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Sponsor: University of Alabama at Birmingham
Conditions: Asthma
Interventions: Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrrolate pMDI, Fluticasone Furoate/Umeclidinium/Vilanterol 100 MCG/1 ACTUATION-62.5 MCG/1 ACTUATION-25 MCG/1 ACTUATION Inhalation Powder
Countries: United States
The purpose of the study is to enroll participants with uncontrolled asthma to evaluate the large and small airways and drug delivery utilizing two study drugs: * Beclometasone dipropionate/Formoterol fumarate dihydrate/Glycopyrronium bromide (BDP/FF/G) or Trimbow * Fluticasone furoate/Umeclidinium/Vilanterol (FluF/UMEC/VI ) or Trelegy Ellipta
Sex: ALL
Age: 18 Years to 75 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Subject's written informed consent obtained prior to any study-related procedure. * Patients aged ≥ 18 and ≤ 75 years * Confirmed diagnosis of asthma (patients must have a documented history of asthma for at least 1 year with diagnosis before the age of 40 and/or pre-bronchodilator FEV1 between 50-80% of their predicted normal value, after appropriate washout from bronchodilators) * Symptomatic on ICS/LABA treatment with ACT \<20 * No exacerbations in the past 3 months requiring treatment with systemic corticosteroids or emergency department visit/ in-patient hospitalization * The ability to be trained and correctly use a pressurized Meter Dose Inhaler (pMDI) and Dry Powder Inhaler (DPI) * To have a cooperative attitude and the ability to perform the required outcomes measurements (e.g. spirometry maneuvers in sitting and supine position) and the ability to understand the risks involved * WOCBP fulfilling one of the following criteria: 1. WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the follow-up visit or 2. WOCBP with physician confirmed non-fertile male partners (contraception is not required in this case). * Female patients of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile, e.g. amenorrheic for ≥12 consecutive months without alternative medical cause). Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. If indicated, as per investigator's request, post-menopausal status may be confirmed by follicle-stimulating hormone levels (according to local laboratory ranges). Exclusion Criteria: * Pregnant or lactating female * Patients who had an exacerbation, defined as a sustained and acute deterioration of subject's symptoms and signs (dyspnea, cough and/or sputum production/purulence) that was either moderate, i.e. require treatment with systemic (oral/IV/IM) corticosteroids and/or antibiotics, or severe, i.e. require hospitalization, if their associated treatment/hospitalization occurred within 3 months prior to V1 * Inability to carry out pulmonary lung function testing, to comply with study procedures or with study treatment intake * History of near fatal asthma or of a past hospitalization for asthma in intensive care unit which, in the judgement of the Investigator, may have placed the patient at undue risk * Patients using systemic corticosteroid medication in the 4 weeks or slow-release corticosteroids in the 12 weeks, prior to screening * Patients who suffer from COPD as defined by the current Global Initiative for Chronic Obstructive Lung Disease (GOLD) document * History of a diagnosis of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease which may have interfered with study evaluations * Current smokers or current use of electronic cigarettes or ex-smokers with total cumulative exposure equal or more than 10 pack-years or having stopped smoking one year or less prior to screening visit * Patients who had clinically significant cardiovascular condition according to investigator's judgement, such as but not limited to: congestive heart failure (NYHA class \>2), acute ischemic heart disease in the last year prior to study screening, history of sustained cardiac arrhythmias or sustained and non-sustained cardiac arrhythmias diagnosed in the last 6 months (sustained meant lasting more than 30 seconds or ending only with external action, or led to hemodynamic collapse; non-sustained meant \>3 beats \<30 seconds, and or ending spontaneously, and or asymptomatic), high degree impulse conduction blocks (\>2nd degree atrioventricular block type 2). Similarly, patients affected by persistent, long standing or paroxysmal AF were not considered for enrollment * Patients who are unable to undergo imaging procedures for CT scans or MRI or demonstrate intolerance to Xenon gas * Patients who have participated in a recent therapeutic trial (within past 6 months) * Patients who have a milk protein allergy
- Birmingham, Alabama, United States