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A Clinical Study Comparing Symbicort 'as Needed' With Terbutaline 'as Needed' and With Pulmicort Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma

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Trial Profile

A Clinical Study Comparing Symbicort 'as Needed' With Terbutaline 'as Needed' and With Pulmicort Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jan 2022

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At a glance

  • Drugs Budesonide/formoterol (Primary) ; Budesonide; Terbutaline
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Acronyms SYGMA1
  • Sponsors AstraZeneca

    • Most Recent Events

    • 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.
    • 14 Feb 2020 According to an AstraZeneca Canada media release, based on positive results from the Phase III SYGMA 1 and 2 trials, the company made a regulatory submission in China for Symbicort for the treatment of mild asthma in December 2019.

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