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

Riccioni 2001.

Methods DESIGN 
 ‐parallel group
ALLOCATION 
 ‐Random 
 ‐method of randomization: computer generated 
 ‐method of assessment: not mentioned
BLINDING 
 ‐reported as double‐blind (patient and assessor) but without placebo
WITHDRAWAL/DROPOUT 
 ‐described
JADAD's Quality Score = 2
‐Confirmation of methodology: received (Oct 2003)
Participants SYMPTOMATIC PARTICIPANTS
RANDOMISED: 
 N = 48 
 Z= 12 
 BUD= 12 
 Z+BUD= 12 
 Control= 12
WITHDRAWALS; 
 Z=2 (16%) 
 BUD= 1 (8%) 
 Z+BUD= 2 (16%)
AGE: mean (± SD) years 
 Z: 
 33.75 (±11.24) 
 BUD: 
 32.15 (±10.27) 
 Z+BUD: 
 33.44 (±11.12) 
 Control: 
 29.15 (±10.34)
GENDER (% male): 
 Z: 6 (50) 
 BUD: 6 (50) 
 Z+BUD: 6 (50) 
 Control: 6 (50)
BASELINE SEVERITY: 
 ‐mild persistent
% Predicted FEV1 (Mean +‐ SD) 
 Z: 
 94.75 ± 7.68 
 BUD: 
 92.75 ± 9.87 
 Z+BUD: 
 92.16 ± 5.06 
 Control: 
 95.75 ± 5.84
ATOPY/ALLERGEN TRIGGERS: 
 ‐not reported
ASTHMA DURATION (years) 
 ‐1 year
ELIGIBILITY CRITERIA 
 ‐1 year of mild persistent bronchial asthma 
 ‐PEF >80% pred. and PEF daily variability in 20‐30% range with positive salbutamol reversibility test
EXCLUSION: 
 ‐URTI in last 3 weeks 
 ‐hospitalization for asthma in the last 3 months 
 ‐treatment with antihistamines, anticholinergics, theophylline drugs 
 ‐presence of autoimmune, hepatic, or renal disorders 
 ‐malabsorption, drug or alcohol addiction 
 ‐pregnancy or lactation
Interventions PROTOCOL
Duration 
 ‐run‐in Period: 2 weeks 
 ‐Intervention: 8 weeks
TEST GROUP: 
 ‐Zafirlukast 20 mg bid
TEST GROUP 2 
 ‐Zafirlukast 20 mg bid + Budesonide 
 400 g bid
CONTROL GROUP 
 ‐Budesonide 400 g bid
CONTROL GROUP 2 
 ‐Placebo
DEVICE: 
 ‐not reported
CO‐INTERVENTION: 
 ‐not reported
Outcomes ANALYSIS PER PROTOCOL 
 (not by ITT)
OUTCOMES 
 ‐reported at 8 weeks
PULMONARY FUNCTION TEST 
 ‐pre‐ and post FVC values 
 ‐pre‐ and post FEV1 
 ‐pre‐ and post PC20
SYMPTOM SCORES 
 ‐not reported
FUNCTIONAL STATUS 
 ‐not reported
INFLAMMATORY MEDIATORS 
 ‐not reported
ADVERSE EVENTS 
 ‐not mentioned
WITHDRAWALS 
 ‐not reported
Primary outcome not specified
Notes ‐Full‐text publication (2001)
Funded by University
‐confirmation of methodology and data extraction: obtained from Graziano Riccioni, Oct 2003
USER‐DEFINED ORDER: 800 (daily dose of BDP‐equivalent=800 mcg )
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) High risk Study investigators aware as to treatment group assignment (Cochrane Grade C)