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GSK159797

Phase 2

Pulmonary Disease, Chronic Obstructive | Small molecule | Respiratory |GSK plc|Trials Updated: Oct 28, 2016

GSK159797 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jul 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment74

FDA Designations

No designations recorded

GSK159797 clinical trials

GSK159797 · 2 trials · 1 indication

Phase 2 2
NCT00358488Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic PatientsPulmonary Disease, Chronic Obstructive
COMPLETED54 Analytics
NCT00354666Single Doses GSK159797 On Patient Safety And Lung Function In Patients With Mild To Moderate AsthmaPulmonary Disease, Chronic Obstructive
COMPLETED20 Analytics
PHASE2COMPLETED
Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients
Pulmonary Disease, Chronic ObstructiveUnlock trial analytics
PHASE2COMPLETED
Single Doses GSK159797 On Patient Safety And Lung Function In Patients With Mild To Moderate Asthma
Pulmonary Disease, Chronic ObstructiveUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean change from baseline in trough FEV1
after 14 day repeat doses
Safety and tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and side effects.

Secondary Endpoints

Mean change from baseline in trough FEV1
after a single dose
Change from baseline in weighted mean FEV1 0-2 hours, 0-4 hours, 0-24 hours
Day 1 and Day 14
Effects on the lung at 12 and 24hrs Effects on the heart, blood pressure and pulse rate at 8hrs Changes in the amount of glucose and potassium in the blood 4 and 8hrs Amount of drug in the body (blood and urine).
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GSK159797 (10, 15, and 20mcg)EXPERIMENTALGSK159797 (10, 15, and 20mcg)
salbutamolEXPERIMENTALsalbutamol
salmeterol 50mcgEXPERIMENTALsalmeterol 50mcg
placeboPLACEBO_COMPARATORplacebo

Interventions

NameTypeDescription
GSK159797 (10, 15, and 20mcg)DRUGGSK159797 (10, 15, and 20mcg)
salbutamolDRUGsalbutamol
salmeterol 50mcgDRUGsalmeterol 50mcg
placeboDRUGplacebo
GSK159797DRUG -
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Eligibility Criteria

Age Range18 Years to 70 Years
SexFEMALE
Healthy VolunteersNo
Study Sites6

Inclusion criteria: * Subjects with documented history of persistent asthma using corticosteroids at a total daily dose of 200 to 200mcg of FP or equivalent corticosteroid * Female subjects only using acceptable birth control method * Non-smokers * FEV1 between 60 and 90% predicted * Increase in FE...

Countries:GermanyNetherlandsRussiaSwedenUnited Kingdom
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Frequently asked questions about GSK159797

What is GSK159797?

GSK159797 is an investigational small molecule developed by GSK plc for chronic obstructive pulmonary disease (COPD), a respiratory condition. It has been studied in Phase 2 clinical trials. It is not described as an approved medicine and remains in clinical development.

What is GSK159797 used for in COPD?

GSK159797 has been studied for pulmonary disease, chronic obstructive, the respiratory condition commonly called COPD. Its clinical trials enrolled adults with COPD or asthma to assess safety and lung function. It is investigational and has not been established as a marketed treatment for COPD.

Who makes GSK159797?

GSK159797 is developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 2 studies of the compound in patients with respiratory disease, including chronic obstructive pulmonary disease and asthma.

What phase is GSK159797 in?

GSK159797 is in Phase 2 development. Two Phase 2 trials have been completed, and no trials are currently active. The studies together enrolled 74 participants. The drug is investigational and is not described as FDA approved.

What clinical trials is GSK159797 in?

GSK159797 has been studied in two completed Phase 2 trials: NCT00358488, which investigated repeat doses in asthmatic patients across Germany, the Netherlands, Russia, Sweden and the United Kingdom, and NCT00354666, which tested single doses for patient safety and lung function in mild to moderate asthma.