Exercise Induced Bronchoconstriction (0476-359)
Asthma, Exercise-induced
About this trial
This is an interventional diagnostic trial for Asthma, Exercise-induced
Eligibility Criteria
Inclusion Criteria:
- Patient is a man or woman who is between the ages of 18 and 55 years of age at Visit 1
- Female patients of that are of childbearing potential must show they are not pregnant either by blood test Visit 1 and agree to use appropriate single barrier or hormonal contraception during the course of the study and continuing for at least 14 days following the patient's last study visit
- The patient has stable asthma without any worsening (e.g., requiring unscheduled visit to a physician, hospital or other healthcare resource, new medications or change in dose or frequency of current medications) within 4 weeks of Visit 1 and Visit 2
- Patient is a current non-smoker and if has a history of smoking, has not smoked for at least 6 months and has a smoking history of no more than 15 pack-years (i.e., 1 pack per day for 15 years)
Exclusion Criteria:
- Patient has donated a unit of blood within 4 weeks prior to Visit 1 or anticipates donating blood at any time during this study
- Patient has participated in a clinical trial involving an investigational or marketed medication within the 4 weeks prior to Visit 1 or anticipates participating in any other clinical trial during this study. Patient is currently a regular user, or a recent past abuser (within the past 5 years), of alcohol or illicit drugs
- Patient is a female who has given birth in the last 8 weeks of Visit 1 or breast feeding an infant
- Patient is pregnant, or intends to become pregnant during the time course of the study. Patient is hospitalized or has had a major surgical procedure, major trauma requiring medical attention, or significant illness requiring medical attention within 4 weeks of Visit 1
- Patient does not agree to limit caffeinated beverages and/or chocolate within 8 hours of study visits. Patient has had a worsening of their asthma within 4 weeks of Visit 1 or Visit 2 (i.e., requiring change in type, dose or frequency of medications and/or an unscheduled visit to a health care provider, including emergency room or hospital). Patient has unresolved signs and/or symptoms of an upper respiratory tract infection within 4 weeks of Visit 1 or Visit 2
- Patient is unwilling to restrict vigorous exercise (e.g., weight lifting or long distance running) or abstain from performing strenuous activity within 18 hours of any visit
- Patient has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to: pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures) and/or ear implants
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Placebo Comparator
Placebo Comparator
I
II
III
Three period crossover study, 7 week duration: During periods I-III patients will receive oral medication as a single dose before exercise challenge. For the three periods of this study patients will receive in a randomized sequence one dose of montelukast 10mg and a matching placebo during the other 2 periods.
Three period crossover study, 7 week duration: During periods I-III patients will receive oral medication as a single dose before exercise challenge. For the three periods of this study patients will receive in a randomized sequence one dose of montelukast 10mg and a matching placebo during the other 2 periods.
Three period crossover study, 7 week duration: During periods I-III patients will receive oral medication as a single dose before exercise challenge. For the three periods of this study patients will receive in a randomized sequence one dose of montelukast 10mg and a matching placebo during the other 2 periods.