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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

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Trial Profile

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

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 13 Apr 2022

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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
  • Most Recent Events

    • 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.

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