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

Green 2002a.

Methods DESIGN 
 ‐cross‐over trial 
 ‐4 weeks for each of the 4 periods 
 ‐1‐month wash‐out between periods
ALLOCATION 
 ‐Random 
 ‐Means of randomisation: not specified 
 ‐Mode of allocation: not specified
BLINDING 
 ‐double‐blind 
 ‐mode of blinding: not specified
WITHDRAWL/DROPOUTS 
 ‐not described
JADAD's Quality score = 2
Confirmation of methodology 
 ‐ not obtained
Participants SYMPTOMATIC PARTICIPANTS
RANDOMISED 
 N = 49 for each of 4 periods
WITHDRAWALS 
 not reported
AGE: 
 not reported
GENDER (% male) 
 not reported
SEVERITY: 
 ?mild‐moderate asthma
BASELINE % predicted FEV1 ± (SD) 
 not reported 
 BUD 800: 
 BUD 200 + Montelukast: 
 BUD 200 + Formoterol: 
 BUD 200 + Placebo:
ALLERGIC RHINITIS: 
 ‐not reported
ASTHMA DURATION: 
 ‐not reported
ELIGIBILITY CRITERIA 
 ‐not reported
EXCLUSION CRITERIA 
 ‐not reported
Interventions PROTOCOL: 
 AL + ICS vs HIGHER dose ICS
DURATION: 
 ‐Run‐in Period: not described 
 ‐Intervention Period: 4 weeks 
 ‐Wash‐out period: 4 weeks
TEST GROUP 1 
 BUD 100 mcg bid + Montelukast 10 mg die
TEST GROUP 2 (not used in this review) 
 BUD 100 mcg bid + formoterol
CONTROL GROUP 1 
 4 x ICS: BUD 400 mcg bid
CONTROL GROUP 2 (not used in this review) 
 BUD 100 mcg bid
DEVICE 
 ‐not specified
CO‐TREATMENT: 
 ‐not reported
Outcomes INTENTION‐TO‐TREAT ANALYSES
PULMONARY FUNCTION TESTS 
 ‐change in FEV1 (L) 
 ‐*change in AM PEF (L/min)
SYMPTOM SCORES (PP) 
 ‐change in symptom score (scale 0 to 6)
FUNCTIONAL STATUS (PP) 
 ‐change in mean daily use of B2‐agonist (puffs/day) 
 ‐change in quality of life score (range 1‐7) 
 ‐change in nocturnal awakenings
INFLAMATORY MARKERS 
 ‐change in peripheral blood eosinophil count
ADVERSE EFFECTS 
 ‐not reported
WITHDRAWALS 
 ‐not reported
* primary outcome
Notes ‐Abstract 2002
‐Funding: not specified
‐Confirmation of methodology and data extraction: not obtained.
User‐defined order: 20 
 (mean intervention BUD dose in 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)