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Sponsors and Collaborators: |
Hamilton Health Sciences Merck |
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Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00462592 |
The purpose of this study is to compare the effects of 2 weeks therapy of montelukast, budesonide, their combination on exercise induced bronchoconstriction (EIB) and airway inflammation in children and young adults, not on regular controller therapy.
Inhaled corticosteroids (ICS) are potent anti-inflammatory agents, which are effective in controlling and improving all aspects of asthma including the attenuation of EIB. However, the effect of ICS monotherapy on EIB is comparable if not inferior to the effect of CysLTs modifiers alone. This may be due to the lack of effect of ICS on the CysLT pathway. As a consequence, we hypothesize that the combination of ICS and CysLT modifiers will offer a greater protection against EIB than either therapy alone.The different classes of drugs may act on complementary pathways believed to be important in the pathophysiology of EIB.
Condition | Intervention | Phase |
---|---|---|
Asthma |
Drug: budesonide Drug: montelukast Drug: montelukast & budesonide Other: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | A Randomised Double Blind, Placebo Controlled 4-Way Cross Over Study Comparing Montelukast, Inhaled Budesonide and Their Combination on Exercise-Induced Bronchoconstriction |
Estimated Enrollment: | 20 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
montelukast
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Drug: montelukast
montelukast 5 mg ( < 15 years) or 10 mg (& matching placebo)will be taken 1 tab in the evening together with inhaled budesonide turbuhaler 200ug (& matching placebo) taken 1 puff morning & 1 puff evening.
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2: Active Comparator
budesonide
|
Drug: budesonide
montelukast 5 mg ( < 15 years) or 10 mg (& matching placebo)will be taken 1 tab in the evening together with inhaled budesonide turbuhaler 200ug (& matching placebo) taken 1 puff morning & 1 puff evening.
|
3: Placebo Comparator
placebo
|
Other: placebo
placebo
|
4: Active Comparator
montelukast budesonide combination
|
Drug: montelukast & budesonide
montelukast 5mg ( < 15 years) or 10 mg (& matching placebo)will be taken 1 tab in the evening together with inhaled budesonide turbuhaler 200 ug (& matching placebo) taken 1 puff morning & 1 puff evening.
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The study will be a 2 centre randomised, double blind, placebo controlled 4-way cross over study comparing montelukast, budesonide and their combination on exercise-induced bronchoconstriction (EIB). Subjects with stable mild to moderate asthma, between the ages of 8-35 years, not on controller asthma therapy will be screened. A maxFEV1% ≥15% following a standardized dry air exercise challenge at screening (SC) and following a 1 week run-in (V-1) is required to qualify. Once qualified, subjects will return the following day (V0) for a skin prick test and a methacholine inhalation test before being randomised to 1 of 4 treatment sequences. Each treatment will be given for a total of 14 days with a 4 weeks washout. During each period, subjects will attend the laboratory on 2 occasions, at the beginning and end of each period. Baseline spirometry; eNO; EBC will be performed, followed by an exercise challenge with serial FEV1 and eNO measurements up to 30 minutes post exercise and post-exercise EBC and sputum induction at each evaluation visit. There will be a total of 10 visits and the duration of study will be approximately 148 days (21 weeks). All visits will be scheduled within 2 hours of the post-run visit (V1) and at least 8 hours after the last dose of trial medications.
Investigational Product, Dose and Administration:
Montelukast 5mg (<15 years) or 10mg (and matching placebo) will be taken 1 tablet in the evening together with inhaled budesonide turbuhalers 200ug (and matching placebo) taken 1 puff in the morning and 1 puff in the evening.
Efficacy on EIB:
The changes between pre and post treatment exercise-induced maxFEV1% and area under the curve (AUC0-30) will be compared between the 4 periods. MaxFEV1% will be calculated as pre-exercise FEV1 minus post exercise lowest FEV1 divided by pre-exercise FEV1 multiplied by 100; AUC will be calculated using the trapezoidal rule. The protection provided by the active treatments will be defined as the pre-treatment maxFEV1% minus post-treatment maxFEV1% divided by pre-treatment maxFEV1% x 100. The proportions of subjects attaining ≥50% protection will be compared between the 4 arms.
Efficacy on eNO and inflammatory parameters measured in sputum and EBC Changes in % and absolute counts of sputum differential cells, eNO and inflammatory mediators (in EBC/ sputum) at baseline and in response to exercise will be compared between the 4 arms.
Ages Eligible for Study: | 8 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mylinh Duong, MD | 905-525-9140 ext 22561 | duongmy@univmail.cis.mcmaster.ca |
Contact: Padmaja Subbarao, MD | 416-813-6167 | padmaja.subbarao@sickkids.ca |
Canada, Ontario | |
Hamilton Health Sciences-McMaster University | Recruiting |
Hamilton, Ontario, Canada, L8N 3Z5 | |
Sub-Investigator: Mylinh Duong, MD | |
Hospital for Sick Children | Recruiting |
Toronto, Ontario, Canada, M5G 1X8 | |
Sub-Investigator: Padmaja Subbarao, MD |
Principal Investigator: | Paul O'Byrne, MD | McMaster University |
Responsible Party: | McMaster University ( Paul O'Byrne ) |
Study ID Numbers: | monbud8035 |
Study First Received: | April 18, 2007 |
Last Updated: | July 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00462592 |
Health Authority: | Canada: Health Canada |
exercise-induced bronchoconstriction (EIB) airway inflammation |
Montelukast Naphazoline Oxymetazoline Guaifenesin Phenylephrine |
Budesonide Asthma Phenylpropanolamine Leukotriene Antagonists Inflammation |
Anti-Inflammatory Agents Respiratory System Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Asthmatic Agents Glucocorticoids |
Hormones Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |