Status:
COMPLETED
Exercise Induced Bronchoconstriction (0476-359)
Lead Sponsor:
Organon and Co
Conditions:
Asthma, Exercise-induced
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Exercise-induced bronchoconstriction (EIB) is a condition where airways tighten when you exercise and may cause coughing, wheezing, or shortness of breath. In many patients, this condition can cause l...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00664937
Start Date
May 1 2007
End Date
October 1 2008
Last Update
May 9 2024
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