VENTURI Study for Uncontrolled Asthma
This study, called VENTURI, is for people with uncontrolled asthma. It aims to see how two different asthma medications affect your lungs, specifically how well air moves through them. We're comparing Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrrolate (Trimbow) with Fluticasone Furoate/Umeclidinium/Vilanterol (Trelegy Ellipta). Researchers will use a special type of MRI scan called 129Xenon MRI to measure how much of your lung has ventilation defects (areas where air doesn't move well) after 8 weeks of treatment. You can join if you are between 18 and 75 years old and have a confirmed diagnosis of asthma. The study is planned to include 20 participants, but its current status is unclear.
- Study design
- This is an interventional study planning to enroll 20 participants. Participants will be randomly assigned to one of two treatments and then switch to the other treatment later.
- What's involved
- You would have 5 visits over 20 weeks, including screening, randomization, and follow-up appointments. These visits involve procedures like spirometry (a breathing test), oscillometry, and imaging.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants are followed for 20 weeks, with the primary measurement taken at 8 weeks and a final assessment at 20 weeks.
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NCT07282886
VENTURI (VENTilation Using Respiratory Imaging)
Recruiting
PHASE2Ages 18–75InterventionalTreatmentUniversity of Alabama at BirminghamInvestigator-initiated
~20 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrrolate pMDIFluticasone Furoate/Umeclidinium/Vilanterol 100 MCG/1 ACTUATION-62.5 MCG/1 ACTUATION-25 MCG/1 ACTUATION Inhalation Powder
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate the effect of extrafine beclomethasone dipropionate/formoterol fumarate /glycopyrrolate compared with non-extrafine fluticasone furoate/ umeclidinium/vilanterol on ventilation defect percentage utilizing 129Xenon MRI.
Measured over 8 weeks
Conditions
Where it's being run
1 sites across 1 statesAlabama1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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:
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
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
What this trial measures
- Evaluate the effect of extrafine beclomethasone dipropionate/formoterol fumarate /glycopyrrolate compared with non-extrafine fluticasone furoate/ umeclidinium/vilanterol on ventilation defect percentage utilizing 129Xenon MRI.8 weeks
Assess pre-post intervention ventilation defect percentage