A study designed to assess mucociliary clearance after 12 weeks of treatment with dupilumab or placebo
Why is this research study being done?
Many people with asthma have problems with too much mucus (phlegm), but they may not even know because it is stuck deep in their airways. This research study is being done to better identify the people who have a problem with too much mucus/phlegm and to see if some of the newer therapies for asthma, specifically a blocker of Type-2 (T2) immune pathways, can decrease this mucus or improve the ability of the lungs and airways to get rid of the mucus. People with activation of these “T2” pathways can be identified by having higher numbers of eosinophils (a normal blood cell type) in their blood or too much nitric oxide (a gas) in their breath. The drug to be tested is dupilumab (Dupixent) which is an FDA approved drug to treat more severe types of asthma.
Who is eligible for the research study?
Adult asthma patients (over 18 years old) who:
- Require treatment with medium to high doses of inhaled corticosteroids (drugs in Advair, Symbicort, Flovent, Asmanex and many others)
- Who show obstruction on breathing tests that improves with albuterol
- Who have some indication of increases in T2 inflammation in blood or breath tests
- Who do not currently smoke or vape, and have no more than 10 yrs of smoking one or more packs per day prior to quitting if they smoked previously
- Are otherwise generally healthy
What can I expect as part of the research study?
Six visits to the University of Pittsburgh Asthma and Environmental Lung Health Institute (Asthma Institute for short) lasting anywhere from 2 to 4 hours, as well as 5 phone calls with the total time of the research study about 24-25 weeks.
Visit 1. After having the study explained in detail and getting your written consent to participate in the study, we will ask many questions related to your asthma history, draw blood and get breathing tests
Visit 2. If you are eligible after the tests and questions, you will be scheduled for a 2nd visit where you will inhale a small amount of radioactive particles (similar to particles used in a PET scan or some types of cardiac stress tests). We will monitor your lungs abilities to remove the particles over the next few hours until they are removed from your airways.
Visit 3. You will come back a few days later for a CT scan of your lungs and to collect some mucus (sputum) from you.
- You will then be started on a drug call Dupixent or its matching placebo (a “sugar injection that contains no medication). This is an injection-type of drug that you will be taught to inject yourself at home, every 2 weeks for 12 weeks total. The coordinators will call you every 2 weeks to check on you.
Visits 4 and 5. After 12 weeks of treatment you will come back to the Asthma Institute to repeat the radioactive particle scan, undergo a 2nd CT scan and collect more mucus (sputum) on 2 different days. Blood will also be drawn on one of these days and breathing tests will be repeated.
Visit 6. The study will end 4 weeks later with final collection of mucus/sputum, blood and breathing tests.
What do we expect to learn from the study?
We hope to understand the factors which make some people develop more mucus in their lungs, where the mucus is located and how it is removed. We also hope to determine whether a marketed drug for asthma can improve the abilities of the lungs to remove the mucus and how that effect on mucus impacts the symptoms and severity of asthma.