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GW870086

Phase 2

Asthma | Small molecule | Respiratory |GSK plc|Last Updated: Dec 1, 2016

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment136

FDA Designations

No designations recorded

Clinical trial landscape

GW870086 · 1 trial · 1 indication

Phase 2 1
NCT01245426A Study in Asthmatics to Determine the Efficacy and Dose Response of Repeat Doses of GW870086X on Forced Expiratory Volume in 1 Second (FEV1)Asthma
COMPLETED136 Analytics
PHASE2COMPLETED
A Study in Asthmatics to Determine the Efficacy and Dose Response of Repeat Doses of GW870086X on Forced Expiratory Volume in 1 Second (FEV1)
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline associated with GW870086X versus placebo at Day 28 on FEV1
Day 28

Secondary Endpoints

Change from baseline in FEV1 on Day 7, Day 14 and Day 21
Days; 7, 14, 21
Change from baseline in peak expiratory flow rate (PEFR) measured twice daily over 28 days
Days 1-28
Rescue medication usage
Days 1-28
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GW870086 2mgEXPERIMENTALGW870086 2mg once daily in the morning for 27 ± 2 days
GW870086 4mgEXPERIMENTALGW870086 4mg once daily in the morning for 27 ± 2 days
PlaceboPLACEBO_COMPARATORPlacebo once daily in the morning for 27 ± 2 days
GW870086 1mgEXPERIMENTALGW870086 1mg once daily in the morning for 27 ± 2 days
GW870086 3mgEXPERIMENTALGW870086 3mg once daily in the morning for 27 ± 2 days

Interventions

NameTypeDescription
GW870086 2mgDRUGoral inhalation
GW870086 4mgDRUGoral inhalation
GW870086 PlaceboDRUGoral inhalation
GW870086 1mgDRUGoral inhalation
GW870086 3mgDRUGoral inhalation
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Male or female between 18 and 65 years * A female subject is eligible to participate if she is of: Non-childbearing potential. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to discontinue HRT to allow confirmation of post...

Countries:BulgariaGermanySouth Africa
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Frequently asked questions about GW870086

What is GW870086 used for?

GW870086 is an investigational small molecule being developed for the treatment of asthma. It is a respiratory therapeutic that has been studied in patients with asthma to evaluate its effect on lung function, specifically forced expiratory volume in 1 second (FEV1).

Who is developing GW870086?

GW870086 is being developed by GSK plc, a global biopharmaceutical company. GSK plc is listed on the stock exchange under the ticker symbol GSK.

What phase is GW870086 in?

GW870086 is in Phase 2 clinical development. It has completed a Phase 2 clinical trial in patients with asthma, and it remains an investigational drug that has not been approved for commercial use.

What clinical trials is GW870086 in?

GW870086 has been studied in one completed Phase 2 clinical trial, identified as NCT01245426. This trial evaluated the efficacy and dose response of repeat doses of GW870086X on forced expiratory volume in 1 second (FEV1) in asthmatics. The study enrolled 136 participants and was conducted in Bulgaria, Germany, and South Africa.

Is GW870086 the same as GW870086X?

GW870086 is also known as GW870086X. The clinical trial NCT01245426 refers to the drug as GW870086X, indicating that these names refer to the same investigational compound.