207702 Effect of GSK2798745 in participants with chronic cough
Research type
Research Study
Full title
A placebo-controlled, double-blind (sponsor open), randomised, crossover study to assess the efficacy, safety, and tolerability of GSK2798745 in participants with chronic cough
IRAS ID
228844
Contact name
Piyush Mehta
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Ltd.
Eudract number
2017-002265-21
Duration of Study in the UK
1 years, 4 months, 0 days
Research summary
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.
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.
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.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
17/NW/0635
Date of REC Opinion
12 Jan 2018
REC opinion
Further Information Favourable Opinion