VENTURI (VENTilation Using Respiratory Imaging)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT07282886
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrrolate pMDI — DRUG
    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 Powder — DRUG
    Dry Powder Inhaler,100/62.5/25 mcg per inhalation

Study Details

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

Key Dates

Start date
Mar 15, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Randomized beclomethasone dipropionate/formoterol fumarate /glycopyrrolate
    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.
  • Active Comparator: Randomized fluticasone furoate/ umeclidinium/vilanterol
    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. .
  • No Intervention: Wash-Out
    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.
  • Experimental: Cross-Over beclomethasone dipropionate/formoterol fumarate /glycopyrrolate
    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.
  • Active Comparator: Cross-Over fluticasone furoate/ umeclidinium/vilanterol
    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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Alabama at BirminghamBirminghamAlabama35233
Elizabeth Plan, RRT
[email protected]
205-975-5294
Surya Bhatt, MD, MSPH
[email protected]
205-934-5555
Surya Bhatt, MD, MSPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Asthma
By specialty
PulmonologyLung disease
By research site
The University of Alabama at Birmingham· Birmingham, AL

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