Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
26 participants
INTERVENTIONAL
2005-09-30
2006-07-31
Brief Summary
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A double-blind, randomized, placebo controlled, parallel group study will be undertaken in 18 atopic children with mild persistent asthma who will be treated with oral montelukast (5 mg/day for 4 weeks) and 18 atopic children with mild persistent asthma who will receive matching placebo.
A follow-up visit will be performed 2 weeks after montelukast or placebo withdrawal.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
montelukast sodium
one tablet 5 mg once/day for 4 weeks
2
placebo
one tablet 5 mg once/day for 4 weeks
Interventions
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montelukast sodium
one tablet 5 mg once/day for 4 weeks
placebo
one tablet 5 mg once/day for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* exhaled nitric oxide (NO) \>20 PPB at visit 2
* symptoms more often than twice a day, FEV1 equal or higher than 80% of predicted value and reversibility equal or higher than 12% to salbutamol, or a positive provocation test with methacholine, or exercise
* no regular medication, inhaled short-acting beta-2 agonists for symptom relief
Exclusion Criteria
* Patient has FEV1 \< 80% predicted on visit 1
* Patient has 2 or more nighttime awakenings for asthma per week or pef variability 30% or more
* upper respiratory infection in the previous 3 weeks
* treatment with glucocorticoids or LTRAs in the previous 4 weeks
* treatment with inhaled glucocorticoids for more than 4 weeks in the previous year
6 Years
14 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Catholic University of the Sacred Heart
OTHER
Responsible Party
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Catholic University of the Sacred Heart
Principal Investigators
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Paolo Montuschi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Catholic University of the Sacred Heart
Locations
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Catholic University of the Sacred Heart
Rome, , Italy
Countries
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Other Identifiers
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A/1064/2004
Identifier Type: -
Identifier Source: org_study_id
NCT00496496
Identifier Type: -
Identifier Source: nct_alias