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A Single-Dose, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Five-Period Crossover, Dose-Ranging Efficacy and Safety Comparison of Albuterol Spiromax and ProAir HFA in Pediatric Patients With Persistent Asthma

Trial Profile

A Single-Dose, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Five-Period Crossover, Dose-Ranging Efficacy and Safety Comparison of Albuterol Spiromax and ProAir HFA in Pediatric Patients With Persistent Asthma

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 18 May 2016

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At a glance

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

    • 18 May 2016 Results presented at the 112th International Conference of the American Thoracic Society
    • 07 Mar 2016 Primary endpoint has been met. (Baseline-Adjusted Area-Under-The-Percent-Predicted Forced Expiratory Volume In 1 Second (FEV1) Versus Time Curve Over 6 Hours Post-Dose), according to results presented at the 2016 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.
    • 07 Mar 2016 Results presented at the 2016 Annual Meeting of the American Academy of Allergy, Asthma and Immunology
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