NCT01404234

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis
• Pseudomonas Aeruginosa

Interventions

Type	Name	Description
DRUG	AZLI	AZLI 75 mg was administered 3 times daily via the investigational nebulizer.

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2011-07-28
• Last updated: 2014-05-29
• Results posted: 2014-05-01

Locations

29 sites across 6 countries: United States, France, Germany, Italy, Poland, Spain