Asthma 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.

To be eligible for this study, you must be:

• Must be between ages 4 - 11 years old
• 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.

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.

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