Welcome to the MANDALA study for asthma in adults
We are conducting a research study looking for people who are currently living with moderate to severe asthma to get involved.
While there are several treatment options available to help manage symptoms of moderate to severe asthma, they don’t always work well for everyone, which is why we are working hard to expand our knowledge of this chronic lung disease and improve available treatments. These studies are important for medical advances and current treatments for diseases are only available because of research study volunteers.
What is the purpose of this study?
MANDALA is a research study that will look at the safety and efficacy of the investigational drug (study medication), in comparison to an existing treatment to relieve symptoms in adults with moderate to severe asthma. 2 doses of budesonide and albuterol inhalation suspension (BDA MDI) will be compared to an albuterol metered dose inhaler (albuterol MDI). Safety and efficacy of BDA MDI will be compared with albuterol MDI to relieve symptoms in adults with moderate to severe asthma.
Who can participate in this study?
To be eligible for this study, you must be:
- At least 18 years of age or older
- Diagnosed with moderate to severe asthma
- Willing to sign an Informed Consent form
- Have a documented exacerbation in the last 12 months
Your study doctor will review other study requirements with you to confirm if you qualify, including discussing any treatments you are currently using.
What can I expect if I decide to participate?
If enrolled in the study, you will be randomly assigned to 1 of 3 treatment groups. Neither you nor your study doctor will know the treatment group to which you are assigned. This is normal in randomized clinical studies and works as a measure to protect the study outcomes.
- BDA MDI 80/180 μg as needed
- BDA MDI 160/180 μg as needed
- Albuterol MDI 180 μg as needed
During the study, site staff will instruct you on how to administer the study drug. Then…
- You will visit the study site at least nine times over a minimum 6-month period, with possible additional visits every 3 months until the study is completed
- Another visit will be required if you complete the study early for any reason
- You will receive a follow-up phone call 2 weeks after the end of the study
- Lab tests, a physical exam, and other assessments and questionnaires will be conducted at the in-clinic visits. (Not all activities will occur at every visit)
If you ever have any questions, you can talk to your study doctor. In addition, please note that you reserve the right to withdraw from the study at any point.
How long will the trial last?
The study will consist of these time periods and clinic visits as follows:
About 2 to 4 weeks (14 to 28 days)
At least 24 weeks and up to 36 weeks
What do I need to do if I want to discuss participating further?
If you decide that you are interested in participating in the MANDALA study, click on the button below to see if you may qualify. If you are eligible you will be able to find your nearest study center, and contact the study staff directly with any further questions you may have.
Every person who participates can have a significant impact on the development of new treatments for people living with asthma.
Thank you for your interest in the MANDALA study
What is a clinical trial?
A clinical trial is a scientific study in which participants are assigned to one or more investigational drugs to answer questions about the treatment to see if it works, works better than other treatments, and has side effects. Pharmaceutical companies use clinical research studies like this one to learn more about investigational medications before they are made available to the public.
What is an investigational drug?
An investigational drug is a substance that is being tested in clinical studies or trials. It has been approved by an ethics committee for testing in people, and may or may not be approved by the government health agency for treatment for this condition.