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Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI (PROAIR™ HFA (Albuterol Sulfate) Breath Actuated Inhalation Aerosol) in Pediatric Asthmatics

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Trial Profile

Chronic-Dose Safety and Efficacy Study of Albuterol-HFA-BAI (PROAIR™ HFA (Albuterol Sulfate) Breath Actuated Inhalation Aerosol) in Pediatric Asthmatics

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Apr 2022

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At a glance

  • Drugs Salbutamol (Primary)
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Sponsors Teva Branded Pharmaceutical Products R&D; Teva Pharmaceutical Industries

Most Recent Events

  • 31 Jan 2022 The primary endpoint has been changed from Observed efficacy up to two hours following dosing to Maximum Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Observed up to 2 Hours Following Completion of Dosing (FEV1max%0-2) at Day 22, according to ClinicalTrials.gov record.
  • 29 Apr 2016 The US FDA has approved ProAir RespiClick (albuterol sulfate) Inhalation Powder for the treatment or prevention of bronchospasm in children 4 to 11 years of age with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.
  • 30 Oct 2014 According to Teva Pharmaceutical Industries pipeline, company plans to submit an NDA to the FDA in 2015, based on the results of this study.

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