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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 Jul 20, 2026, 7:12 PM 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)

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

Interventions

  • AZLI 75 mg three times daily (TID) Drug
  • Placebo three times daily (TID) Drug

Drug

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
Apr 30, 2008
Primary completion
May 31, 2009
Completion
Jul 31, 2009
Last update posted
Dec 19, 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 19, 2010 · Synced Jul 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00712166 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →