Phase II Open-label Pilot Study of V3381 in Chronic Cough
Research type
Research Study
Full title
Phase II Open-label Pilot Study of V3381, a Novel N-Methyl-D-Aspartate Receptor Antagonist, in Chronic Cough Patients attending a Specialist Clinic
Contact name
Ashley Woodcock
Sponsor organisation
Vernalis (R&D) Limited, Steve Pawsey
Eudract number
2009-011525-13
ISRCTN Number
0
Clinicaltrials.gov Identifier
0
Research summary
Any cough lasting more than 2 months is known as a chronic cough. The most common causes are smoking or viral infections but a large proportion of people (12-23 %) who have never smoked cigarettes and who have healthy lungs can also develop a chronic cough. Excessive coughing is a distressing symptom and often causes dizziness, chest pains, incontinence, anxiety and depression. Unfortunately we do not have any effective medications for this type of chronic cough. In chronic cough, the nerves in the lungs may become over-sensitive. We are aiming to develop new medications that return the sensitivity of these nerves back to normal. This study will investigate a drug that has already been shown to reduce the sensitivity of nerves in the skin of healthy volunteers with very few side effects and has been tested in patients with diabetic nerve pain. Twenty non-smoking patients with a chronic cough that has proved difficult to treat will be recruited from our specialist cough clinic in Manchester. All patients will receive the new drug for 8 weeks. They will wear a cough monitor (worn in a bumbag around the waist) for 24 hours at the start of the study, and then after treatment. This will tell us how much they are coughing at the start and end of the study period. They will also fill out a questionnaire. Funding has been obtained from the Medical Research Council for this study.
REC name
North West - Haydock Research Ethics Committee
REC reference
09/H1010/39
Date of REC Opinion
28 Aug 2009
REC opinion
Further Information Favourable Opinion