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Effect of Montelukast in Asthma in Children

NCT01266772 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2013-02-07

No results posted yet for this study

Summary

This is 9 month, placebo-controlled, double blind, randomised trial using the oral leucotrienes receptor antagonist montelukast (5 mg) in 160 children with mild and moderate asthma age 6-14 year old, sensitive to house dust mite. There are two study groups: montelukast group 80 patients and placebo group 80 patients. All patients will receive budesonide in dose sufficient to control asthma symptoms and short-acting beta agonist as needed. Medication used in the study: montelukast 5mg, budesonide. There are 7 doctor's visits - one initial visit (June) and 6 follow-up visits. First visit is on the first day of asthma symptom and each follow-up visit is every 6 weeks. Children with full asthma control (as measured by exhaled NO) had administered 100 mcg lower dose of budesonide and children with not fully control asthma had administered 100 mcg higher dose of budesonide.

Conditions

  • Bronchial Asthma

Interventions

DRUG

Montelukast sodium.

Children with asthma treated with montelukast and budesonide.

DRUG

Placebo tablet and budesonide

Children with asthma treated with placebo tablet and budesonide.

Sponsors & Collaborators

  • Medical University of Lodz

    lead OTHER

Principal Investigators

  • Agata Ożarek-Hanc, MD · Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland.

  • Iwona Stelmach, Prof. · Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Poland

Study Locations

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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 NCT01266772 on ClinicalTrials.gov