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GW685698X Morning

Phase 2

Asthma | Small molecule | Respiratory |GSK plc|Last Updated: Sep 15, 2016

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment669

FDA Designations

No designations recorded

Clinical trial landscape

GW685698X Morning · 1 trial · 1 indication

Phase 2 1
NCT01499446A Study of GW685698X 100mcg Administered Once Daily Either in the Morning or the Evening and GW685698X 250mcg Administered Once Daily in the Evening Via DISKHALER for 28 Days in Subjects With Persistent Bronchial Asthma.Asthma
COMPLETED669 Analytics
PHASE2COMPLETED
A Study of GW685698X 100mcg Administered Once Daily Either in the Morning or the Evening and GW685698X 250mcg Administered Once Daily in the Evening Via DISKHALER for 28 Days in Subjects With Persistent Bronchial Asthma.
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Peak expiratory flow (PEF)
28 days

Mean change from baseline in daily trough (pre study treatment and pre bronchodilator) PEF during the 28 day treatment period with GW685698X 100mcg once daily in the morning compared with GW685698X 100mcg once daily in the evening by inhalation via DISKHALER.

Secondary Endpoints

Peak expiratory flow (PEF)
28 days
PEF
28 days
Clinic lung function
28 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GW685698X (fluticasone furoate) 100mcg MorningEXPERIMENTAL -
GW685698X (fluticasone furoate) 100mcg EveningEXPERIMENTAL -
GW685698X (fluticasone furoate) 250mcg EveningEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
GW685698X (fluticasone furoate) 100mcg MorningDRUGGW685698X inhaled once daily in the morning plus placebo in the evening for 28 days
GW685698X (fluticasone furoate) 100mcg EveningDRUGGW685698X inhaled once daily in the evening fplus placebo in the morning for 28 days
GW685698X (fluticasone furoate) 250mcg EveningDRUGGW685698X inhaled once daily in the evening plus placebo in the morning for 28 days
PlaceboDRUGPlacebo inhaled twice daily (morning and evening) for 28 days
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Eligibility Criteria

Age Range16 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites64

Inclusion Criteria: * Outpatients aged between 16- 65 years. * Male and female; female subjects must be non-child bearing potential or of childbearing potenetial with negative pregnancy test and willing to use acceptable contraceptive methods * Documented clinical history of persistent asthma first...

Countries:BrazilBulgariaChileCroatiaEstoniaGermanyGreeceHungaryItalyMexicoRomaniaRussiaSouth Africa
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Frequently asked questions about GW685698X Morning

What is GW685698X Morning used for in asthma?

GW685698X Morning is an investigational small molecule being studied for the treatment of persistent bronchial asthma. It is administered once daily via the DISKHALER device. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

What does GW685698X Morning target?

GW685698X Morning is a small molecule developed for asthma, but its specific molecular target has not been disclosed in available information. The drug is being evaluated for its efficacy and safety in patients with persistent bronchial asthma through clinical trials.

Who makes GW685698X Morning?

GW685698X Morning is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with asthma.

What phase is GW685698X Morning in?

GW685698X Morning is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied for the treatment of persistent bronchial asthma.

What clinical trials is GW685698X Morning in?

GW685698X Morning has one completed Phase 2 clinical trial, NCT01499446, which enrolled 669 participants with persistent bronchial asthma. The study was randomized, double-blind, and placebo-controlled, evaluating the drug administered once daily in the morning or evening for 28 days.

Is GW685698X Morning the same as GW685698X?

GW685698X Morning is a specific dosing regimen of the investigational drug GW685698X, referring to administration in the morning. The clinical trial NCT01499446 compared morning and evening dosing of GW685698X to assess the impact of dosing time on efficacy and safety in asthma patients.