A 26 Week, Randomized, Double-blind, Parallel-group, Active Controlled, Multicenter, Multinational Safety Study Evaluating the Risk of Serious Asthma-related Events During Treatment With Symbicort, a Fixed Combination of Inhaled Corticosteroid (ICS) (Budesonide) and a Long Acting beta2-agonist (LABA) (Formoterol) as Compared to Treatment With ICS (Budesonide) Alone in Adult and Adolescent (>=12 Years of Age) Patients With Asthma.

Trial Profile

A 26 Week, Randomized, Double-blind, Parallel-group, Active Controlled, Multicenter, Multinational Safety Study Evaluating the Risk of Serious Asthma-related Events During Treatment With Symbicort, a Fixed Combination of Inhaled Corticosteroid (ICS) (Budesonide) and a Long Acting beta2-agonist (LABA) (Formoterol) as Compared to Treatment With ICS (Budesonide) Alone in Adult and Adolescent (>=12 Years of Age) Patients With Asthma.

Completed
Phase of Trial: Phase III/IV

Latest Information Update: 20 Dec 2016

At a glance

  • Drugs Budesonide/formoterol (Primary) ; Budesonide
  • Indications Asthma
  • Focus Therapeutic Use
  • Sponsors AstraZeneca
  • Most Recent Events

    • 31 Aug 2016 According to an AstraZeneca media release, results from this study were published in The New England Journal of Medicine.
    • 31 Aug 2016 Primary endpoint has been met. (Time to first event included in the definition of asthma exacerbation), as reported in an AstraZeneca media release.
    • 31 Aug 2016 Results published in the Media Release
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