Inhalation Treatments for Asthma

(VENTURI Trial)

Overseen By Surya Bhatt, MD, MSPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Alabama at Birmingham

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for individuals with uncontrolled asthma. Participants should have a history of the condition and be currently experiencing symptoms that aren't well-managed by their current treatment.

Inclusion Criteria

Subject's written informed consent obtained prior to any study-related procedure

WOCBP fulfilling criteria for birth control methods

The ability to be trained and correctly use a pressurized Meter Dose Inhaler (pMDI) and Dry Powder Inhaler (DPI)

Exclusion Criteria

Pregnant or lactating female

Milk protein allergy

My condition worsened in the last 3 months.

What Are the Treatments Tested in This Trial?

Interventions

• Beclometasone dipropionate/Formoterol fumarate dihydrate/Glycopyrronium bromide
• Fluticasone furoate/Umeclidinium/Vilanterol

Trial Overview

The VENTURI study is testing two different inhaler medications to see how they affect both large and small airways in asthma patients: Trimbow (a combination of Beclometasone, Formoterol, and Glycopyrronium) and Trelegy Ellipta (combining Fluticasone, Umeclidinium, and Vilanterol).

How Is the Trial Designed?

Group I: Randomized beclomethasone dipropionate/formoterol fumarate /glycopyrrolate Experimental Treatment 1 Intervention

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.

Group II: Cross-Over beclomethasone dipropionate/formoterol fumarate /glycopyrrolate Experimental Treatment 1 Intervention

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.

Group III: Randomized fluticasone furoate/ umeclidinium/vilanterol Active Control 1 Intervention

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. .

Group IV: Wash-Out Active Control 1 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.

Group V: Cross-Over fluticasone furoate/ umeclidinium/vilanterol Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+