SYMPHONIE.

Methods	Study design: 26‐week randomised, open‐label, active control, parallel‐group study conducted in 82 centres in France between September 2004 and January 2006
Participants	Inclusion Criteria: Age 12 years or over Minimum of 3 months history of asthma Prescribed IGCS at a dose of at least 400 µg/day (320 µg/day released does) and within the approved label for the relevant drug during the last 3 months prior to Visit 1. Either daily maintenance treatment with both IGCS and LABA or daily treatment with IGCS alone (i.e. without LABA) A history of sub optimal asthma control the month prior to enrolment as judged by the investigator Use of at least 3 inhalations of as‐needed medication for symptom relief during the last 7 days before enrolment
Interventions	A comparison of Symbicort SiT 200/6 (Symbicort Turbuhaler delivered dose 160/4.5 µg, 1 inhalation b.i.d. plus as‐needed) and conventional best practice (according to GINA and ANAES guidelines)
Outcomes	The primary outcome variable was time to first severe asthma exacerbations. The definition of a severe asthma exacerbation was oral corticosteroids for at least three days, ER treatment or hospitalisation for asthma.
Notes	No results posted this trial (NCT00259792) on clinicaltrials.gov by December 12th 2012
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	53/517 (10.3%) on SiT and 40/491 (8.2%) on conventional best practice discontinued prematurely
Selective reporting (reporting bias)	Low risk	Data have been obtained for all primary outcome measures

ACQ: Asthma Control Questionnaire; AE: adverse events; BDP: budesonide plus formoterol; BHQ: Bronchial Hyperresponsiveness Questionnaire; b.i.d: twice daily; DAE: discontinuations due to AE; ED/ER: emergency department/room; FEV_1: forced expiratory volume in 1 second; GINA: Global Initiative for Asthma; ICS: inhaled corticosteroids; IGCS: inhaled glucocorticosteroids; ITT: intention‐to‐treat; IV: intravenous; LABA: long‐acting β2‐agonist; PEF: peak expiratory flow; PRO: patient‐reported outcomes; QOL: quality of life; SAE: serious adverse event; SATQ: Satisfaction with Asthma Treatment Questionnaire; SD: standard deviation; SiT: single inhaler therapy