Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
160 participants
INTERVENTIONAL
2011-01-31
2013-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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montelukast group
Children with asthma treated with montelukast and budesonide.
Montelukast sodium.
Children with asthma treated with montelukast and budesonide.
Placebo group
Children with asthma treated with placebo tablet and budesonide.
Placebo tablet and budesonide
Children with asthma treated with placebo tablet and budesonide.
Interventions
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Montelukast sodium.
Children with asthma treated with montelukast and budesonide.
Placebo tablet and budesonide
Children with asthma treated with placebo tablet and budesonide.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Years
14 Years
ALL
No
Sponsors
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Medical University of Lodz
OTHER
Responsible Party
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Iwona Stelmach
MD, PhD, Prof
Principal Investigators
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Agata Ożarek-Hanc, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland.
Iwona Stelmach, Prof.
Role: STUDY_CHAIR
Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland
Locations
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Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital
Lodz, , Poland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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RNN/213/10/KE
Identifier Type: OTHER
Identifier Source: secondary_id
RNN/213/10/KE
Identifier Type: -
Identifier Source: org_study_id
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