The AeroTrial study is divided into four parts, Screening (Visit 1) where you will be evaluated to see if you are eligible to participate further, Randomization/Stabilization (Visits 2-4) where AEROVANT or placebo will be added on to your regular asthma medicines, Treatment Withdrawal (Visits 5-8) where you will be asked to taper off of your regular inhaled steroid therapy while remaining on AEROVANT/placebo as directed by your doctor and Follow-Up (Visit 9) where some safety tests will be completed and you will be discharged.
If you volunteer to participate in this research, you will be asked to do the following during the study:
Screening (Visit 1)
- Share your medical history, including current medicines you take
- Undergo a complete physical examination
- Perform some simple tests to see how well you breathe and how inflamed your lungs are
- Have some standard medical tests for safety (blood and urine tests, blood pressure, etc)
- Be trained on the use of a handheld diary device and peak flow meter that you will take home with you
- Repeat some simple tests to see how well you breathe and how inflamed your lungs are
- Review your daily diary with the doctor
- Provide a blood sample
- Be trained on taking the study medication (AEROVANT or placebo) with the EXAer Inhaler, and receive your first dose in the clinic under the supervision of the staff.
- Repeat some simple tests to see how well you breathe and how inflamed your lungs are
- Review your daily diary with the doctor
- Provide a blood and/or urine sample at some visits
- Repeat some simple tests to see how well you breathe and how inflamed your lungs are
- Review your daily diary with the doctor
- Provide a blood and/or urine sample at some visits
Follow-Up (Visit 9)
- Undergo a complete physical examination
- Perform some simple tests to see how well you breathe and how inflamed your lungs are
- Have some standard medical tests for safety (blood and urine tests, blood pressure, etc)