Tamaoki 1997.

Methods	DESIGN ‐parallel‐group ‐multicentre ALLOCATION ‐Random ‐blocks of four at each center BLINDING ‐double‐blind ‐placebo‐controlled ‐identical placebo WITHDRAWAL/DROPOUTS ‐described JADAD's Quality Score = 4 Confirmation of methodology not obtained
Participants	WELL CONTROLLED PARTICIPANTS‐ SUDDEN ICS DOSE REDUCTION ‐RANDOMISED N = 79 Pranlukast = 43 Control = 40 WITHDRAWALS: Pranlukast = 2% Control = 8% GENDER: 43 % male AGE Pranlukast: 49 ± 3 years (SEM) Control: 47 ± 3 years SEVERITY: not described BASELINE FEV1 (% Pred) Pranlukast: 79.1 ±2.6 (SEM) Control: 81.6 ± 2.3 (SEM) ALLERGEN TRIGGERS: not described ASTHMA DURATION: Pranlukast: 11.3 ± 4.5 years (SEM) years Control: 10.6 ± 3.9 years ELIGIBILITY CRITERIA ‐Age >= 21 years old ‐Am PEF > 70%, or FEV1 > 70% Pred ‐< 10 asthma symptom score during previous 2 weeks ‐no systemic steroid course during previous 8 weeks, or < 4 short courses during past year ‐symptoms well controlled on daily dose of inhaled beclomethasone >= 1500 mcg for at least 6 weeks
Interventions	PROTOCOL: AL + ICS vs SAME dose ICS DURATION: ‐Run‐in Period: 2 weeks ‐Dose Optimisation period: none (sudden decrease in ICS at study onset) ‐Intervention Period: 6 weeks TEST GROUP ‐Pranlukast 450 mg bid p.o. + Beclomethasone dipropionate 1/2 of usual dose (? 750 ug/day) CONTROL GROUP ‐Placebo + Beclomethasone dipropionate 1/2 of usual dose(? 750 ug/day) DEVICE ‐metered‐dose aerosol inhaler ‐CO‐TREATMENT: ‐Oral beta2‐agonist (Pranlukast: 93%/Control:97%) ‐Oral theophylline: (Pranlukast:93%/Control:91%) ‐Inhaled anticholinergics (Pranlukast:50%/control:51%)
Outcomes	ANALYSES (intention‐to‐ treat not specified) ‐used at 6 weeks ‐PULMONARY FUNCTION TESTS ‐**Change from baseline FEV1 ‐Change from baseline Am PEF ‐Change from baseline Pm PEF ‐Change from baseline mean diurnal variation of PEF SYMPTOM SCORES ‐Change from baseline daytime asthma symptoms (episodes/week) ‐Change from baseline nighttime asthma symptoms (episodes/week) FUNCTIONAL STATUS ‐Change from baseline daytime use of B2‐agonists (puffs/weeks) ‐Change from baseline nighttime use of B2‐agonists (puffs/week) ‐Change in night wakings (episodes/week) ‐Number of patients experiencing exacerbations requiring systemic steroids INFLAMMATORY MARKERS ‐Change from baseline serum ECP (ug/L) ‐Change from baseline exhaled NO (ppb) ADVERSE EFFECTS ‐not reported WITHDRAWALS ‐reported (** denotes primary outcomes)
Notes	‐Full Text (1997) ‐Funded by Japanese Ministry of Educ, Sci, & Culture and Glaxo/ONO? ‐Request for confirmation of methodology and data extraction (sent to Tamaoki 28 May 1999) ‐No reply as of Sept 2001 ‐User‐defined order: 75 (mean intervention ICS dose of 750 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)