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FF/UMEC/VI

Phase 3

Asthma | Small molecule | Respiratory |Grace Therapeutics, Inc.|Last Updated: Aug 29, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

FF/UMEC/VI · 1 trial · 1 indication

Phase 3 1
NCT04651777Evaluation of Triple Therapy Using Magnetic Resonance Imaging in AsthmaAsthma
ACTIVE NOT_RECRUITING31 Analytics
PHASE3ACTIVE NOT_RECRUITING
Evaluation of Triple Therapy Using Magnetic Resonance Imaging in Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline Airway Function Measured Using 129-Xenon MRI Ventilation Defect Percent at the End of 6 Weeks of Treatment With FF/UMEC/VI 200/62.5/25ug Once Daily
Day 0 to day 42

Change in VDP

Secondary Endpoints

Change From Baseline Forced Expiration Volume in One Second
Baseline and Day 42
Change From Baseline Forced Vital Capacity
Baseline and Day 42
Change From Baseline Residual Volume
Baseline and Day 42
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Participants with poorly controlled moderate to severe asthmaEXPERIMENTALParticipants with poorly controlled moderate to severe asthma will be evaluated during and after a six week trial of triple therapy (ICS/LABA/LAMA) for changes in 129Xe MRI ventilation percent defect, pulmonary function measurements.

Interventions

NameTypeDescription
FF/UMEC/VIDRUGThe investigational drug is a single Ellipta inhaler containing 200 ug fluticasone furoate, 62.5 ug umedlidinium and 25 ug vilanterol. The drug is delivered in an Ellipta inhaler in a single dose once daily.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Participant understands study procedures and is willing to participate in the study as indicated by the participant's signature * Provision of written, informed consent prior to any study specific procedures * Males and females with a clinical diagnosis of eosinophilic asthma ...

Countries:Canada
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Frequently asked questions about FF/UMEC/VI

What is FF/UMEC/VI used for in asthma?

FF/UMEC/VI is an investigational small molecule being developed for the treatment of asthma. It is a triple therapy combination being evaluated in a Phase 3 clinical trial. The drug is not yet approved and remains in clinical development.

Who makes FF/UMEC/VI?

FF/UMEC/VI is being developed by Grace Therapeutics, Inc., a biopharmaceutical company traded under the ticker GRCE. The company is conducting a Phase 3 clinical trial to evaluate the drug in patients with asthma.

What phase is FF/UMEC/VI in?

FF/UMEC/VI is currently in Phase 3 clinical development for asthma. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 3 trial is active but not recruiting participants.

What clinical trials is FF/UMEC/VI in?

FF/UMEC/VI is being studied in a Phase 3 clinical trial with the identifier NCT04651777, titled 'Evaluation of Triple Therapy Using Magnetic Resonance Imaging in Asthma.' The trial is active but not recruiting, with an enrollment of 31 participants in Canada.

Is FF/UMEC/VI the same as other asthma medications?

FF/UMEC/VI is a specific triple therapy combination being developed by Grace Therapeutics, Inc. It is not known to have alternative names. The drug is being studied for its effects in asthma using magnetic resonance imaging in a Phase 3 trial.