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Completed Phase 3 Interventional Results available

Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower Airways

ClinicalTrials.gov ID: NCT01404234

Public ClinicalTrials.gov record NCT01404234. 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 21, 2026, 11:52 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

Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa (PA) in the Lower Airways

Study identification

NCT ID
NCT01404234
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Gilead Sciences
Industry
Enrollment
61 participants

Conditions and interventions

Interventions

  • AZLI Drug

Drug

Eligibility (public fields only)

Age range
Up to 12 Years
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
Nov 30, 2011
Primary completion
Mar 31, 2013
Completion
Mar 31, 2013
Last update posted
May 28, 2014

2011 – 2013

United States locations

U.S. sites
10
U.S. states
10
U.S. cities
10
Facility City State ZIP Site status
The Children's Hospital - Denver Aurora Colorado 80045
Nemours Children's Clinic - Jacksonville Jacksonville Florida 32207
Children's Memorial Hospital Chicago Illinois 60614
Riley Hospital for Children Indianapolis Indiana 46202
Children's Hospital Boston Boston Massachusetts 02115
Children's Mercy Hospital & Clinics Kansas City Missouri 64108
SUNY Upstate Medical University Syracuse New York 13210
Nationwide Children's Hospital Columbus Ohio 43205
Baylor College of Medicine Houston Texas 77030
University of Utah Salt Lake City Utah 84108

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 19 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01404234, 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 May 28, 2014 · Synced Jul 21, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01404234 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →