DE‐SOLO.

Methods	A comparison of Symbicort single inhaler therapy (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 adults ‐ a 26‐week, randomised, open‐label, parallel‐group, multicentre study. Dec 2004 to October 2006. 169 centres in Germany. No report of run‐in. The purpose of this study is to determine whether Symbicort dosed according to the Symbicort Maintenance and Reliever Therapy (SMART) concept is superior to standard asthma treatment according to the local German treatment guidelines.
Participants	1477 adults aged 18 years or older Inclusion Criteria: Patients with asthma, either well‐controlled on a regular therapy with a combination of long‐acting beta2‐agonists (LABA) and inhaled corticosteroids (ICS) or symptomatic on therapy with ICS alone. Exclusion Criteria: Any other significant lung disease other than asthma Any disease that might put patients at risk if they participate in the study
Interventions	Symbicort Turbuhaler 160/4.5 µg, 1 inhalation b.i.d. plus as‐needed Conventional best practice
Outcomes	Primary Outcome Measures: Time to first severe asthma exacerbation Secondary Outcome Measures: Number of severe asthma exacerbations Mean use of as‐needed medication Change in forced expiratory volume in 1 second (FEV1) from the end of run‐in to the end of the study period Prescribed asthma medication during the treatment period Asthma Control Questionnaire (ACQ) Patient's satisfaction with the treatment question Healthcare contacts Asthma medication Time lost from paid and unpaid work Serious adverse events (SAEs) Discontinuations due to adverse events (AEs) Definition of severe exacerbation Treatment with oral corticosteroids (including one patient with IV corticosteroids), hospitalisation or ER treatment
Notes	Results obtained from a report on AstraZeneca web site. No results posted for NCT00252863 on ClinicalTrials.gov in December 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	43/736 (5.8%) on SiT and 54/724 (7.5%) on current best practice discontinued treatment
Selective reporting (reporting bias)	Low risk	Data have been obtained for all primary outcome measures (with the exception of hazard ratio of time to first exacerbation)