Kanniess 2002.

Methods	DESIGN ‐cross‐over trial ‐6 weeks for each period ‐no wash‐out between periods ‐dose reduction of 50% at beginning of each period ALLOCATION ‐Random: Computer‐generated random number ‐means of assignment: opaque consecutive numbered envelopes BLINDING ‐double‐blind ‐placebo‐controlled ‐identical placebo WITHDRAWL/DROPOUTS ‐described JADAD's Quality score = 5 Confirmation of methodology ‐ obtained
Participants	WELL‐CONTROLLED PARTICIPANTS RANDOMISED N = 50 ‐Montelukast = 26 ‐Control = 24 WITHDRAWALS: ‐Montelukast = 3 (11.54%) ‐Control = 2 (8.33%) AGE: ‐Montelukast: 38 ± 12 (SEM) years ‐Control: 43± 11 (SEM) years GENDER (% male): ‐Montelukast: 50% ‐Control: 46% SEVERITY: ‐moderate bronchial asthma BASELINE % PREDICTED FEV1: ‐Montelukast: 95.0 ± 2 (SEM) ‐Control: 92.3 ± 1.8 (SEM) ATOPY: not reported ASTHMA DURATION: not reported ELIGIBILITY CRITERIA ‐taking a dose of ICS (Beclomethasone or equivalent) 800 ug/day for more than 8 weeks prior to randomisation ‐FEV1 > 80% predicted ‐no oral corticosteroids within 6 months of entry to study ‐no oral antihistamines within 4 weeks of entry to study ‐provocation concentration of methacholine causing a 20% fall in FEV1 (PC20) <8mg/mL ‐FEV1 and PC20 be reproducible within 15% and 1.5 doubling concentrations, respectively, between visits one and two ‐ no smokers ‐no signs of an acute exacerbation or respiratory tract infection within 4 weeks prior to screening EXCLUSION CRITERIA ‐none mentioned
Interventions	PROTOCOL ‐AL + ICS vs same dose ICS (TAPERING ICS) DURATION ‐Run‐in Period: 1‐3 weeks ‐Dose optimisation period: none ‐Intervention Period: 6 weeks (X 2 periods) TEST GROUP Period 1 ‐Montelukast 10 mg once daily + ‐BDP 800 mcg/day or equivalent Period 2: Placebo + BDP‐eq 400 mcg/day CONTROL GROUP Period 1 ‐Placebo + BDP 800 mcg/day or equivalent Period 2 ‐Montelukast 10 mg die + BDP‐eq 400 mcg/day DEVICE ‐not reported CO‐TREATMENT: ‐none reported (need confirmation) CRITERIA FOR TAPERING ‐1st treatment period ICS reduced to 50% baseline (400 ug/day) ‐2nd treatment period ICS reduced to 50% of 1st treatment (25% of baseline or 200ug/day) * For purpose of the analysis, because this unusual design did not allow merging of the two periods and because no significant change in asthma control occurred in the first period suggesting of over‐treatment at baseline, the second period was arbitrarily chosen for analysis.
Outcomes	INTENTION‐TO‐TREAT ANALYSES ‐ yes PULMONARY FUNCTION TESTS ‐data are given as changes relative to baseline (1st period) and relative to each other (2nd period) ‐ change in FEV1 (L) ‐ change in PEF daytime ‐ change in PEF night‐time ‐ change in PC20 SYMPTOM SCORES ‐ change in daytime symptoms score (range 0 ‐ 4) ‐ change in night‐time symptoms score (range 0 ‐ 4) FUNCTIONAL STATUS ‐Use of rescue B2‐agonists (puffs/day) ICS DOSE REDUCTION: ‐ fixed by protocol INFLAMMATORY MARKERS: ‐data are given as changes relative to baseline (1st period) and relative to each other (2nd period) ‐exhaled NO ppb ‐% sputum eosinophils ADVERSE EFFECTS ‐reported (personal communication) WITHDRAWALS ‐reported
Notes	‐Full‐text (2002) publication and unpublished data ‐Funds by an educational grant from MSD, Munich, Germany ‐Confirmation of data extraction and methodology graciously obtained from Dr Frank Kanniess, from the Pulmonary Research Institute, Germany, August 2003. ‐User defined number = 40 (mcg of beclomethasone‐equivalent at baseline of the 2nd period) (mean ICS dose of 400 mcg/ day X 0.1)
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment (selection bias)	Low risk	Study investigators unaware as to order of treatment group assignment (Cochrane Grade A)