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. Author manuscript; available in PMC: 2014 Jun 12.
Published in final edited form as: Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007313. doi: 10.1002/14651858.CD007313.pub2
Trial name or title SYMPHONIE
Methods A Comparison of Symbicort Single Inhaler and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults. A 26-Week, Randomised, Open, Parallel Group Multicentre Study.
Estimated enrolment: 1000
Participants Inclusion Criteria:
  • Age 12 years and older

  • Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition. Prescribed inhaled GCS at a dose of 3400 μg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1.


Exclusion Criteria:
  • Use of any beta-blocking agent, including eye-drops, Use of oral GCS as maintenance treatment, A history of smoking 3 10 pack years (1 pack year = 1 pack (20 cigarettes) per day for one year or equivalent).

Interventions A flexible dose of Symbicort compared with conventional stepwise treatment according to asthma treatment guidelines in patients with persistent asthma
Outcomes Primary Outcome Measures: Time to first severe asthma exacerbation

Secondary Outcome Measures: Number of asthma exacerbations, Mean use of as-needed medication, Prescribed asthma medication, Asthma Control Questionnaire, Satisfaction with Asthma Treatment Questionnaire, Safety: Serious Adverse Events and discontinuations due to adverse events
Starting date Sept 2005
Contact information
Notes