Lundback 2006

Methods	A randomised, double‐blind, parallel‐group study over 12 months from August 1997 to December 2002, in Sweden. Run‐in 2 months An interventional 3‐year study for asthma control ‐ In what way and in what kind of population is it possible to get asthmatic patients free from symptoms, keep patients at work, restore normal lung function, diminish hyperreactivity, and normalise quality of life?
Participants	Population: 282 adults (18 to 70 years) with mild to moderate persistent asthma  Baseline characteristics: mean age 40 years; FEV₁ 93% predicted Concomitant ICS used by 68% of participants  Inclusion criteria: clinically representative mild to moderate asthma, symptoms, or use of rescue medication at least twice a week; required to have airway hyperreactivity (AHR) demonstrated by methacholine challenge with a PC20 (the concentration required to provoke a 20% reduction in FEV₁) < 8 mg/mL. If AHR was not demonstrated via methacholine challenge, then one of the following: diurnal variability in PEF ≥ 20% on more than 3 days during the last 14 days of the run‐in; at least 30% difference between highest and lowest PEF readings during any 7 days in the run‐in period; increase ≥ 15% in FEV₁ or PEF after salbutamol inhalation (0.8 mg)  Exclusion criteria: taking daily doses of ICS > 1200 μg, had experienced ≥ 1 life‐threatening exacerbation requiring hospitalisation during previous 12 months, were hypersensitive to beta‐agonists or ICS, were pregnant or lactating, had a respiratory tract infection during the 4 weeks before run‐in
Interventions	• Fluticasone propionate and salmeterol 250/50 μg twice daily • Fluticasone propionate 250 μg twice daily • Salmeterol 50 μg twice daily Delivery was Diskus device (arm 3 was not used in this review)
Outcomes	Primary efficacy variable: requirement for an increased dose of study medication
Notes	Sponsored by GSK
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Unclear risk	Not reported
Blinding (performance bias and detection bias) All outcomes	Low risk	Double‐blind
Independent Assessment of causation (detection bias) Asthma‐related events	High risk	Causation of SAEs not independently assessed
Incomplete outcome data (attrition bias) All outcomes	Low risk	263/282 (93%) completed the study
Selective reporting (reporting bias)	Low risk	Data on GSK website