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| Sponsor: | Hamilton Health Sciences Corporation |
|---|---|
| Collaborator: |
Merck |
| Information provided by: | McMaster University |
| ClinicalTrials.gov Identifier: | NCT00462592 |
Purpose
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, the investigators 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 Other: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomised Double Blind, Placebo Controlled 4-way Cross Over Study Comparing Montelukast, Inhaled Budesonide and Their Combination on Exercise-induced Bronchoconstriction |
| Enrollment: | 18 |
| Study Start Date: | March 2007 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
montelukast - montelukast 5 mg ( < 15 years) or 10 mg (and matching placebo)will be taken 1 tab in the evening
|
Drug: montelukast
montelukast 5 mg ( < 15 years) or 10 mg (and matching placebo)will be taken 1 tab in the evening
Other Name: montelukast (Singulair)
Other: placebo
placebo
Other Name: placebo
|
|
Active Comparator: 2
budesonide - inhaled budesonide turbuhaler 200ug (& matching placebo) taken 1 puff morning & 1 puff evening.
|
Drug: budesonide
inhaled budesonide turbuhaler 200ug taken 1 puff morning & 1 puff evening.
Other Name: budesonide (Pulmicort)
Other: placebo
placebo
Other Name: placebo
|
|
Placebo Comparator: 3
placebo
|
Other: placebo
placebo
Other Name: placebo
|
|
Active Comparator: 4
montelukast budesonide combination - 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.
|
Drug: budesonide
inhaled budesonide turbuhaler 200ug taken 1 puff morning & 1 puff evening.
Other Name: budesonide (Pulmicort)
Drug: montelukast
montelukast 5 mg ( < 15 years) or 10 mg (and matching placebo)will be taken 1 tab in the evening
Other Name: montelukast (Singulair)
Other: placebo
placebo
Other Name: placebo
|
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.
Eligibility| Ages Eligible for Study: | 8 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada, Ontario | |
| Hamilton Health Sciences-McMaster University | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Principal Investigator: | Paul O'Byrne, MD | McMaster University |
More Information
| Responsible Party: | Paul O'Byrne, McMaster University |
| ClinicalTrials.gov Identifier: | NCT00462592 History of Changes |
| Other Study ID Numbers: | monbud8035 |
| Study First Received: | April 18, 2007 |
| Last Updated: | October 20, 2009 |
| Health Authority: | Canada: Health Canada |
|
exercise-induced bronchoconstriction (EIB) airway inflammation |
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Budesonide Montelukast Bronchodilator Agents Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents Leukotriene Antagonists Hormone Antagonists |
