Yildirim 2001.
Methods | DESIGN
‐parallel‐group ALLOCATION ‐Random ‐Methods of randomisation: not reported ‐means of assignment: not reported BLINDING ‐not reported WITHDRAWAL/DROPOUT ‐not described JADAD's Quality Score = 1 ‐Confirmation of methodology not obtained |
|
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 ‐not reported EXCLUSION CRITERIA ‐not reported |
|
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. + BUD 400 mcg/day CONTROL GROUP (2 X ICS) ‐BDP 800 mcg/day DEVICE ‐not described ‐CO‐TREATMENT: none allowed |
|
Outcomes | INTENTION‐TO‐TREAT ANALYSIS
‐not described
‐outcomes reported at 12 weeks 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 ‐serum eosinophil counts ADVERSE EFFECTS ‐not reported WITHDRAWALS ‐not reported (* denotes primary outcomes) |
|
Notes | ‐Abstract 2001 ‐Funding source: not reported ‐Confirmation of methodology and data extraction: not obtained. User‐defined order: 40 (mean intervention (400) 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) |