Effects of Montelukast in Children With Asthma

May 8, 2008 updated by: Catholic University of the Sacred Heart

Effects of Oral Montelukast on Airway Inflammation in Children With Mild Asthma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Catholic University of the Sacred Heart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 14 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Drug: placebo
one tablet 5 mg once/day for 4 weeks
ACTIVE_COMPARATOR: 1
Drug: montelukast sodium
one tablet 5 mg once/day for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
post-treatment fractional exhaled nitric oxide

Secondary Outcome Measures

Outcome Measure
fractional exhaled nitric oxide 2 weeks after montelukast withdrawal
post-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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Collaborators

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (ACTUAL)

July 1, 2006

Study Completion (ACTUAL)

July 1, 2006

Study Registration Dates

First Submitted

May 7, 2008

First Submitted That Met QC Criteria

May 8, 2008

First Posted (ESTIMATE)

May 9, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 9, 2008

Last Update Submitted That Met QC Criteria

May 8, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A/1064/2004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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