RETHINC: REdefining Therapy IN early COPD

STUDY BASICS

Are you a current or former smoker aged 40-80 with a history of 20 or more pack years? Do you frequently experience cough, phlegm, or shortness of breath? You may be able to participate in a research study to help find out if an FDA-approved bronchodilator (an inhaler used to open the airways) can help current or former smokers who frequently experience breathing problems. Compensation provided.

STUDY PURPOSE

Smoking cigarettes increases the risk of developing lung disease and other health problems. Chronic obstructive pulmonary disease (COPD) is a lung disease that makes it hard to breathe and causes shortness of breath, frequent coughing, and the production of mucus or phlegm. Some people may have these types of symptoms, but are not diagnosed with or treated for COPD because they do not meet the current criteria for COPD based on lung function testing. The purpose of this study is to find out if an inhaled medication can help current or former smokers who do not meet the current criteria for COPD but still frequently experience breathing problems. The study drugs used in the bronchodilator (indacaterol/glycopyrrolate) are approved to treat people with COPD but are considered to be investigational in people who do not meet the current criteria for COPD based on their breathing tests. Researchers hope their findings will lead to improved treatments for people with lung disease.

COULD THIS STUDY BE RIGHT FOR YOU?

• Ages 40-80
• Current or former smoker, with a smoking history of at least 20 “pack years” (To figure out your pack years, multiply how many packs a day you smoke by how many years you have smoked. For example, 20 pack years is equal to 1 pack per day for 20 years, or 2 packs per day for 10 years.)
• Frequently experience cough, phlegm, chest tightness, or shortness of breath
• Willing to temporarily discontinue all inhaled medications, except for short-acting “rescue” inhalers such as Albuterol, ProAir, Proventil, and Ventolin

WHAT PARTICIPANTS CAN EXPECT

Participation involves up to 3 visits lasting 4-6 hours each over 12 weeks. Participants will have a physical exam and lung function tests, complete questionnaires and a daily health and medication diary, and receive phone calls from the study team. It is important to know that participants will be randomly assigned (like the flip of a coin) to receive either the investigational study drug (bronchodilator) or a placebo. A placebo looks like the study drug but does not contain any drug.