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. 2004 Jan 26;2004(1):CD003133. doi: 10.1002/14651858.CD003133.pub2

Tomita 1999.

Methods DESIGN 
 ‐parallel‐group
ALLOCATION 
 ‐Random (method of randomisation not described) 
 ‐Mode of allocation (not described)
BLINDING 
 ‐none 
 ‐no placebo
WITHDRAWALS/DROP‐OUTS 
 ‐not reported
JADAD's Quality score = 1
Confirmation of methodology not obtained
Participants WELL‐CONTROLLED PARTICIPANTS‐ SUDDEN DECREASE OF ICS DOSE
RANDOMISED 
 N = 41 
 pranlukast = 24 control = 17
WITHDRAWALS 
 Pranlukast:? 
 Placebo:?
AGE 
 Pranlukast: 56.7 ± 18.0 years (SD) 
 Control: 42.2 ± 16.9 years
GENDER (% male): Pranlukast: 62% 
 Control: 59%
SEVERITY: 
 mild‐moderate asthma
BASELINE FEV1 (% predicted FEV1/HT): 
 Pranlukast: 90.3 ± 13.4 (SD) 
 Control: 86.3 ± 19.0
ALLERGEN TRIGGERS (% atopic): 
 Pranlukast: 67%/ Control: 65%
ASTHMA DURATION: not specified
ELIGIBILITY CRITERIA: 
 Adults with stable asthma well controlled on 800 mcg/day of beclomethasone for 3 months
EXCLUSION CRITERIA: 
 ‐non described
Interventions PROTOCOL: 
 AL + ICS vs SAME dose ICS
DURATION 
 ‐Run‐in Period (4 weeks) 
 ‐Dose Optimisation Period: NONE 
 ‐Intervention period ( 8 weeks)
TEST GROUP: 
 ‐Pranlukast 450 mg die p.o. 
 + ICS 400 mcg/day of beclomethasone
CONTROL GROUP: 
 ‐400 mcg/day of beclomethasone 
 ‐no placebo
DEVICE: 
 not described
‐CO‐TREATMENT: ? 2 patients on oral steroids (to be confirmed)
Outcomes NO INTENTION‐TO‐TREAT ANALYSES 
 ‐outcome used at 8 weeks
PULMONARY FUNCTION TESTS 
 (reported as cross‐sectional values not as change from baseline) 
 ‐FEV1 
 ‐V50 
 ‐V25 
 ‐morning % PEF 
 ‐evening % PEF 
 ‐diurnal PEF variation
SYMPTOM SCORES 
 (reported as cross‐sectional values not as change from baseline) 
 ‐symptom score 
 ‐therapeutic score 
 (both defined by the Japanese Society of Allergology)
FUNCTIONAL STATUS 
 ‐not reported (?)
INFLAMMATORY MARKERS 
 ‐not reported (?)
ADVERSE EFFECTS 
 ‐not reported (?)
WITHDRAWALS 
 ‐not reported (?)
(unclear primary outcome)
Notes ‐Full‐text (1999) Japanese paper with English abstract
‐Partial translation obtained from Cochrane Collaborator
‐Funding status (unknown)
‐Confirmation of methodology and data extraction (requested Jan 2001: pending)
‐User‐defined order: 40 
 (mean intervention ICS dose of 400 mcg/ day X 0.1)
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk Information not available (Cochrane Grade B)