STUDY BASICS
Are you 40-80 years old? Have you been diagnosed with moderate to severe COPD? You may be able to participate in a research study to find out if an investigational study drug can help people who have moderate to severe COPD when given twice a day. Participants may choose to take part in either a 24-week or 48-week study period. Compensation may be provided.
STUDY PURPOSE
Chronic obstructive pulmonary disease (COPD) is a lung disease that makes it hard to breathe. The purpose of this research study is to find out if an investigational study drug can help people with moderate to severe COPD. The study drug has been shown to open airways and slow down inflammation in the lungs, which may make it easier to breathe. The study drug is considered to be investigational because it has not been approved by the US Food and Drug Administration (FDA).
COULD THIS STUDY BE RIGHT FOR YOU?
- Ages 40-80
- Have moderate to severe COPD
- Use an inhaler for your COPD symptoms
WHAT PARTICIPANTS CAN EXPECT
Eligible participants may choose to take part in either a 24-week or 48-week study period. Participants will be randomly assigned (like the flip of a coin) to receive either study drug or placebo. A placebo looks like the study drug but contains no active ingredients. Participants will take the study drug or placebo twice a day using a nebulizer, which will be provided by the study team. Participants will also be asked to keep an electronic diary, have blood draws, and may have a chest X-ray.
IRB: 20202366
- A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ensifentrine over 24 Weeks (With a 48-Week Safety Subset) in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease.MEET THE RESEARCHER
Frank C. Sciurba
Frank C. Sciurba, MD is a Professor of Medicine at the University of Pittsburgh School of Medicine and is the medical director of the Pulmonary Physiology Laboratory in the Division of Pulmonary, Allergy and Critical Care Medicine. Dr. Sciurba’s research has been inspired by real clinical problems facing his patients. He has co-authored over 200 manuscripts and has had National Institutes of Health funding for 20 years including a Specialized Clinical Center of Research Excellence in COPD.