What we are studying
The purpose of this study is to determine: 1) if QAW039 works better than placebo when taken with your usual asthma medicines, 2) if QAW039 reduce the number of asthma attacks you have, improve your asthma symptoms, and improve your quality of life, 3) if you have any side effects when you are taking the study medication.
About 846 patients with severe asthma aged 12 years and older will join in this study at about 200 study sites in countries all over the world. Patients will be separated into two groups based on their eosinophil (a type of blood cell) count. About two thirds of patients out of the 846 patients in the study will be in one group, and the other third will be in the second group. About 127 patients out of the 846 patients in this study (15%) will be 12 to 17 years old.
All patients will receive placebo during the study. There is about a 2 in 3 chance (66%) that you will receive QAW039 study medicine in addition to placebo during the study. There is about a 1 in 3 chance (33%) that you will receive only placebo during the entire study. A placebo is used to make sure that the changes you report are not happening just by chance.
Study medication will be provided to you in bottles. If you take part in this study you will need to take 2 tablets of study medication every day in the morning for the entire study. You will take one tablet from one bottle and one tablet from the other bottle every morning between 6:00 a.m. and 10:00 a.m., with a liquid, with or without food, except on the morning of your office visits. The morning of your office visits you will not take any study medication until after you have been seen by the Study Doctor.
If at any time during the study the doctor feels that it would not be in your best interest to continue, you will be taken out of the study. Novartis as a sponsor of this study has a right to stop this study and withdraw you from the study at any time.
You and your doctor will not know what you have been given, but your doctor can find out what you were taking if there is an emergency.
In addition to usual daily asthma medication, you will also be allowed to use an inhaler of so- called rescue medication (for example: salbutamol or albuterol). You be able to use it whenever you need to, for the rest of the study.
If you join the study you will be asked to come to the doctor’s office/clinic/study site 11 times over about 60 weeks (14 months). Most study visits will take about 1 to 2 hours, but 4 visits will take more than 2 hours, so that tests can be done about 2 hours after you have taken study medicine at the office/clinic/study site. You will also have 6 telephone call “visits” from the study coordinator or Study Doctor.
$1,225 for completing all study visits. You will be paid for each complete visit if you withdraw for any reason from the study. Visit 1, 201, 202, 205, 299: $100. Visit 101, 199, 203, 204, 206, 207: $75. 6 Telephone calls: $25 each. Follow-up visit $50.