Principal Investigator: Lorcan McGarvey
Name of the Study: A Randomised, Double-blind, Placebo-controlled, Crossover, Dose Escalation Study of BLU-5937 in Subjects with Unexplained or Refractory Chronic Cough [RELIEF]
Short name: RELIEF BUS-P2-01
Why is this important?
The prevalence of chronic cough has been estimated as affecting 11-13% of the population and there have been no FDA approvals for a novel pharmaceutical agent to treat cough in over 50 years. Chronic cough can seriously impair quality of life as it has physical (exhaustion, sleep deprivation, urinary incontinence, vomiting, headache, rib fracture) social (interference with lifestyle and leisure, embarrassment of coughing in public, social exclusion) and psychosocial (depression, frustration, anxiety) consequences.
What is the Research question/aim?
A clinical drug trial is investigating drug BLU-5937. This drug is being tested for the treatment of unexplained refractory chronic cough. The purpose of the study is to compare the potential side effects and effectiveness of BLU-5937 taken twice daily to a placebo.
What the Study involves:
The study will include approx. 51 participants at centres across the UK and USA. The study involves participants attending 14 visits taking place over approx. 74 days. Eight of those visits can be conducted at the participant’s home if so wished. Each visit will last approx. 2-3 hours. Participants will also be asked to wear a cough monitor for 24 hours multiple times during the trial to monitor any changes.
Who can take part in the Study?
The study will enroll women and men aged 18-80 years old who have unexplained, refractory chronic cough for at least one year. Participant’s medical history, medication use, contraception use and smoking status will need to be reviewed to confirm if they are eligible to take part.
Lorcan McGarvey Principal Investigator
Contact phone number: 02895041136
Danielle Dawson, Research Nurse
Contact phone number: 02895048253
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