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

Wada 1999.

Methods DESIGN: 
 ‐parallel group
ALLOCATION 
 ‐Random 
 ‐Method of randomisation not described 
 ‐Mode of treatment allocation not described
BLINDING 
 ‐none
WITHDRAWALS/DROPOUTS 
 ‐Described
JADAD's Quality Score=1
CONFIRMATION OF METHODOLOGY: ‐not obtained
Participants SYMPTOMATIC PARTICIPANTS
RANDOMISED 
 N = 80 
 Pranlukast = 40 Control = 40
WITHDRAWAL 
 Pranlukast: 8% 
 Control: 18%
AGE: 
 pranlukast 50.8 years ±2.4 (SEM) 
 Control: 48.4 years ± 2.2 (SEM)
GENDER (% male): 
 Pranlukast: 59% 
 Control: 40%
SEVERITY: moderate asthma
BASELINE FEV1 (L): 
 Pranlukast: 1.83 L 
 Control: not reported
ALLERGEN TRIGGERS: 
 Pranlukast: 54% 
 Control: 51%
BASELINE BDP DOSE: Pranlukast: 1048.6 ± 39.1 mcg/day 
 Control: 1127.3 ± 53.5 mcg/day
ELIGIBILITY CRITERIA 
 Adults not well controlled on: 
 ‐ 800 mcg/day of beclomethasone ± slow‐release theophylline for 3 months 
 ‐FEV1 > 50% of predicted 
 ‐Reversibility in FEV1 > 15% post B2‐agonists 
 on 800 mcg/day of beclomethasone for 3 months
EXCLUSION CRITERIA: 
 ‐no systemic steroids and no upper respiratory tract infection in past 4 weeks
Interventions PROTOCOL: 
 AL + ICS vs SAME dose ICS
DURATION: 
 ‐Run‐in period: 2 weeks to establish baseline 
 ‐Dose optimisation period: NONE 
 ‐Intervention period: 4 weeks
TEST GROUP: 
 ‐Pranlukast 225 mg bid po + 800‐1200 mcg/day of beclomethasone
CONTROL GROUP: 
 ‐800‐1200 mcg/day of beclomethasone 
 ‐no placebo
DEVICE: 
 ‐not described
CO‐TREATMENT: 
 unspecified % on slow‐release theophylline
Outcomes ANALYSIS (intention‐to‐treat not specified) 
 ‐outcomes used at 4 weeks
PULMONARY FUNCTION TESTS
‐FEV1 (L) 
 ‐morning PEF (L/min) 
 ‐V25/HT (L/min)
SYMPTOMS SCORES 
 (reported as cross‐sectional values, not change from baseline) 
 ‐symptom scores averaged over 2 weeks 
 (scale 0‐9)
FUNCTIONAL STATUS 
 (reported as cross‐sectional values, not change from baseline) 
 ‐use of rescue Beta2‐agonist (puffs/week) 
 ‐exacerbations requiring systemic steroids
INFLAMMATORY MARKERS 
 (reported as cross‐sectional values, not change from baseline) 
 ‐sputum eosinophils(%) 
 ‐serum eosinophils (/uL) 
 ‐serum ECP(ng/uL) 
 ‐serum total IgE 
 ‐serum Der f‐specific IgE
ADVERSE EFFECTS 
 ‐not reported
WITHDRAWALS 
 ‐reported
Primary outcome 
 not specified
Notes ‐Full‐text (2000) paper
‐funding status (not reported)
‐confirmation of methodology and data extraction (pending)
‐User‐defined order: 100 
 (mean intervention ICS dose of 1000 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)