• Principal Investigator/s:

Professor Lorcan McGarvey                         

• Name of the Study:

CALM-1 - A Phase 3, 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study with Open-Label Extension of BLU-5937 in Adult Participants with Refractory Chronic Cough, Including Unexplained Chronic Cough

• Why is this Study important?

Chronic cough is a common clinical problem which can persist despite treatment for underlying medical conditions (termed refractory) or for which no identifiable cause is found (unexplained). Currently, in the UK, there are no medicines approved for the treatment of these conditions. It is hoped this study will advance progress in the development of new treatments for chronic cough.

• What is the Research question/aim?

The CALM-1 Study is designed to determine whether a potential new drug (an investigational drug) called BLU-5937 is an effective and safe treatment for people with refractory chronic cough (RCC), including unexplained chronic cough. 

• What the Study involves:

Participation in the study is expected to last about 1.5 years (85 weeks in total).   There will be a total of 19 visits to the study centre during the study.

The study team will also set up 6 phone calls for follow-up during this period.

The study will consist of a 4 week screening period, a 79-week study drug treatment period, and a 2 week follow-up period.

In this study, the investigational study drug, BLU-5937, will be compared against a placebo.

• Who can take part in the Study?

People who have been diagnosed with Refractory Chronic Cough who:

- are between 18 and 80 years of age and

- have had a persistent cough for more than 1 year can take part in this study.

NB: Other criteria must also be met and will be determined by the study doctor.

• Contact Information:

Study Doctor Name: Professor Lorcan McGarvey

Study Doctor Phone: 02895040342

Study Nurse Name: Áine Redfern-Walsh

Study Nurse Phone: 02895040342 / 02896155089

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