Summary:
Are you controlling your asthma…or is your asthma controlling you?
What is the purpose of the study?
Although there are asthma medications currently available, many people with asthma continue to have a difficult time controlling their symptoms. The purpose of this study is to evaluate an investigational asthma medication to see if it may improve symptoms for adults who have a hard time controlling their asthma with their current medications.
What is the investigational medication?
The investigational medication is called brodalumab. Brodalumab is designed to block the activity of cells that are associated with asthma and is being studied to see if it may help improve asthma control.
Who can participate?
You may be eligible to participate in the study if you:
- Are 18 to 75 years old
- Have been diagnosed with asthma
- Have used an inhaled corticosteroid (ICS) for at least 3 months and have been on a stable ICS dose for at least 30 days
There are other eligibility criteria that the study doctor will review.
What will happen during the study?
Participation in the study may last about 8 months, including a two-week screening period to determine if you are eligible to participate in the study. When you enroll in the study, you will be randomly placed into one of two groups. One group will receive injections of the investigational medication and one group will receive injections of placebo. Placebo injections look like the investigational medication but have no active ingredients. Neither you nor the study doctor will know in which group you have been placed. You will have to visit the study site every 2 weeks for about 6 months to receive injections of the investigational medication or injections of placebo. During the study, you will receive study-required tests and procedures, including blood and urine tests.
What are the potential risks and benefits?
Everyone who participates in a research study must first complete a screening visit. During the screening visit, the study doctor will explain to you the study details and the potential risks and benefits of participation in the study.
The information learned from the study and your participation may help improve future treatment options for people with asthma.
Study participation is voluntary. You do not have to participate in the asthma research study. If you choose to participate, you may leave the study at any time for any reason. The study doctor and staff will be available to help you throughout the study and to address any questions you may have.