Buhl 2006.

Methods	STUDY DESIGN: Parallel group LOCATION, NUMBER OF CENTRES: Europe and South Africa, 57 centres. DURATION OF STUDY: 12 weeks (1‐4 week run‐in with suspension of usual ICS) CONCEALMENT OF ALLOCATION: Unclear COCHRANE QUALITY SCORE: B DESCRIBED AS RANDOMISED: Yes DESCRIBED AS DOUBLE BLIND: Yes METHOD OF RANDOMISATION WELL DESCRIBED/APPROPRIATE: Not reported METHOD OF BLINDING WELL DESCRIBED/APPROPRIATE: yes appropriate (double dummy) DESCRIPTION OF WITHDRAWALS/DROPOUTS: Yes JADAD SCORE (5‐1): 4 TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): ITT COMPLIANCE: Not reported CONFOUNDERS: Baseline values comparable. Note: Patients in two treatment groups were balanced with regard to prior use of ICS and other treatment medications (unclear how this was done).
Participants	N SCREENED: 644 N RANDOMISED: 529 N COMPLETED: 451 (PP) but with 529 (ITT analysis) M = 224; F = 305 MEDIAN AGE (range): CIC160 41 years (12‐74); FP88 38 (12‐74) BASELINE DETAILS: FEV1 (% Pred): CIC160 2.383 (75%); FP88 2.440 (75%) INCLUSION CRITERIA: Aged 12‐75 years; persistent asthma for 6 months ATS definition; previous use of ICS for 6 months (constant dose up to 500 ug/day BDP or equivalent for 4 weeks and an FEV1 of 80‐100% pred. At randomisation patients were required to have FEV1 50‐90% after rescue was withheld for 4 hours and a decrease in FEV1 >= 10% after ICS withdrawal and a reversibility of FEV1 >= 15% after 2‐4 puffs salbutamol or a diurnal variation in PEF of 15% during baseline period. EXCLUSION: Use of systemic steroids within 4 weeks of baseline or more than 3 times within last 6 months or had an asthma exacerbation, LRTI or asthma hospitalisation within 4 weeks. Had other lung disease such as COPD, or significant smoking history >= 10 pack years. "
Interventions	1. Ciclesonide 200 mcg OD in evening (double dummy placebo) 2. Fluticasone 100 mcg BID DELIVERY: CIC: MDI, FP: HFA MDI TREATMENT PERIOD: 12 weeks RESCUE: Salbutamol MDI CO‐INTERVENTIONS PERMITTED: None % on ICS baseline: 0
Outcomes	FEV1; am PEF; rescue medication use; adverse events; withdrawals
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear