GSK TRPV4 Study

Principal Investigator: 

Professor Lorcan McGarvey

Name of the Study:

GSK TRPV4: A placebo-controlled, double-blind (sponsor open), randomised, crossover study to assess the efficacy, safety, and tolerability of GSK2798745 in participants with chronic cough.

Why is this Study important?: 

GlaxoSmithKline is conducting a study (207702) to compare how effective and well-tolerated a potential new medicine called GSK2798745 is for the treatment of chronic cough in adults.

People with chronic cough have a persistent cough lasting for months or years. In some cases, doctors cannot find a reason for the cough (despite performing lots of tests) and treatments do not seem to work. People cough to clear their lungs. This action is triggered by nerve cells. GSK2798745 blocks some of the substances that activate nerve cells in lungs, and so may help prevent coughing.

What is the Research aim?: 

This study will compare GSK2798745 and placebo tablets in two “study sessions”. All participants will have both study sessions, with a rest period of 2 to 3 weeks in between the sessions. In a study session, participants take the study treatment for 7 days. If GSK2798745 is taken in the first study session, placebo is taken in the second. And, if placebo is taken in the first study session, GSK2798745 is taken in the second.

A computer will decide the order in which the study sessions are assigned. Neither the participants nor the study doctor can choose the order or will know which treatment the participant is receiving.

What the Study involves: 

Participants will be in the study for up to 10.5 weeks. Participants will make at least 10 clinic visits, but will also take the study treatment at home on some days. Assessments include: review of medical history and physical examination, electrocardiogram, safety blood tests, hearing test, health questionnaires, and wearing a cough monitor for 24 hours (at the beginning and end of each study session) to measure the number of coughs. Some additional blood samples (PK) will also be collected to measure GSK2798745 levels in the blood

-          Screening Visit = 3 hours: ECG, Spirometer

-          Treatment Period 1 Day -1 = 2 hours

-          Treatment Period 1 Day 1 = 5 hours: ECG

-          Treatment Period 1 Day 7 = 5 hours

-          Treatment Period 1 Day 8 = 2 hours

-          Treatment Period 2 Day -1 = 2 hours

-          Treatment Period 2 Day 1 = 5 hours

-          Treatment Period 2 Day 7 = 5 hours

-          Treatment Period 2 Day 8 = 2 hours: ECG

Follow up Visit or Early Withdrawal = 2 hours: ECG

Who can take part in the Study?:

Participants with chronic cough

Contact Information:

Professor Lorcan McGarvey

Centre for Experimental Medicine

School of Medicine, Dentistry and Biomedical Sciences

Room OG.022

97 Lisburn Road

Belfast

BT9 7BL

Email: l.mcgarvey@qub.ac.uk

Phone: 028 9097 6377

Location:

NI Clinical Research Facility,

U Floor, Belfast City Hospital,

Lisburn Road, Belfast, BT9 7AB

 

Tel:+44 (0)28 9504 0342

Email:NICRF@belfastrust.hscni.net

 
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