Nsouli 2000.
Methods | DESIGN
‐parallel‐group ALLOCATION ‐Random ‐Methods of randomisation: not reported ‐means of assignment: not reported BLINDING ‐no blinding (open label) WITHDRAWAL/DROPOUT ‐not described JADAD's Quality Score = 1 ‐Confirmation of methodology not obtained |
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Participants | SYMPTOMATIC PARTICIPANTS RANDOMISED ‐ N= 30 ‐M10 + ICS = NR ‐2 X ICS= NR WITHDRAWALS ‐M10 + ICS =NR ‐2 X ICS= NR GENDER (% male) ‐M10 + ICS = NR ‐2 X ICS =NR AGE (SD) years ‐M10 + ICS = NR ‐2 X ICS= NR SEVERITY ‐not specified BASELINE PREDICTED FEV1 % (SD) ‐M10 + ICS = NR ‐2 X ICS = NR ALLERGEN TRIGGERS ‐not described ASTHMA DURATION (SD) years ‐ M10 + ICS = NR ‐2 X ICS = NR ELIGIBILITY CRITERIA ‐symptomatic on low dose of ICS (FP 100‐300 mcg; BDP 200 ‐ 1200 mcg; BUD 200‐400 mcg; flunisolide: 500‐1000 mcg; TAA:400‐1000 mcg) EXCLUSION CRITERIA ‐not reported |
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Interventions | PROTOCOL:
AL + ICS vs DOUBLE dose ICS DURATION ‐Run‐in Period: not described ‐Intervention period: 12 weeks TEST GROUP ‐Montelulast 10 mg die p.o. + Beclomethasone 200‐500/day or equivalent CONTROL GROUP (2 X ICS) ‐Beclomethasone 400‐1200 ug/day or equivalent DEVICE ‐not described ‐CO‐TREATMENT: not described |
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Outcomes | INTENTION‐TO‐TREAT ANALYSIS
‐not described
‐outcomes reported at 12weeks PULMONARY FUNCTION TESTS ‐Change from baseline AM PEFR ‐Change from baseline in FEV1 SYMPTOM SCORES ‐Change from baseline daytime symptom scores ‐Change from baseline nighttime symptoms FUNCTIONAL STATUS ‐Change from baseline mean daily B2‐agonist use INFLAMMATORY MARKERS ‐not reported ADVERSE EFFECTS ‐not reported WITHDRAWALS ‐not reported (* denotes primary outcomes) |
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Notes | ‐Abstract 2000 ‐Funding source: not reported ‐Confirmation of methodology and data extraction: not obtained. User‐defined order: 35 (mean intervention (350) 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) |