SLGF75

Methods	A randomised, double‐blind, multi‐centre, parallel‐group study for 12 weeks from January 1998 to December 1998, at 7 centres in Italy. Run‐in 4 weeks, follow‐up 2 weeks Salmeterol plus low‐dose fluticasone propionate vs high‐dose fluticasone propionate in naive patients with mild to moderate asthma: effects on pulmonary function and inflammatory markers of induced sputum
Participants	Population: 46 adolescents and adults (16 to 65 years) with mild to moderate asthma Baseline characteristics: mean age 39 years; FEV₁ unreported % predicted Concomitant ICS used by 0% of participants   Inclusion criteria: performed on 3 study visits: • Pre‐study visit: all patients with asthma disease for ≥ 6 months  • Visit 2: 16 to 65 years old with asthma at moderate level (score of severity ≥ 6), did not use anti‐inflammatory drugs for last month before visit 1, FEV₁ % predicted ≥ 60%, eosinophils ≥ 5% in induced sputum  • Visit 4: bronchial asthma assessed up to 6 (severity classes value) and with persistence of eosinophils ≥ 5% (or ≥ 3% in sites where an amendment was applicable) in induced sputum Exclusion criteria: inhaled steroids or cromones in last 3 months, more than 1 short course of OCS in last 3 months or 1 short course of OCS in last month before pre‐study visit; respiratory tract infection in the last 1 month pre‐study visit, with lung or other important disease, or on beta‐blocker therapy; hypersensitivity to beta₂‐agonist and suspected to abuse drug or alcohol
Interventions	• Fluticasone propionate 100 + salmeterol 50 μg twice daily • Fluticasone propionate 100 μg twice daily • Fluticasone propionate 250 μg twice daily Delivery was Diskus (third arm not used in this review)
Outcomes	Primary efficacy endpoint: daily morning PEF
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	42/46 (91%) completed the study
Selective reporting (reporting bias)	Low risk	Data on GSK website