HELP US LEARN MORE ABOUT AN ASTHMA INHALER THAT COMES TO THE RESCUE IN MORE WAYS THAN ONE.
TAKE PART in a clinical study using a rescue inhaler that improves symptoms and prevents asthma flare-ups
Study Overview
WATCH OUR VIDEO TO LEARN MORE.
What is the purpose of the DARWIN study?
The DARWIN study aims to help doctors understand how much lung inflammation changes from day to day in people with mild asthma. Some days are better than others, so it makes more sense to give certain medications (like inhaled corticosteroids) only on the days they are needed instead of every day, whether needed or not. The DARWIN study may help show whether a medication called AIRSUPRA® taken as-needed is effective to reduce airway inflammation compared to an albuterol rescue inhaler.
What is the study drug?
AIRSUPRA is a rescue inhaler for asthma containing a combination of albuterol (the active ingredient in a traditional asthma rescue inhaler) and budesonide (an anti-inflammatory commonly used in inhalers for asthma control).
WHO CAN BE IN THE STUDY?
To join the study, participants must:
- Be at least 18 years old
- Have a diagnosis of mild asthma
- Have used a rescue inhaler (such as albuterol) for at least the past year
- Not take inhaled corticosteroids for asthma control (certain other controller medications may be allowed)
We will review your medical history and perform other tests to determine final eligibility.
What is the study drug?
AIRSUPRA is a rescue inhaler for asthma containing a combination of albuterol (the active ingredient in a traditional asthma rescue inhaler) and budesonide (an anti-inflammatory commonly used in inhalers for asthma control).
WHO CAN BE IN THE STUDY?
To join the study, participants must:
- Be at least 18 years old
- Have a diagnosis of mild asthma
- Have used a rescue inhaler (such as albuterol) for at least the past year
- Not take inhaled corticosteroids for asthma control (certain other controller medications may be allowed)
We will review your medical history and perform other tests to determine final eligibility.
Taking Part in the Study
What is involved in the DARWIN study?
Approximately 100 participants will join the study at sites in the United States. It requires only 3 in-clinic visits and 2 remote (tele-health) visits. The study lasts 14-15 weeks and has 2 main parts:
SCREENING & LEAD-IN PERIOD
(2-3 weeks)
Before you begin study treatment, we will review your medical history and you will have testing done to find out if you can join the study. This is called screening. If you don’t meet the screening criteria, the reasons will be explained.
At the end of study screening, you will be provided with a study smartphone app and special equipment to measure your breathing, keep track of asthma symptoms and medications, and to answer study questionnaires. You will use the equipment every day for 2-3 weeks to help make sure the study is a good fit for you. You may choose to use your own smartphone or one provided by the study.
STUDY TREATMENT PERIOD
(12 weeks)
If you qualify at the end of the lead-in period, you will be randomly assigned (like flipping a coin) to study treatment with either AIRSUPRA or albuterol for 12 weeks. You will use your assigned study treatment any time your asthma symptoms might require it instead of your old rescue inhaler.
You will continue to use the study app and the other devices every day during this period to track your asthma symptoms and conduct study procedures. At the end of this period, you will return to the study clinic for a final check on your health and to return the study equipment.
Should I participate in the study?
There is no certainty that you will have any benefit from taking part in the study. The information collected during this study may help doctors better treat patients with asthma in the future. You may also learn more about your asthma through careful tracking of your lung function and symptoms, as well as the additional time spent with study doctors and research staff.
Taking part in a clinical study is completely voluntary. Participation is not required, and if enrolled, you can choose to end your participation at any time and for any reason.
Will the study cost me anything?
Participating in this study will not cost you anything. Study drugs, study visits, and study-related tests and examinations are provided at no cost. You may also be reimbursed for reasonable study-related expenses such as travel or parking.
About Clinical Studies
What is a clinical research study?
A research study is designed to help us learn more about medical devices, drugs, or diagnostic tests.
How are my rights protected?
Every research study is reviewed by an Institutional Review Board (IRB) which helps ensure that the study is conducted safely and that the rights and privacy of study participants are protected. Research studies are conducted by experienced and trained medical professionals who monitor the health of participants throughout the study.