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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 Oct 24, 2026, 4:15 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 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)

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) and lung infection due to Pseudomonas aeruginosa (PA).

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

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 2005 (Type not available)
Primary completion
Apr 2007 (Actual)
Completion
Apr 2007 (Actual)
Last update posted
Apr 21, 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 21, 2011 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00112359 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →