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
Latest Information Update: 13 Apr 2022
At a glance
- Drugs Aztreonam (Primary)
- Indications Cystic fibrosis-associated respiratory tract infections; Pseudomonal infections
- Focus Registrational; Therapeutic Use
- Acronyms ALPINE 2
- Sponsors Gilead Sciences
- 02 Mar 2022 Status changed from completed to discontinued by sponsor due to the challenges and risks introduced by Coronavirus disease 2019 (COVID-19) pandemic.
- 20 Oct 2021 Status changed from active, no longer recruiting to completed.
- 08 Oct 2021 This trial has been completed in Austria, Germany and Denmark (End Date: 23 Sep 2021), according to European Clinical Trials Database record.