Asthma
Conditions
Keywords
airway inflammation, childhood asthma, fractional exhaled nitric oxide, leukotriene receptor antagonists, lung function
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. 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.
Interventions
DRUGmontelukast sodium
one tablet 5 mg once/day for 4 weeks
DRUGplacebo
one tablet 5 mg once/day for 4 weeks
Sponsors
Merck Sharp & Dohme LLC
Catholic University of the Sacred Heart
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| post-treatment fractional exhaled nitric oxide | — |
Secondary
| Measure | Time frame |
|---|---|
| post-treatment FEV1 | — |
| post-treatment FVC | — |
| post-treatment FEV1/FVC | — |
| post-treatment FEF25%-75% | — |
| fractional exhaled nitric oxide 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 | — |
| FEV1 2 weeks after montelukast withdrawal | — |
Countries
Italy
Outcome results
None listed