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GSK159797

Phase 2

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

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

Clinical trial landscape

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 used for?

GSK159797 is an investigational small molecule being studied for the treatment of chronic obstructive pulmonary disease (COPD). It is in Phase 2 clinical development and has been evaluated in patients with mild to moderate asthma as well, though its primary focus is on respiratory conditions.

Who makes GSK159797?

GSK159797 is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to assess the drug's safety and efficacy in respiratory diseases.

What phase is GSK159797 in?

GSK159797 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. Two Phase 2 trials have been completed to evaluate its effects in patients with respiratory conditions.

What clinical trials has GSK159797 been in?

GSK159797 has been studied in two completed Phase 2 clinical trials. NCT00354666 investigated single doses in patients with mild to moderate asthma, and NCT00358488 examined repeat doses in asthmatic patients. Both trials were randomized, double-blind, and placebo-controlled, with a combined enrollment of 74 participants.

Is GSK159797 the same as any other drug?

GSK159797 is a distinct investigational compound with no alternative names listed. It is being developed specifically for respiratory indications and is not known to be identical to any other marketed or investigational drug.