Clinical Trial Opportunity at University Hospitals for Your Patients Who Are Smokers or Former Smokers
October 28, 2019
Investigational drug being studied for use in early manifestations of COPD
UH Clinical Update | October 2019
Recent data published from a NIH-sponsored study demonstrates that up to half of current or former smokers have respiratory symptoms similar to COPD, even when their lung function test results are not bad enough to qualify them for the diagnosis of COPD. Similar to those with COPD, these people may have shortness of breath and difficulty exercising. They may also experience “flare-ups” of their symptoms resulting in treatment with antibiotics or steroids. They may already be on medications used in COPD, even though these medications have never actually been studied in these patients.
Because of this research, published in The New England Journal of Medicine in May 2016, a new NIH-sponsored clinical trial is currently under way, with an arm at UH Cleveland Medical Center led by Rodney Folz, MD, PhD, Division Chief of Pulmonary and Critical Care.
“Based on these findings, the NIH has funded a new clinical trial, named the RETHINC Study (for “REdefining THerapy IN early COPD”),” he says. “The goal of RETHINC is to find out whether bronchodilator medication that helps patients with COPD will also help those who have symptoms of COPD but do not have abnormal enough lung function to qualify for COPD.”
RETHINC is a Phase III, double-blind, placebo-controlled, parallel-design multi-site study comparing indacaterol/glycopyrrolate 27.5/15.6 mcg inhaled twice daily vs placebo in subjects with ≥10 pack-years smoking history with post-bronchodilator FEV1/FVC ≥0.70 and CAT ≥ 10. Treatment duration is 12 weeks. St. George’s Respiratory Questionnaire, the COPD Assessment Test, Baseline Dyspnea Index/Transition Dyspnea Index and spirometry will be performed at baseline and 12 weeks. A phone call at four weeks will assess for adverse events.
This clinical trial is currently enrolling at UH Cleveland Medical Center, focused on recruiting smokers and former smokers between the ages of 40 and 80 who experience cough, phlegm, chest tightness or shortness of breath. Participants are being asked to complete questionnaires and a daily diary detailing symptoms, complete study-related procedures, including physical examination(s) and lung function tests and return to UH Cleveland Medical Center twice during the 12 week treatment phase of the study. They’re also being asked to take an investigational bronchodilator as required by the study protocol.
For more information on this clinical trial or to refer a patient, please call 216-844-2479 or email Lung@UHhospitals.org. Participants will get a free spirometry test. If individuals qualify for participation, study medication will be provided free of cost during the 12-week study period.