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.
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.
To be eligible for this study, you must be:
Your study doctor will review other study requirements with you to confirm if you qualify, including discussing any treatments you are currently using.
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.
During the study, site staff will instruct you on how to administer the study drug. Then...
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.
The study will consist of these time periods and clinic visits as follows:
Screening period: About 2 to 4 weeks (14 to 28 days)
Treatment period: At least 24 weeks and up to 36 weeks