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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00112359

Public ClinicalTrials.gov record NCT00112359. 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 23, 2026, 11:58 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, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary Pseudomonas Aeruginosa (AIR-CF1)

Study identification

NCT ID
NCT00112359
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Gilead Sciences
Industry
Enrollment
166 participants

Conditions and interventions

Interventions

  • AZLI 75 mg three times a day (TID) Drug
  • Placebo three times a day (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, 2005
Primary completion
Mar 31, 2007
Completion
Mar 31, 2007
Last update posted
Apr 20, 2011

2005 – 2007

United States locations

U.S. sites
40
U.S. states
29
U.S. cities
40
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama
Pediatric Breathing Disorders Clinic Anchorage Alaska
Phoenix Children's Hospital Phoenix Arizona
University of Arkansas for Medical Sciences Little Rock Arkansas
Miller Children's Hospital Long Beach California
Children's Hospital, Los Angeles Los Angeles California
Children's Hospital of Orange County Orange California
Capital Allergy and Respiratory Disease Center Sacramento California
Yale New Haven Hospital New Haven Connecticut
University of Florida Health Sciences Center Gainesville Florida
Nemours Children's Clinic, Orlando Orlando Florida
Medical College of Georgia Augusta Georgia
Children's Memorial Hospital / Northwestern University Chicago Illinois
Riley Hospital for Children Indianapolis Indiana
University of Iowa Iowa City Iowa
Via Christi - St. Francis Regional Medical Center Wichita Kansas
Tulane University Health Sciences Center New Orleans Louisiana
Louisiana State University Health Sciences Center Shreveport Louisiana
Central Maine Pulmonary Associates Auburn Maine
University of Michigan Ann Arbor Michigan
University of Mississippi Medical Center Jackson Mississippi
University of Missouri Columbia Missouri
St. Louis University St Louis Missouri
Children's Lung Specialists Las Vegas Nevada
St. Barnabas Healthcare System Livingston New Jersey
Albany Medical College Albany New York
Long Island Jewish Medical Center New Hyde Park New York
SUNY Upstate Medical University Syracuse New York
University of North Carolina Chapel Hill North Carolina
Cincinnati Children's Hospital Medical Center Cincinnati Ohio
University of Pennsylvania Health System Philadelphia Pennsylvania
Children's Hospital of Pittsburgh Pittsburgh Pennsylvania
Pediatric Pulmonary Associates, South Carolina Columbia South Carolina
Baylor Martha Foster Lung Care Center Dallas Texas
Alamo Clinical Research Associates San Antonio Texas
University of Utah Salt Lake City Utah
Naval Medical Center Portsmouth Virginia
Pediatric Pulmonary Center/Virginia Commonwealth University Richmond Virginia
University of Washington Medical Center Seattle Washington
University of Wisconsin Madison Wisconsin

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 13 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00112359, 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 20, 2011 · Synced Jul 23, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00112359 live on ClinicalTrials.gov.

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