Effect of Montelukast in Asthma in Children

The Effect of Montelukast on Anti-inflammatory Treatment and Asthma Exacerbation Prevention in Children Sensitive to Dust Mites.

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.

Study Overview

• Status: Unknown
• Conditions: Bronchial Asthma
• Intervention / Treatment: Drug: Montelukast sodium.; Drug: Placebo tablet and budesonide

Detailed Description

The most potent anti-inflammatory drugs in asthma are glucocorticosteroids. Corticosteroids, however have side effects and do not fully suppress the production or release of all inflammatory mediators. Amongst those less affected are cysteinyl leucotrienes, which are known to play a key role in asthma. Antileucotrienes have a bronchodilator and bronchoprotective potential and have thus became part of current treatment recommendations in asthma.

Owing to the beneficial effects of antileucotrienes and the efforts to keep steroid doses low, our study address the extent to which inhaled corticosteroids might be substituted or supplemented by these drugs. We used symptoms, frequency of exacerbation, exercise induced bronchoconstriction test, and exhaled NO during a stepwise reduction of steroid doses to assess the association between these variables and their relation to the patients' clinical benefit; we used airway hyperresponsiveness to assess inflammatory process in airways.

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.

Methods used in the study:

• doctor's exam
• asthma symptoms questionaire
• exhaled NO
• spirometry
• exercise induced bronchoconstriction test
• airway hyperresponsiveness test

End points:

• steroid doses sufficient to control asthma symptoms
• medium steroid dose/day times 6 month
• number of asthma exacerbations in 9 month period
• maximum fall of FEV1 in exercise induced bronchoconstriction test
• asthma symptoms scale and lung function
• number of patients with positive airway hyperresponsiveness test

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 3

Contacts and Locations

Study Locations

• Poland
  • Lodz, Poland, 93-513
    • Recruiting
    • Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital
    • Contact: Iwona Stelmach, Prof.; Email: alergol@kopernik.lodz.pl
    • Principal Investigator: Agata Ożarek-Hanc, MD

Participation Criteria

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 with bronchial asthma

Exclusion Criteria:

• All other serious diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: montelukast group; Children with asthma treated with montelukast and budesonide.	Drug: Montelukast sodium.; Children with asthma treated with montelukast and budesonide.; Other Names: Montelukast and Budesonide
Placebo Comparator: Placebo group; Children with asthma treated with placebo tablet and budesonide.	Drug: Placebo tablet and budesonide; Children with asthma treated with placebo tablet and budesonide.; Other Names: Placebo tablet and Budesonide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Steroid dose,medium steroid dose/day,number of asthma exacerbations,maximum fall of FEV1 in exercise, asthma symptoms, lung function, number of patients with positive airway hyperresponsiveness	steroid doses sufficient to control asthma symptoms; medium steroid dose/day times 6 month; number of asthma exacerbations in 9 month period; maximum fall of FEV1 in exercise induced bronchoconstriction test; asthma symptoms scale and lung function; number of patients with positive airway hyperresponsiveness test	9 months

Collaborators and Investigators

• Sponsor: Medical University of Lodz
• Investigators: Principal Investigator: Agata Ożarek-Hanc, MD, Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland.; Study Chair: Iwona Stelmach, Prof., Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland

Publications and helpful links

General Publications

• Stelmach I, Ozarek-Hanc A, Zaczeniuk M, Stelmach W, Smejda K, Majak P, Jerzynska J, Anna J. Do children with stable asthma benefit from addition of montelukast to inhaled corticosteroids: randomized, placebo controlled trial. Pulm Pharmacol Ther. 2015 Apr;31:42-8. doi: 10.1016/j.pupt.2015.01.004. Epub 2015 Jan 30.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: December 23, 2010
• First Submitted That Met QC Criteria: December 23, 2010
• First Posted (Estimate): December 24, 2010

Study Record Updates

• Last Update Posted (Estimate): February 7, 2013
• Last Update Submitted That Met QC Criteria: February 6, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: asthma; children; montelukast; treatment; exacerbation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Budesonide; Montelukast
• Other Study ID Numbers: RNN/213/10/KE (Other Identifier: Medical University of Lodz)