Principal Investigator: Professor Lorcan McGarvey

Name of the Study: Eutrema

Why is this Study important?

Based on our data from human samples and animal models, the study treatment is expected to reduce cough and other symptoms, such as wheezing.

What is the Research question/aim?

The investigational medicine will be administered by mouth twice a day. This therapy has been studied in healthy volunteers so far, but this clinical trial has been set-up to evaluate the safety of this therapy in patients with the disease and to help understand if this drug has any potential benefits.

What the Study involves:

Eligible participants will be asked to visit a clinic weekly during the treatment period to ensure their safety and to assess the efficacy of the treatment.

The study medicine will be given orally, twice-a-day for the first two weeks, followed by two weeks of washout period without any study medicine and a second two-week treatment period. During these treatment period, participants will be asked to wear two digital cough recording devices to assess cough symptoms.

At clinic appointments, healthcare professionals will perform physical examinations and carry out a range of tests, including examining bloods, cough stimulation, lung function, and participant well-being using questionnaires to monitor the effects of the study treatment.

Participants will need to attend up to 10 onsite clinic visits with the study clinic. Some appointments may last longer (up to 8 hours) to both dose the investigational medication and ensure participant safety or, to perform assessments to look for benefit. Other visits can be as short as 1 hour

Who can take part in the Study?

This study may be appropriate for you to if:

• You have been diagnosed with chronic refractory cough or unexplained chronic cough for more than 1 year
• You are 18 years of age or older
• You have not smoked for the past 6 month

Contact Information:

Sharon Carr

Senior Research Nurse

University Floor

Belfast City Hospital

BT9 7AB

Sharon.carr@belfasttrust.hscni.net

02895 040345