The reason for this research study is to evaluate whether the investigational medication is safe and effective in decreasing the symptoms of exercise-induced bronchospasm (EIB). Subjects from four countries will participate in this research study. It will enroll 64 boys and girls aged 4 to 14 years with symptoms of EIB.

This research study is designed so that all children who participate will receive the investigational medication during one phase of the study and a placebo during another phase of the study. A placebo is a look-alike tablet that contains no active ingredients. This is a double-blind research study which means that neither you nor the study doctor and staff will know when your child is taking the investigational medication versus the placebo.

There will be no charge for the investigational medication, study visits or tests that your child will receive while in the research study. There are certain potential risks with the investigational medication that the study doctor will explain to you.

The research study medication for this research study is approved to treat chronic asthma in children as young as 1 year old. The study investigational medicine is not approved for the use being investigated in this study. In prior studies of the investigational medicine, participants have reported side effects, which the study doctor can explain to you.

To see if your child is eligible for the research study, the study doctor will:

• Review medical history (including baseline asthma profile questionnaire)
• Review prior and current therapy (including
  asthma therapy)
• Perform a study-related exam, height, and weight
• Vital signs (blood pressure, heart rate)
• ECG (12-lead)
• Laboratory tests
• There will be 7 visits over a 2 to 5 week period.

If your child joins the research study, you will receive a copy of the "Visit-By-Visit" Guide so that both of you will know what to expect at each appointment.

It is important that your child keep appointments so that the study doctor can monitor your child’s progress during the research study. If you need to reschedule an appointment, please call the office so they can give you a more convenient time.

If your child is eligible to join the research study, the study doctor or his/her staff will discuss all the study details with you. If you and your child decide to participate, they will ask you to sign an Informed Consent document. Please ask as many questions as you need to make sure that you understand the study requirements, as well as the risks and the benefits of participating. You are also welcome to ask questions at any time during the research study.

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