Comparison of Combination Therapy: Montelukast and Inhaled Steroid on Exercise Induced Bronchoconstriction

NCT00462592 | Completed Phase 3

• 1 other identifier: monbud8035
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Asthma

Keywords

exercise-induced bronchoconstriction (EIB); airway inflammation

Outcome Measures

Primary Outcomes (1)

• The magnitude of protection and the number of subjects with ≥50% protection (considered to be clinically relevant) following treatment

  Before and after 2 weeks of treatment in each 4 arm

Secondary Outcomes (4)

• Change in sputum cell counts and fluid phase inflammatory mediators

  Before and after 2 weeks of treatment in each 4 arm

• Change in baseline exhaled nitric oxide (eNO) and response to exercise challenge

  Before and after 2 weeks of treatment in each 4 arm

• Change in EBC (exhaled breath condensate) inflammatory mediators from baseline

  Before and after 2 weeks of treatment in each 4 arm

• The change in exercise induced maximal percent fall in FEV1 (maxFEV1%) and area under the curve (AUC0-30) relative to pre-exercise FEV1 up to 30 minutes following exercise challenge

  Before and after 2 weeks of treatment in each 4 arm

Study Arms (4)

1

ACTIVE COMPARATOR

montelukast - montelukast 5 mg ( \< 15 years) or 10 mg (and matching placebo)will be taken 1 tab in the evening

Drug: montelukast; Other: placebo

2

ACTIVE COMPARATOR

budesonide - inhaled budesonide turbuhaler 200ug (\& matching placebo) taken 1 puff morning \& 1 puff evening.

Drug: budesonide; Other: placebo

3

PLACEBO COMPARATOR

placebo

Other: placebo

4

ACTIVE COMPARATOR

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; Drug: montelukast; Other: placebo

Interventions

budesonide DRUG

inhaled budesonide turbuhaler 200ug taken 1 puff morning \& 1 puff evening.

Also known as: budesonide (Pulmicort)

2; 4

montelukast DRUG

montelukast 5 mg ( \< 15 years) or 10 mg (and matching placebo)will be taken 1 tab in the evening

Also known as: montelukast (Singulair)

1; 4

placebo OTHER

placebo

1; 2; 3; 4

Eligibility Criteria

• Age: 8 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Males or females ages 8-35 years with stable mild-to-moderate asthma (ATS criteria) not on regular controller therapy
• Prebronchodilator FEV1 predicted ≥ 70%
• No other medical co-morbidity
• Demonstrate maxFEV1% ≥15% on exercise challenge at screening and 1 week post run-in.

You may not qualify if:

• Asthma exacerbations or respiratory infection within 4 weeks of screening
• Recent use of inhaled or systemic steroids
• Immunosuppressives
• Antihistamines, NSAIDs and investigational drugs within 30 days
• Unable to reliably perform spirometry and exercise challenge
• Current or ex-smokers ≥ 10 pack-years and less than 1 month abstinence
• Contra-indications to inhaled steroids or montelukast use.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Hamilton Health Sciences-McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide; montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Paul O'Byrne, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 19, 2007
• Study Start: March 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 21, 2009

Record last verified: 2009-10

Locations

CA (2)