Godard 2008.

Methods	Study design: randomised controlled trial Total duration of study: 24 weeks. 'Run‐in' period: 8 weeks. All participants received salmeterol/fluticasone propionate combination (SFC) at a dose of 50/250 μg twice daily. Number of study centres and locations: 124 centres (no locations specified) Study setting: not stated Date of study: not stated
Participants	Enrolled (N): 603 Randomised (n): 475 (SFC 50/250, n = 159; SFC 50/100, n = 157; FP 250, n = 159) Analysed (n): 464 (SFC 50/250, n = 154; SFC 50/100, n = 156; FP 250, n = 154) Withdrawals (n): 63 Median age (range), years: SFC 50/250, 46.5 (18‐81); SFC 50/100, 43.0 (18‐75); FP 250 42.0 (18‐77) Age range, years: 18‐81 Gender (% female): SFC 50/250, 48.1; SFC 50/100, 46.2; FP 250 51.3 Severity of condition: well controlled on step 2 or 3. Mean % predicted prebronchodilator FEV1 (SD) as follows: SFC 50/250, 87.8 (18.2); SFC 50/100, 91.2 (17.8); FP 250, 90.8 (17.2) Diagnostic criteria: Asthma control was assessed using the GOAL definitions of 'well controlled' and 'total control'. Baseline lung function (mean morning PEF (SD), L/min): SFC 50/250, 465.6 (113.2); SFC 50/100, 467.9 (111.2); FP 250, 463.7 (105.1) Smoking history, % smokers or ex‐smokers: SFC 50/250, 24.7; SFC 50/100, 21.3; FP 250, 16.2 Inclusion criteria: aged ≥18 years; documented history of asthma (≥ 6 months) well controlled with current treatment (ICS at a dose of CFC beclomethasone dipropionate or equivalent and a long‐acting beta2‐agonist at recommended dose) at a stable dose for ≥ 4 weeks before initial clinic visit (V1); respiratory tract infection, with acute exacerbation requiring emergency department treatment/hospitalisation or use of oral/parenteral steroids, within 4 weeks of V1; any change in asthma maintenance treatment within 4 weeks Exclusion criteria: smoking history ≥ 10 pack‐years; respiratory tract infection Details of criteria for stepping down treatment: All participants received SFC 50/250 μg twice daily and were randomised to remain on SFC 50/250 or move to 1 of the 2 step‐down treatment arms if their asthma was assessed as 'well controlled' over the last 2 weeks of the run‐in period; asthma control was assessed according to GOAL definitions (see Bateman 2004).
Interventions	Intervention 1: SFC 50/100 μg twice daily Intervention 2: FP 250 μg twice daily (not relevant to review) Comparison: SFC 50/250 μg twice daily Concomitant medications: Short‐acting bronchodilators (previously used as rescue medication) and antihistamines were permitted, provided they had been used for at least 4 weeks. Excluded medications: All previous asthma medications were discontinued at entry into the run‐in period, except short‐acting bronchodilators (previously used as rescue medication) and antihistamines, provided they had been used for at least 4 weeks.
Outcomes	Primary outcomes: mean morning PEF over the first 12 weeks of randomised treatment Secondary outcomes: mean morning PEF over the last 12 weeks of randomised treatment; daily symptoms; use of short‐acting bronchodilator as rescue medication; FEV1; asthma control based on GOAL definitions of total control and 'well‐controlled' (see Bateman 2004)
Notes	Funding for trial: not stated Notable conflicts of interest of trial authors: Three of the trial authors had received sponsorship and had attended advisory boards for various pharmaceutical companies, including AstraZeneca, GlaxoSmithKline and Boehringer‐Ingelheim; 3 authors are employees of GlaxoSmithKline.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information provided
Allocation concealment (selection bias)	Unclear risk	Insufficient information provided
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Study reported as double blind
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Study reported as double blind
Incomplete outcome data (attrition bias) All outcomes	Low risk	Data provided for all randomised individuals. We note that study authors reported lung function results only for the per‐protocol population, whereas they reported all other outcomes for the intent‐to‐treat population.
Selective reporting (reporting bias)	High risk	Study authors reported the primary outcome for the per‐protocol data set on the basis that this is a non‐inferiority study. Furthermore, the primary outcome considers lung function only over the first 12 weeks of treatment; a secondary outcome assessed lung function in the full analysis set but considered only the second 12 weeks of treatment. All in all, findings were quite confusing and inconsistent. This trial was not reported as registered, and we cannot source a protocol.
Other bias	High risk	The protocol suggests that only participants whose condition was well controlled within the last 2 weeks of the run‐in period would go on to randomisation; however, it appears that a relatively high proportion of participants whose asthma was not controlled were included in the full analysis set. Results of this study are not well reported, and as the study does not appear to have been prospectively registered, and a protocol was not cited, it is difficult to ascertain whether selective outcome reporting occurred. Study sponsorship is not reported, although several authors worked for GSK. Key exclusion criteria of poor control according to ACQ were not defined or reported. A large proportion of poorly controlled randomised participants were not included in the primary outcome analysis (but were included in the secondary outcome analysis). Reporting was confusing.