A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD
Baylor College of Medicine is conducting a medical research study for patients with Chronic Obstructive Pulmonary Disease or COPD. Some people refer to COPD as emphysema or smoker’s lung. It is different than asthma. The study is to see if two different types of inhaled treatments have an effect on preventing worsening of COPD symptoms (also called COPD exacerbations) and how well your lungs work (also called lung function).
You decide whether you want to take part or not. If you do not take part, you will lose none of your rights. It will not affect you badly in any way. It will not change the healthcare you receive now or in the future. There is no cost for you to take part in the study. If you have questions about the study, please contact Dr. Nicola Hanania at (713) 873-3454. If you have questions about your rights as a research subject, contact the Institutional Review Board for Human Subject Research for Baylor College of Medicine and Affiliated Hospitals at (713) 798-6970.
The entire study, including time it takes to see if you qualify for the study, lasts approximately 56 weeks but may last as long as 64 weeks. If you qualify, you will receive one of three inhaled treatments for 52 weeks. The study includes approximately eight visits to the office and five phone visits from study staff. You will also have a follow-up phone call 14 days after your last dose of study drug. As with all studies, your health and safety is our main concern. That’s why we’ll monitor your condition closely during regular clinic visits and phone visits. Additionally, we will give you a handheld electronic diary, which will look like an iPhone or an Android smart phone. You will use this eDiary to complete study questions every morning and every evening.