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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

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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: 11 May 2022

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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

  • 01 May 2022 Results of sub analysis (n=579) of Russian population published in the Journal of Asthma
  • 26 Jan 2021 According to an AstraZeneca media release, Symbicort Turbuhaler has been approved as an anti-inflammatory reliever taken as-needed in mild asthma in 35 countries, and regulatory reviews are ongoing in additional countries.
  • 26 Jan 2021 According to an AstraZeneca media release, based on the results from SYGMA 1 and 2 studies, Symbicort Turbuhaler (budesonide/formoterol 160/4.5mcg) has been approved in China by the National Medical Products Administration (NMPA) as an anti-inflammatory reliever to be taken as-needed in response to symptoms to achieve asthma control in patients with mild asthma aged 12 years and older.

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