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

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