Do you have asthma and are 18-75 years old? If so, you may be eligible to participate in a research study to help find out if an experimental medication called tezepelumab is a safe and effective treatment for people with asthma. Eligible participants must be non-smokers. Compensation is provided.
Asthma is a chronic lung disease that causes wheezing, breathlessness, chest tightness, and coughing. Although currently available treatments such as inhaled corticosteroids and bronchodilators can help, many people taking these medications still experience asthma-related symptoms.
The purpose of this study is to help researchers find out if an experimental medication called tezepelumab is a safe and effective treatment for people with asthma. Tezepelumab is designed to work with the body’s immune system to block a molecule associated with inflammation. Tezepelumab is not approved by the United States Food and Drug Administration (FDA).
COULD THIS STUDY BE RIGHT FOR YOU?
• Ages 18-75
• Diagnosed with asthma
• Currently using an inhaled steroid medication every day and at least one other daily asthma medication, either as separate inhalers or as a combination product such as Advair, Symbicort, Breo, or Ellipta. (Participants using only an inhaled steroid medication and an albuterol rescue inhaler are not eligible.)
• Not a current smoker
• Former smokers must have a less than 10 pack year history (less than 1 pack a day for ten years or less than 2 packs a day for 5 years). Pack year calculator: https://www.smokingpackyears.com/
• Do not have any other lung disease besides asthma, such as COPD, emphysema, or pulmonary fibrosis
WHAT PARTICIPANTS CAN EXPECT
Participation involves about 12 in-person visits and 3 phone calls over 44 weeks. Some visits may last up to 4 hours. Eligible participants will be randomly assigned (like the flip of a coin) to receive an injection of either tezepelumab or a placebo. A placebo is an inactive substance that looks like the study drug, but does not contain any medication. For the next 28 weeks, participants will have visits every 4 weeks and receive an injection for a total of 7 injections.
Tests and assessments throughout the study may include physical exam, ECG, breathing tests, blood draws, urine collection, questionnaires, paper diaries, CT scans, and bronchoscopy.
Participants will be compensated $125.00 per completed visit.
IRB:20182489 - A Phase 2, Randomized, Double-blind, Parallel Group, Placebo-Controlled Study to Evaluate the Effect of Tezepelumab on Airway Inflammation in Adults with Inadequately Controlled Asthma on Inhaled Corticosteroids and at least one additional asthma controller (CASCADE)
DURATION: About 44 weeks
VISITS: About 12 visits + 3 phone calls
University of Pittsburgh Asthma Institute at UPMC- UPMC Montefiore (Oakland)