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 |
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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 |
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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 |
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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 |
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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) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | Information not available (Cochrane Grade B) |