Effects of Montelukast in Children With Asthma

Catholic University of the Sacred Heart

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: placebo

Drug: montelukast sodium

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00675285

A/1064/2004

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

6 to 14 years old

Volunteers

No Healthy Volunteers

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