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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
Methods A Comparison of the Efficacy of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler ® 160/4.5 mcg 1 Inhalation b.i.d. Plus as-Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults - a 26 Weeks, Randomised, Open-Label, Parallel-Group, Multicentre Study. July 2005 to December 2006
53 study locations in Chile, Croatia, Czech Republic, Greece, Iceland, Latvia, Lithuania, Portugal, Slovakia and Slovenia
Participants Age at least 12 years. Aim to enrol 1000 participants.
Inclusion Criteria: - - Diagnosis of asthma at least 3 months - Prescribed daily use of glucocorticosteroids at a dose > 320 mcg/ day for at least 3 months prior to Visit 1
Exclusion Criteria: - Smoking history > 10 pack-years - Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion - Any significant disease or disorder that may jeopardize the safety of the patient
Interventions The purpose of the study is to compare the efficacy of a flexible dose of Symbicort with conventional stepwise treatment according to asthma treatment guidelines in patients with persistent asthma

  1. Symbicort Turbuhaler® 160/4.5 mcg 1 Inhalation b.i.d. Plus as-Needed

  2. Conventional Best Practice
Outcomes Primary outcome:

  • Time to first severe asthma exacerbation

Secondary outcome:

  • Number of asthma exacerbations

  • Mean use of as-needed medication

  • Prescribed asthma medication

  • Asthma Control Questionnaire

  • Asthma related costs (direct asthma medication, direct non-medication costs and indirect costs)

Safety: Serious Adverse Events and discontinuations due to adverse eventsAll variables assessed over the 6 months treatment period
Definition of severe exacerbation
Not specified
Additional Data
Data on file from AstraZeneca indicates no patients with admission for asthma and 43 with at least one course of oral steroids (N=497) on SMART and 3/498 and 56/498 respectively on current best practice
Notes This study was completed in December 2006 but no results have yet been published in medical journals or on the AstraZeneca web site
Risk of bias
Item Authors’ judgement Description
Adequate sequence generation? Unclear No details
Allocation concealment? Unclear No details
Blinding?
All outcomes		 No Open
Incomplete outcome data addressed?
All outcomes		 Unclear No details