PASSION.

Methods	Study design: 26‐week randomised, open‐label, active control, parallel group multicentre study conducted at 15 centres in Turkey between March 2006 and September 2008
Participants	430 adults aged 18 years or older Inclusion Criteria: Age 18 years or over Ability to read and write in Turkish Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition (9). 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 Exclusion Criteria: Previous treatment with Symbicort Single Inhaler; Use of any beta‐blocking agent, including eye‐drops and oral GCS as maintenance treatment. Known or suspected hypersensitivity to study therapy or excipients. A history of smoking less than 10 pack years. Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to or at Visit 1.
Interventions	A comparison of Symbicort single inhaler therapy 200/6 (Symbicort Turbuhaler delivered dose 160/4.5 µg, 1 inhalation b.i.d. plus as‐needed) and conventional best practice (according to guidelines)
Outcomes	The primary outcome variable was time to first severe asthma exacerbations (hospitalisation for at least one day or at least 3 days of oral steroids). A secondary objective was to collect safety data for treatment in the two treatment groups in adult patients with persistent asthma
Notes	Results posted this trial (NCT00628758) on clinicaltrials.gov in July 2012
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation list (confirmed by sponsors)
Allocation concealment (selection bias)	Low risk	"in order to not reveal the randomised treatment of the next patient and to ensure that patients received randomised treatment, coded envelopes were prepared which revealed randomised treatment when opened" (information from sponsors)
Blinding (performance bias and detection bias) All outcomes	High risk	Open‐label study
Incomplete outcome data (attrition bias) All outcomes	High risk	44/209 (21%) on SiT and 42/221 (19%) on conventional best practice discontinued from the trial
Selective reporting (reporting bias)	Low risk	Data have been obtained for all primary outcome measures