Mechanistic 129-Xe MRI Study of Single Inhaler FF/UMEC/VI Effects in COPD Patients With Persistent, Moderate-severe Dyspnea and/or Poor Health Status With High or Low Risk of Exacerbation
The goal of this study is to study how 12-weeks daily (and optional 48-weeks) single inhaler triple therapy (fluticasone furoate (FF)-an inhaled corticosteroid; umeclidinium (UMEC)-a long-acting muscarinic antagonist; vilanterol (VI)-a long-acting β2-adrenergic agonist) works to treat adults with COPD. The investigators will compare the effects of this medication on adults with COPD who are at low risk of a flare-up and adults with COPD who are at high risk of a flare-up. The main questions it aims to answer are: * Does FF/UMEC/VI improve ventilation defect percent as measured on 129-Xenon MRI in adults with moderate-severe COPD * Evaluate the relationships between the ventilation defect percent and lung function test results Participants will: * Take the inhaler FF/UMEC/VI once daily for 12-weeks (optional 48-weeks) * visit Robarts 2 times (with optional 3rd visit) for tests and imaging
• patient understands study procedures and is willing to participate in the study as indicated by the patient's signature
• provision of written, informed consent prior to any study specific procedures
• males and females 50-85 years of age
• stable COPD, currently on dual therapy LAMA/LABA or ICS/LABA or initial maintenance therapy for at least 3 months
• mMRC score ≥2 and/or CAT score ≥10
• Low risk subgroup: participant has experienced ≤1 exacerbation in the past year and no hospitalizations for COPD High risk subgroup: participant has experienced ≥2 exacerbations in the past year
• Female of childbearing potential (after menarche) must ensure that they are using an effective form of birth control for at least 2 months prior to each imaging visit. Examples of effective birth control include:
‣ True sexual abstinence
⁃ A vasectomized sexual partner
⁃ Implanon®
⁃ Female sterilization by tubal occlusion
⁃ Effective intrauterine device (IUD)/levonogestrel intrauterine system (IUS)
⁃ Depo-Provera™ injections
⁃ Oral contraceptive
⁃ Evra Patch™
⁃ Nuvaring™
• Female permanently sterile due to: 1) documented hysterectomy, 2) documented bilateral salpingectomy, and 3) documented bilateral oophorectomy
• Postmenopausal female: defined as female with no menses for 12 months without an alternative medical cause
• Females of childbearing potential (after menarche) must agree to use a highly effective form of birth control, as defined above, from enrollment, throughout the study duration, and 8 weeks after last dose of study drug, with negative urine pregnancy test taken within 24 hr of any planned CT examination at Visit-1 through Visit 3
• Male participants who are sexually active with a woman who can still have children, must agree to use a double barrier method of contraception (male condom with diaphragm or male condom with cervical cap) from the first dose of the study drug until 8 weeks after last dose