Conditions: Cystic Fibrosis Pseudomonas Aeruginosa
Keywords: Cystic fibrosis CF PA Pseudomonas aeruginosa AZLI aztreonam Chronic Pseudomonas aeruginosa
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 61
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment.

Interventions: intervention 1: AZLI
Intervention descriptions: intervention 1: AZLI 75 mg was administered 3 times daily via the investigational nebulizer.

Protocol document: