At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 160 enrolled
Drug / intervention
AZLI 75 mg three times daily (TID) +1 moredrug
Likely dose
AZLI 75 mg three times daily (TID)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating AZLI 75 mg three times daily (TID) and Placebo three times daily (TID) for Cystic Fibrosis and 2 related conditions. Completed, enrolled 160 participants across 40 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis, Lung Infection, Pseudomonas Aeruginosa
CountriesAustralia, Canada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2008
First PostedJul 2008
Primary CompletionJun 2009
Study CompletionAug 2009
TodayJul 2026
First PostedJul 9, 2008
Enrollment StartMay 1, 2008
Primary CompletionJun 1, 2009
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.0 years ago
Interventions
AZLI 75 mg three times daily (TID)drug
Placebo three times daily (TID)drug