STYLE.

Methods	A comparison of the efficacy of Symbicort SiT (Symbicort Turbuhaler® 160/4.5 µg 1 inhalation b.i.d. plus as‐needed) and conventional best practice for the treatment of persistent asthma in adolescents and adults ‐ a 26‐week, 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. 1008 participants enrolled (986 analysed for safety). Inclusion Criteria: ‐ ‐ Diagnosis of asthma at least 3 months ‐ Prescribed daily use of glucocorticosteroids at a dose > 320 µg/ 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 Symbicort Turbuhaler® 160/4.5 µg 1 inhalation b.i.d. plus as‐needed 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: SAEs and discontinuations due to AEs. All variables assessed over the 6‐month 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. A trial report (published in 2008 on the AstraZeneca web site) has been used for the 2013 update.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Randomization code assigned from a computer generated randomisation schedule" Demoly 2009
Allocation concealment (selection bias)	Low risk	"Patients were randomised, strictly sequentially...using coded envelopes. When a patient had been randomised, the envelope was opened and the code was revealed." Demoly 2009
Blinding (performance bias and detection bias) All outcomes	High risk	Open‐label study
Incomplete outcome data (attrition bias) All outcomes	Low risk	36/493 (7.1%) on SiT and 35/493 (7.0%) discontinued treatment
Selective reporting (reporting bias)	Low risk	Data have been obtained for all primary outcome measures