Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects With Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas Aeruginosa (PA) Infection/Colonization
Phase of Trial: Phase III
Latest Information Update: 16 Jan 2019
At a glance
- Drugs Aztreonam (Primary)
- Indications Cystic fibrosis-associated respiratory tract infections
- Focus Registrational; Therapeutic Use
- Acronyms ALPINE2
- Sponsors Gilead Sciences
- 10 Dec 2017 This trial has been completed in Ireland.
- 03 Aug 2017 Status changed from not yet recruiting to recruiting.
- 20 Jul 2017 New trial record