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
Price :
$35
*
At a glance
- Drugs Budesonide/formoterol (Primary) ; Budesonide; Terbutaline
- Indications Asthma
- Focus Registrational; Therapeutic Use
- Acronyms SYGMA 2
- Sponsors AstraZeneca
- 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.