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Fluticasone foroate/ vilanterol

Phase 1

Asthma | Small molecule | Respiratory |GSK plc|Last Updated: Aug 21, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Fluticasone foroate/ vilanterol · 1 trial · 1 indication

Phase 1 1
NCT00625196Comparing Two Respiratory Drugs in Combination and Separately From a Novel Inhaler Device in Healthy Japanese SubjectsAsthma
COMPLETED16 Analytics
PHASE1COMPLETED
Comparing Two Respiratory Drugs in Combination and Separately From a Novel Inhaler Device in Healthy Japanese Subjects
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum heart rate
over 4 hours after dosing.
Blood pressure changes
over 12 hours.
Electrocardiogram changes
over 12 hours.
Change in peak expiry flow rate changes
over 24 hours.
Change in serum cortisol concentration changes
over 24 hours

Secondary Endpoints

Change in plasma drug concentration (AUC, Cmax, t1/2, tmax)
over 48 hours after dosing.
Change in blood potassium levels
within 4 hours of drug dosing.
Mean heart rate
over 4 hours after dosing
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Study Design & Arms

AllocationRANDOMIZED
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Subjects receiving fluticasone foroate/ vilanterolEXPERIMENTALEligible subjects will receive single dose of fluticasone foroate/ vilanterol combination treatment 800 micrograms/ 50 micrograms administered using a novel powder inhaler. There will be a washout period of 7 to 10 days between treatments.
Subjects receiving fluticasone foroateACTIVE_COMPARATOREligible subjects will receive single dose of fluticasone foroate 800 micrograms administered using a novel powder inhaler.
Subjects receiving vilanterolACTIVE_COMPARATOREligible subjects will receive single dose of vilanterol 50 micrograms administered using a novel powder inhaler.
Subjects receiving placeboPLACEBO_COMPARATOREligible subjects will receive single dose of placebo administered using a novel powder inhaler.

Interventions

NameTypeDescription
Fluticasone foroate/ vilanterolDRUGFluticasone foroate/ vilanterol 800 micrograms/ 50 micrograms will be available as dry powder inhaler.
Fluticasone foroateDRUGFluticasone foroate 800 micrograms will be available as dry powder inhaler.
VilanterolDRUGVilanterol will be available as dry powder inhaler.
PlaceboDRUGPlacebo will be supplied as dry powder inhaler.
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Eligibility Criteria

Age Range20 Years to 60 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion criteria: * Healthy male adults aged between 20 and 60 years inclusive * Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, and cardiac monitoring. A subject with a clinical abnormality or laboratory p...

Countries:Australia
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Frequently asked questions about Fluticasone foroate/ vilanterol

What is Fluticasone foroate/vilanterol?

Fluticasone foroate/vilanterol is an investigational small molecule combination drug being developed by GSK plc (ticker: GSK) for the treatment of asthma. It is currently in Phase 1 clinical development. The drug is administered via a novel inhaler device and has been studied in a completed clinical trial.

What is Fluticasone foroate/vilanterol used for?

Fluticasone foroate/vilanterol is being developed for the treatment of asthma. It is an investigational combination therapy that has been studied in a Phase 1 clinical trial. The drug is not yet approved and remains in clinical development.

Who makes Fluticasone foroate/vilanterol?

Fluticasone foroate/vilanterol is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The drug is currently in Phase 1 clinical development for the treatment of asthma.

What phase is Fluticasone foroate/vilanterol in?

Fluticasone foroate/vilanterol is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.

What clinical trials is Fluticasone foroate/vilanterol in?

Fluticasone foroate/vilanterol has been studied in one completed Phase 1 clinical trial, identified as NCT00625196. This trial compared the combination drug and its components separately using a novel inhaler device in healthy Japanese subjects. The trial enrolled 16 male participants and was conducted in Australia.

Is Fluticasone foroate/vilanterol the same as fluticasone furoate/vilanterol?

Fluticasone foroate/vilanterol is the drug name used in the clinical trial data. It is a combination of a corticosteroid and a long-acting beta agonist, developed for asthma. The drug is being studied under the name Fluticasone foroate/vilanterol in clinical trials.