Status:
COMPLETED
Effects of Montelukast in Children With Asthma
Lead Sponsor:
Catholic University of the Sacred Heart
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Asthma
Eligibility:
All Genders
6-14 years
Phase:
PHASE3
Brief Summary
Leukotriene receptor antagonists (LTRAs) reduce fractional exhaled nitric oxide (FENO) concentrations in children with asthma, but the effect of LTRA withdrawal on FENO and lung function is unknown. W...
Eligibility Criteria
Inclusion
- Children 6 to 14 yrs old, step 1 and step 2 GINA (Global INitiative for Asthma) guidelines
- 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
- Patient is hospitalized
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00675285
Start Date
September 1 2005
End Date
July 1 2006
Last Update
May 9 2008
Active Locations (1)
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1
Catholic University of the Sacred Heart
Rome, Italy, 00168