Evaluation of Triple Therapy Using Magnetic Resonance Imaging in Asthma

This is an open-label, single arm pilot study in participants prescribed low or medium dose ICS/LABA inhaled therapy and poorly controlled asthma to quantify hyperpolarized 129Xe MRI VDP before and after six weeks of therapy with FF/UMEC/VI 200/62.5/25 ug QD. Male and females between 18 and 70 years of age will provide written informed consent to five visits including screening (Visit 1 week -2), baseline (Visit 2 week 0), mid-study Visit 3 in week 3, study end (Visit 4, week +6) and safety follow-up (Visit 5 week +8). The general study procedures are the same for Visit 1/Day -14, Visit 2/Day 0 and Visit 4/Day 42. Visit 3/Day 21 is an optional clinic visit or phone call. Visit 5 is a phone call check-in for adverse events. For Visits 1, 2 and 4, participants are to withhold their medication as previously described. Vital signs will be recorded at the beginning of the visit. FeNO, spirometry, plethysmography, FOT, MBNW and 129Xe MRI will be performed pre-bronchodilator. FeNO will be performed before all other pulmonary function testing. Following 129Xe MRI, all participants will inhale 4 puffs (100mcg each) of a bronchodilator and quietly rest for 15 minutes. After 15 minutes, participants will undergo post-bronchodilator 129Xe MRI, and once MRI is complete, participants will undergo post-bronchodilator spirometry, plethysmography, FOT and MBNW. SGRQ, ACQ-6 and AQLQ will be administered after post-bronchodilator assessments are completed. For Visit 3, participants who choose to attend an in-person visit are to withhold their medication as described and the process for Visits 1, 2 and 4 will be followed. Participants who choose a phone call Visit 3 will be asked a series of questions regarding their breathing, asthma control and general health and they will complete the SGRQ, ACQ and AQLQ. For all participants, Visit 5 will entail a phone call check-in for adverse events. CT will be acquired at Visit 2, whilst MRI will be acquired on Visits 2, 4 and for those who prefer an in person visit, on Visit 3.