AsthmaPhase 2VENTURINCT07282886
VENTURI (VENTilation Using Respiratory Imaging)
A Phase 2 study testing Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrrolate pMDI and Fluticasone Furoate/Umeclidinium/Vilanterol 100 MCG/1 ACTUATION-62.5 MCG/1 ACTUATION-25 MCG/1 ACTUATION Inhalation Powder in people with Asthma, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrrolate pMDI and Fluticasone Furoate/Umeclidinium/Vilanterol 100 MCG/1 ACTUATION-62.5 MCG/1 ACTUATION-25 MCG/1 ACTUATION Inhalation Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2026to 31 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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:
- 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
- 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).
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Alabama at Birmingham
Birmingham, Alabama, 35233
Elizabeth Plan, RRT, 205-975-5294, epkennedy@uabmc.edu
Surya Bhatt, MD, MSPH, 205-934-5555, sbhatt@uabmc.edu
About this study
Official title: Open-label, Prospective, Crossover, Proof-of-concept Study to Evaluate the Effect of Triple Therapy With Extrafine Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrrolate (BDP/FF/G) Via pMDI Compared With Non-extrafine Fluticasone Furoate/Umeclidinium/Vilanterol (FluF/UMEC/VI) Via DPI on Lung Ventilation and Clinical Outcomes in Subjects With Moderate to Severe Asthma
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
Read the detailed description
The study will comprise of 5 visits. A screening visit (V1, Week -2), with baseline assessment. At the randomization visit (V2, Week 0), patients will be randomized in a 1:1 ratio to receive one of the following treatments for 8 weeks:
- BDP/FF/G 100/6/12.5 mcg pMDI, two inhalations twice-daily
- FluF/UMEC/VI 100/62.5/25 mcg DPI, one inhalation once-daily
A subsequent visit will be performed at 8 weeks (V3), where participants will undergo spirometry, oscillometry, and imaging. Participants will then stop the assigned treatment and undergo a washout period of 4 weeks using an unrelated maintenance ICS/LABA combination inhaler.
Following the washout period, at the next visit (V4, Week 12) participants will then be crossed over to the other treatment they did not receive at randomization.
At the final visit (V5, Week 20), patients will once again undergo spirometry, oscillometry, and imaging. In the event of premature study discontinuation, an early termination (ET) visit will be conducted and the Investigator must fill in the "Study Termination" page in the eCRF, reporting the main reason for withdrawal.
Participants who were previously screened and found ineligible due to transient or correctable conditions (e.g., recent exacerbation) may be considered for rescreening twice. Rescreening must be approved by the Principal Investigator and documented in the subject's screening log.
Rescreening will follow the same procedures as the initial screening, including informed consent, unless otherwise specified in the protocol. The reason for rescreening and any changes in eligibility status must be clearly documented in the case report form (CRF) and source documents.
- Conditions
- Asthma
- Being tested
- 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
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrrolate pMDIDrug
Also called Trimbow, BDP/FF/G
pMDI,100/6/12.5 mcg per inhalation
Fluticasone Furoate/Umeclidinium/Vilanterol 100 MCG/1 ACTUATION-62.5 MCG/1 ACTUATION-25 MCG/1 ACTUATION Inhalation PowderDrug
Also called Trelegy Ellipta, 100 Mcg-62.5 Mcg-25 Mcg/Inh Inhalation Powder, FluF/UMEC/VI
Dry Powder Inhaler,100/62.5/25 mcg per inhalation
| Study group | Role | What they receive |
|---|---|---|
| Randomized beclomethasone dipropionate/formoterol fumarate /glycopyrrolate | Experimental | For this randomized arm, Trimbow pMDI (BDP/FF/G 100/6/12.5 mcg), will be administered as two inhalations twice-daily 8 weeks following randomization. Receives: Drug: Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrrolate pMDI |
| Randomized fluticasone furoate/ umeclidinium/vilanterol | Active comparator | For this randomized arm, Trelegy DPI (FluF/UMEC/VI 100/62.5/25 mcg), will be administered as one inhalation once daily for 8 weeks following randomization. . Receives: Drug: Fluticasone Furoate/Umeclidinium/Vilanterol 100 MCG/1 ACTUATION-62.5 MCG/1 ACTUATION-25 MCG/1 ACTUATION Inhalation Powder |
| Wash-Out | No intervention | Following the 8-week treatment period, participants will be placed on an ICS/LABA therapy unrelated to study medications during a 4-week wash-out period prior to cross-over. |
| Cross-Over beclomethasone dipropionate/formoterol fumarate /glycopyrrolate | Experimental | Following the washout period, participants that were randomized to receive Trelegy DPI (FluF/UMEC/VI 100/62.5/25 mcg) will be crossed over to receive Trimbow pMDI ( BDP/FF/G 100/6/12.5 mcg) for 8 weeks. Receives: Drug: Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrrolate pMDI |
| Cross-Over fluticasone furoate/ umeclidinium/vilanterol | Active comparator | Following the washout period, participants that were randomized to receive Trimbow pMDI( BDP/FF/G 100/6/12.5 mcg) will be crossed over to receive Trelegy DPI (FluF/UMEC/VI 100/62.5/25 mcg) for 8 weeks. Receives: Drug: Fluticasone Furoate/Umeclidinium/Vilanterol 100 MCG/1 ACTUATION-62.5 MCG/1 ACTUATION-25 MCG/1 ACTUATION Inhalation Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Assess pre-post intervention ventilation defect percentage
Measured: 8 weeks
Secondary outcomes (2)
Investigating the association of small airways deposition on lung function
Test pre-post resistance on oscilometry and FEV1
Measured: 8 weeks
Understanding the impact on asthma control using the Asthma Control Test
Test pre-post change in Asthma Control Test
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start15 Mar 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single center, open-label, randomized crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Surya P Bhatt, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07282886
- Sponsor's protocol ID
- IRB-300015310
- Other IDs
- UAB
- Acronym
- VENTURI
- Status last verified
- Apr 2026
- First submitted
- 21 Nov 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Prospective, Crossover, Proof-of-concept Study to Evaluate the Effect of Triple Therapy With Extrafine Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrrolate (BDP/FF/G) Via pMDI Compared With Non-extrafine Fluticasone Furoate/Umeclidinium/Vilanterol (FluF/UMEC/VI) Via DPI on Lung Ventilation and Clinical Outcomes in Subjects With Moderate to Severe Asthma
- ClinicalTrials.gov ID
- NCT07282886
- Acronym / sponsor ID
- VENTURI / IRB-300015310
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The study will comprise of 5 visits. A screening visit (V1, Week -2), with baseline assessment. At the randomization visit (V2, Week 0), patients will be randomized in a 1:1 ratio to receive one of the following treatments for 8 weeks:
- BDP/FF/G 100/6/12.5 mcg pMDI, two inhalations twice-daily
- FluF/UMEC/VI 100/62.5/25 mcg DPI, one inhalation once-daily
A subsequent visit will be performed at 8 weeks (V3), where participants will undergo spirometry, oscillometry, and imaging. Participants will then stop the assigned treatment and undergo a washout period of 4 weeks using an unrelated maintenance ICS/LABA combination inhaler.
