Phase 3 Study to Evaluate the Chronic-dose Safety and Efficacy of Albuterol-HFA-MDI Relative to Placebo in Pediatric Asthmatics.

Trial Profile

Phase 3 Study to Evaluate the Chronic-dose Safety and Efficacy of Albuterol-HFA-MDI Relative to Placebo in Pediatric Asthmatics.

Completed
Phase of Trial: Phase III

Latest Information Update: 27 Oct 2016

At a glance

  • Drugs Salbutamol (Primary)
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Sponsors Teva Pharmaceutical Industries
  • Most Recent Events

    • 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.
    • 05 Aug 2008 The expected study completion date has changed from May 2008 to Jul 2008 as reported by ClinicalTrials.gov.
    • 05 Aug 2008 Patient number amended from 100 to 104, as reported by ClinicalTrials.gov.
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