Effects of Montelukast in Children With Asthma
Information source: Catholic University of the Sacred Heart
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: montelukast sodium (Drug); placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Catholic University of the Sacred Heart Official(s) and/or principal investigator(s):
Paolo Montuschi, M.D., Principal Investigator, Affiliation: Catholic University of the Sacred Heart, Rome, Italy
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. We will aim to study the effect of treatment and withdrawal of
montelukast, a LTRA, on airway inflammation as reflected by FENO and lung function in
children with asthma.
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.
Clinical Details
Official title: Effects of Oral Montelukast on Airway Inflammation in Children With Mild Asthma
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: post-treatment fractional exhaled nitric oxide
Secondary outcome: fractional exhaled nitric oxide 2 weeks after montelukast withdrawalpost-treatment FEV1 post-treatment FVC post-treatment FEV1/FVC post-treatment FEF25%-75% FEV1 2 weeks after montelukast withdrawal FVC 2 weeks after montelukast withdrawal FEV1/FVC 2 weeks after montelukast withdrawal FEF25%-75% 2 weeks after montelukast withdrawal asthma exacerbation rate
Eligibility
Minimum age: 6 Years.
Maximum age: 14 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Catholic University of the Sacred Heart, Rome 00168, Italy
Additional Information
Starting date: September 2005
Ending date: July 2006
Last updated: May 8, 2008
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