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Effects of Montelukast in Children With Asthma

NCT00675285 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2008-05-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

montelukast sodium

one tablet 5 mg once/day for 4 weeks

DRUG

placebo

one tablet 5 mg once/day for 4 weeks

Sponsors & Collaborators

Principal Investigators

  • Paolo Montuschi, M.D. · Catholic University of the Sacred Heart

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2006-07-31
Completion
2006-07-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00675285 on ClinicalTrials.gov