We are conducting the INSIGHT COPD study because symptoms of chronic obstructive pulmonary disease (COPD) and high body mass index (BMI) overlap. There are many medications for patients with COPD, but there is little mention of weight loss as a possible treatment in current research. We are trying to find out if a lifestyle program that promotes modest weight loss and increased physical activity will improve COPD symptoms and lead to better exercise tolerance for those with a high BMI. We are also looking at the effects on shortness of breath, quality-of-life, and cardiovascular disease risk factors. The INSIGHT COPD trial is taking place at many sites across the United States including MUSC, and is planning to enroll approximately 1000 people.
This is an observational, unblinded, single group study. All study participants will be provided with the COPD Co-PilotTM application, as well as a peak flow meter and device for accessing the application. Patients will be trained in use of the application and phone device by a health care professional. Patient records including costs will be collected during the study, to include clinic visits, admissions, and emergency department visits and collected retrospectively from January 1, 2015 through enrollment. All analysis of patient compliance and utilization parameters will be completed retrospectively.
Individuals with alpha-1 antitrypsin (AAT) deficiency (AAT blood level lower than 11 micro-moles) and emphysema will be invited to participate in this study. This study will determine the impact of IV Alpha-1 proteinase inhibitor (Alpha-1 MP) on the progression of emphysema in patients with AAT deficiency. A participant in this study would receive any one of the following three therapies: 1) Alpha-1 MP dosed at 60mg/Kg, 2) Alpha-1 MP dosed at 120mg/Kg, or 3) Placebo. Once a subject is enrolled into this study, he/she will be randomly selected to receive only one of the above three therapies. Neither the study investigators nor the participants will know the actual therapy being given to the participants. All the study participants will receive serial chest CT scans to determine if their emphysema progresses over the following 3 years. Participants will have the IV therapies given to them weekly, with some infusions given at MUSC and some at home. Safety and side effects of all therapies will be monitored.