Welcome to the DENALI study for asthma in adults
We are conducting a research study looking for people who are currently living with mild asthma to get involved.
While there are several treatment options available to help manage symptoms of mild 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?
DENALI is a clinical study researching 2 doses of budesonide and albuterol inhalation suspension (BDA MDI). This study medication will be compared to budesonide, albuterol, or placebo alone to learn about the safety and effectiveness of the study medication based on improvement in lung function and asthma symptoms after 12 weeks of treatment.
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 mild asthma for at least six months and on stable treatment for at least 30 days
- Taking certain inhaled medications for asthma
- Willing to sign an Informed Consent form
The 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?
The study is divided into 3 time periods: a screening/run-in period, a treatment period, and a safety follow-up period. During the screening period and the treatment period, you will have at least 6 visits with your study doctor at the center. The safety follow-up visit will take place over the telephone.
If the study doctor determines that you meet all of the requirements to be in the study, you will be randomly assigned (like the flip of a coin) to a treatment group. The study site staff will instruct you on how to administer the study medication.
In this study, you will be given an inhaler containing the study drug you are assigned to use daily and a “reliever” Ventolin® inhaler containing albuterol to use for asthma symptoms. No other asthma medications are allowed in the study.
Lab tests, lung tests, and other assessments and questionnaires will be conducted at the in-clinic visits. Not all activities will occur at every visit.
How long will the trial last?
Enrolled patients will be in this study a maximum of 18 weeks and will need to visit the study center at least 6 times over this period.
What do I need to do if I want to discuss participating further?
If you decide that you are interested in participating in the DENALI study, click on the button below to find your nearest center and contact the study staff directly with any further questions you may have.
Every person who participants can have a significant impact on the development of new treatments for people living with asthma.
Thank you for your interest in the DENALI 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.
What is an investigational drug?
An investigational drug is a substance that is being tested in clinical trials. It has been reviewed 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.