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A 52-week, double-blind, randomised, multi-centre, phase III, parallel-group study in patients 12 years and older with asthma, evaluating the efficacy and safety of Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 mcg as needed compared with Pulmicort (budesonide) Turbuhaler 200 mcg twice daily plus terbutaline Turbuhaler 0.4 mg as needed

Trial Profile

A 52-week, double-blind, randomised, multi-centre, phase III, parallel-group study in patients 12 years and older with asthma, evaluating the efficacy and safety of Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 mcg as needed compared with Pulmicort (budesonide) Turbuhaler 200 mcg twice daily plus terbutaline Turbuhaler 0.4 mg as needed

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2019

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At a glance

  • Drugs Budesonide/formoterol (Primary) ; Budesonide; Terbutaline
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Acronyms SYGMA 2
  • Sponsors AstraZeneca
  • Most Recent Events

    • 06 Nov 2019 Results of analysis of trial SYGMA 2 comparing budesonide/formoterol vs low-dose ICS maintenance therapy were presented at the 22nd Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research
    • 30 Sep 2019 According to an AstraZeneca Canada media release, based on positive results from the Phase III SYGMA 1 and 2 trials, the Health Canada has approved the expanded use of Symbicort Turbuhaler (budesonide/formoterol) for the treatment of mild persistent asthma in patients 12 years and older.Symbicort Turbuhaler is now approved as an anti-inflammatory reliever in Canada for use in mild persistent, moderate, or severe asthma patients.
    • 18 Sep 2018 Results published in the Annals of Internal Medicine
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