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Effect of Montelukast in Asthma in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Medical Universtity of Lodz
Sponsor:
Information provided by (Responsible Party):
Iwona Stelmach, Medical Universtity of Lodz
ClinicalTrials.gov Identifier:
NCT01266772
First received: December 23, 2010
Last updated: February 6, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Bronchial Asthma
Drug: Montelukast sodium.
Drug: Placebo tablet and budesonide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Montelukast on Anti-inflammatory Treatment and Asthma Exacerbation Prevention in Children Sensitive to Dust Mites.

Resource links provided by NLM:


Further study details as provided by Medical Universtity of Lodz:

Primary Outcome Measures:
  • 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 [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    • 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


Estimated Enrollment: 160
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: montelukast group
Children with asthma treated with montelukast and budesonide.
Drug: Montelukast sodium.
Children with asthma treated with montelukast and budesonide.
Other Name: 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 Name: 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
  Eligibility

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children with bronchial asthma

Exclusion Criteria:

  • All other serious diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01266772

Contacts
Contact: Agata Ożarek-Hanc, MD 0048426895972 alergol@kopernik.lodz.pl

Locations
Poland
Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital Recruiting
Lodz, Poland, 93-513
Contact: Iwona Stelmach, Prof.       alergol@kopernik.lodz.pl   
Principal Investigator: Agata Ożarek-Hanc, MD         
Sponsors and Collaborators
Medical Universtity 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
  More Information

No publications provided

Responsible Party: Iwona Stelmach, MD, PhD, Prof, Medical Universtity of Lodz
ClinicalTrials.gov Identifier: NCT01266772     History of Changes
Other Study ID Numbers: RNN/213/10/KE, RNN/213/10/KE
Study First Received: December 23, 2010
Last Updated: February 6, 2013
Health Authority: Poland: Ethics Committee

Keywords provided by Medical Universtity of Lodz:
asthma; children; montelukast; treatment; exacerbation

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Budesonide
Montelukast
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014