Following the washout period, at the next visit (V4, Week 12) participants will then be crossed over to the other treatment they did not receive at randomization.
At the final visit (V5, Week 20), patients will once again undergo spirometry, oscillometry, and imaging. In the event of premature study discontinuation, an early termination (ET) visit will be conducted and the Investigator must fill in the "Study Termination" page in the eCRF, reporting the main reason for withdrawal.
Participants who were previously screened and found ineligible due to transient or correctable conditions (e.g., recent exacerbation) may be considered for rescreening twice. Rescreening must be approved by the Principal Investigator and documented in the subject's screening log.
Rescreening will follow the same procedures as the initial screening, including informed consent, unless otherwise specified in the protocol. The reason for rescreening and any changes in eligibility status must be clearly documented in the case report form (CRF) and source documents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Single center, open-label, randomized crossover
| Arm | Type | Receives |
|---|---|---|
| Randomized beclomethasone dipropionate/formoterol fumarate /glycopyrrolate | Experimental | Drug: Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrrolate pMDIFor this randomized arm, Trimbow pMDI (BDP/FF/G 100/6/12.5 mcg), will be administered as two inhalations twice-daily 8 weeks following randomization. |
| Randomized fluticasone furoate/ umeclidinium/vilanterol | Active comparator | Drug: Fluticasone Furoate/Umeclidinium/Vilanterol 100 MCG/1 ACTUATION-62.5 MCG/1 ACTUATION-25 MCG/1 ACTUATION Inhalation PowderFor this randomized arm, Trelegy DPI (FluF/UMEC/VI 100/62.5/25 mcg), will be administered as one inhalation once daily for 8 weeks following randomization. . |
| Wash-Out | No intervention | –Following the 8-week treatment period, participants will be placed on an ICS/LABA therapy unrelated to study medications during a 4-week wash-out period prior to cross-over. |
| Cross-Over beclomethasone dipropionate/formoterol fumarate /glycopyrrolate | Experimental | Drug: Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrrolate pMDIFollowing the washout period, participants that were randomized to receive Trelegy DPI (FluF/UMEC/VI 100/62.5/25 mcg) will be crossed over to receive Trimbow pMDI ( BDP/FF/G 100/6/12.5 mcg) for 8 weeks. |
| Cross-Over fluticasone furoate/ umeclidinium/vilanterol | Active comparator | Drug: Fluticasone Furoate/Umeclidinium/Vilanterol 100 MCG/1 ACTUATION-62.5 MCG/1 ACTUATION-25 MCG/1 ACTUATION Inhalation PowderFollowing the washout period, participants that were randomized to receive Trimbow pMDI( BDP/FF/G 100/6/12.5 mcg) will be crossed over to receive Trelegy DPI (FluF/UMEC/VI 100/62.5/25 mcg) for 8 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrrolate pMDIAlso: Trimbow, BDP/FF/GpMDI,100/6/12.5 mcg per inhalation | Drug | Cross-Over beclomethasone dipropionate/formoterol fumarate /glycopyrrolate, Randomized beclomethasone dipropionate/formoterol fumarate /glycopyrrolate |
| Fluticasone Furoate/Umeclidinium/Vilanterol 100 MCG/1 ACTUATION-62.5 MCG/1 ACTUATION-25 MCG/1 ACTUATION Inhalation PowderAlso: Trelegy Ellipta, 100 Mcg-62.5 Mcg-25 Mcg/Inh Inhalation Powder, FluF/UMEC/VIDry Powder Inhaler,100/62.5/25 mcg per inhalation | Drug | Cross-Over fluticasone furoate/ umeclidinium/vilanterol, Randomized fluticasone furoate/ umeclidinium/vilanterol |
Primary outcome
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.
Time frame: 8 weeks
Assess pre-post intervention ventilation defect percentage
2 secondary outcomes
Investigating the association of small airways deposition on lung function
Time frame: 8 weeks
Understanding the impact on asthma control using the Asthma Control Test
Time frame: 8 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrrolate pMDI and Fluticasone Furoate/Umeclidinium/Vilanterol 100 MCG/1 ACTUATION-62.5 MCG/1 ACTUATION-25 MCG/1 ACTUATION Inhalation Powder in people with Asthma, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Plan, RRT (205-975-5294, epkennedy@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.