AF219-010 Dose Escalation in Subjects with Refractory Chronic Cough
Research type
Research Study
Full title
A Dose Escalation Study to Assess the Efficacy and Tolerance of AF 219 in Subjects with Refractory Chronic Cough
IRAS ID
174489
Contact name
Jacky Smith
Contact email
Sponsor organisation
Afferent Pharmacuticals
Eudract number
2015-000474-35
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 4 days
Research summary
There is currently no treatment available for patients with Refractory Chronic Cough. This study will evaluate the dose response and identify tolerable dose(s) that reduce daytime objective cough frequency in these patients. This will be measured using questionnaires and a cough monitor (recording device).
This is a randomised (meaning that each individual will receive the intervention but in a random order) double blind (treatment allocation is not known to patient, investigator, site staff and Sponsor), cross over (subjects will receive either, have a “wash out” phase, (no study drug), then placebo (a substance that has no therapeutic effect, used as a control in testing new drugs). Alternatively subjects will receive the placebo drug first then “wash out” and then study drug). This is a phase II study of the drug AF-219 in patients with refractory chronic cough. Approximately 30 subjects will be consented and randomised into the study, following the screening process. They will be involved in the study for up to 10 weeks in total.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
15/NE/0148
Date of REC Opinion
7 Jul 2015
REC opinion
Further Information Favourable Opinion