At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 61 enrolled
Drug / intervention
AZLIdrug
Likely dose
AZLI 75 mgfrom 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.
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
In Brief
A Phase 3 clinical trial evaluating AZLI for Cystic Fibrosis and Pseudomonas Aeruginosa. Completed, enrolled 61 participants across 29 sites in 6 countries.
Detailed Summary
This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three 28-day courses of Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily, each followed by 28 days off AZLI. The total treatment duration was to be 6 months.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis, Pseudomonas Aeruginosa
CountriesFrance, Germany, Italy, Poland, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 2011
Enrollment StartDec 2011
Primary CompletionApr 2013
TodayJul 2026
First PostedJul 28, 2011
Enrollment StartDec 1, 2011
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.9 years ago
Interventions
AZLIdrug
AZLI 75 mg was administered 3 times daily via the investigational nebulizer.