Understanding Asthma
Asthma is a condition that causes your airways to become swollen and inflamed. This inflammation makes your airways narrower and can cause shortness of breath, coughing, wheezing or whistling when you breathe, and a tight feeling in your chest.
Over time, asthma can cause the walls of your airways to thicken. This means the space inside your airways gets smaller, which can make it even more difficult to breathe. This is more likely to happen if your symptoms are not well-controlled.
Certain medicines can be used to help keep asthma symptoms under control. Devices called inhalers allow you to breathe in, or inhale, medicine(s) and deliver them directly to the airways where they are needed. The three main types of preventative long-term asthma medications are inhaled corticosteroids (ICS), long-acting beta agonists (LABA), and long-acting muscarinic antagonists (LAMA).
About the KALOS Study
THE KALOS study is evaluating if a new type of inhaler called BGF MDI may provide benefit for people whose asthma symptoms are not fully controlled using their current inhaler treatment. Researchers will compare BGF MDI against BFF MDI (a similar investigational inhaler) and Symbicort ® (an approved treatment for asthma) to see if it is better, worse, or the same at controlling asthma symptoms. This study will also help us learn more about asthma and other associated conditions.
What Are the Study Treatments?
BGF is an investigational metered dose inhaler (MDI) that sprays a specific combination of the medicines budesonide, glycopyrronium and formoterol fumarate into the airways. These three medicines are designed to work together to reduce inflammation, relax the muscles in the airway, and help keep the airways open.
Two different dose levels of BGF will be compared against:
- BFF, a similar investigational MDI containing the medicines budesonide and formoterol fumarate, and
- Symbicort®, an approved pressurized metered dose inhaler (pMDI) containing budesonide and formoterol fumarate.
Why Participate?
Before a potential treatment for asthma can be approved, it must first be tested in a series of clinical trials. By choosing to volunteer for this study, you or your child can help us learn more about how the BGF MDI works. The findings from this study may lead to better treatment options and help other people with asthma in the future.
Who Can Participate?
This study may be an option for people who:
- Are 12 to 80 years old
- Have been diagnosed with asthma for at least one year
- Have been using the same dose of ICS/LABA (inhaled corticosteroid/ long-acting beta agonist) inhaler medication every day for at least four weeks
There are other requirements to join this clinical study. A study team member will help determine if this study is right for you or your child based on all participation criteria.
What To Expect
This study is split into three periods: Screening, Treatment, and Follow-Up:
Screening (4 weeks)
The screening period will determine if this study is a good fit for you or your child. Over the course of four weeks, participants will be asked to attend four clinic appointments for various tests and assessments, including a physical exam, lung function tests, heart tests, urine samples, and blood draws.
Treatment (24-52 weeks)
Participants who meet the screening criteria will enter the treatment period of the study for up to 52 weeks (one year). A computer will randomly assign participants to one of four possible groups to receive one of the following treatments:
- BGF MDI budesonide 320 μg / glycopyrronium 28.8 μg / formoterol fumarate 9.6 μg taken as 2 puffs twice a day (morning and evening)
- BGF MDI budesonide 320 μg / glycopyrronium 14.4 μg / formoterol fumarate 9.6 μg taken as 2 puffs twice a day (morning and evening)
- BFF MDI budesonide 320 μg / formoterol fumarate 9.6 μg taken as 2 puffs twice a day (morning and evening)
- Symbicort® budesonide 320 μg / formoterol fumarate dihydrate 9 μg taken as 2 puffs twice a day (morning and evening)
Neither participants nor the study doctor will know what has been assigned. During the treatment period, participants will need to use the study inhaler twice a day and attend 7-11 clinic appointments. Participants will also need to record their asthma symptoms at home in an eDiary (a handheld electronic device) and measure their lung function using a peak flow meter (a small device that you blow air into). The study team will provide the eDiary and peak flow meter and instruct participants on their use.
Participants may be asked to take part in three additional sub-studies. These are completely optional. Participants who choose to take part in the sub-studies will need to complete a few extra tests and questionnaires.
Follow-Up (2 weeks)
Participants will have a follow-up phone call two weeks after their last dose of the study treatment so the study team can continue to monitor their health and well-being.