Koopmans 2006

Methods	A randomised, double‐blind, single‐centre, parallel‐group study over 12 months from September 2000 to December 2003, in the Netherlands. Run‐in 4 weeks Study conducted to compare long‐term effects on airway inflammation of seretide vs flixotide in adult patients with asthma
Participants	Population: 54 adults (19 to 59 years) with mild to moderate persistent allergic asthma  Baseline characteristics: mean age 32 years; FEV₁ 89% predicted Concomitant ICS used by 100% of participants (median dose 600 μg/d)   Inclusion criteria: between 18 and 50 years of age with reversible airways obstruction, informed consent, allergic to house dust mite, PC20 histamine < 8 mg/mL, FEV₁ > 70% predicted   Exclusion criteria: serious concurrent disease likely to interfere with the study, lower respiratory tract infection, use of antibiotics in the previous 4 weeks
Interventions	• Fluticasone propionate and salmeterol 250/50 μg twice daily • Fluticasone propionate 250 μg twice daily Delivery was Diskus device
Outcomes	Primary efficacy variables: percentage of eosinophils and eosinophil cationic protein (ECP) in induced sputum (baseline and after allergen challenge) at randomisation and 1, 3 6, 9, and 11 months later
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	50/54 (93%) completed the study
Selective reporting (reporting bias)	Low risk	Data available on GSK website