — —
University of Arkansas for Medical Sciences, Division of Pulmonary and Critical Care Medicine Little Rock Arkansas — —
Kaiser Permanente Oakland California — —
Children's Hospital of Orange County Orange California — —
The Children's Hospital Aurora Colorado — —
Connecticut Children's Medical Center Hartford Connecticut — —
Nemours Children's Clinic Jacksonville Florida — —
Nemours Children's Clinic Orlando Florida — —
Children's Memorial Hospital Chicago Illinois — —
Indiana University, Outpatient Clinical Research Facility Indianapolis Indiana — —
James Whitcomb Riley Hospital for Children Indianapolis Indiana — —
Children's Hospital, Boston Boston Massachusetts — —
Tufts Medical Center, Pediatric Pulmonary Clinic Boston Massachusetts — —
University of Michigan Health System Ann Arbor Michigan — —
The Children's Hospital of Michigan, Detroit Medical Center Detroit Michigan — —
The Minnesota CF Center, University of Minnesota Medical Center Minneapolis Minnesota — —
Children's Lung Specialists Las Vegas Nevada — —
Albany Medical College Albany New York — —
The Lung & Cystic Fibrosis Center, University of Buffalo Pediatric Associates, Inc., Women & Children's Hospital of Buffalo Buffalo New York — —
Long Island Jewish Medical Center New Hyde Park New York — —
SUNY Upstate Medical University Syracuse New York — —
Cincinnati Children's Hospital Medical Center Cincinnati Ohio — —
Nationwide Children's Hospital Columbus Ohio — —
Toledo Children's Hospital/Toledo Hospital, Cystic Fibrosis Research Center Toledo Ohio — —
Santiago Reyes, MD Oklahoma City Oklahoma — —
Penn State Milton S. Hershey Medical Center Hershey Pennsylvania — —
Drexel University College of Medicine, Pulmonary Associates Philadelphia Pennsylvania — —
Penn Presbyterian Medical Center Philadelphia Pennsylvania — —
St. Christopher's Hospital for Children Philadelphia Pennsylvania — —
Baylor College of Medicine Houston Texas — —
Primary Children's Medical Center Salt Lake City Utah — —
Children's Hospital and Regional Medical Center Seattle Washington — —

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 6 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00712166, 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 Dec 20, 2010 · 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 NCT00712166 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →