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

NCT00712166 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2010-12-20

Study results available
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Summary

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.

Conditions

Interventions

DRUG

AZLI 75 mg three times daily (TID)

DRUG

Placebo three times daily (TID)

Sponsors & Collaborators

Principal Investigators

  • Claire Wainwright, MD · Royal Children's Hospital, Brisbane, QLD, Australia

  • Ron Gibson, MD · Children's Hospital & Regional Medical Center, Seattle WA, USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-06-30
Completion
2009-08-31

Countries

  • United States
  • Australia
  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00712166 on ClinicalTrials.gov