TUSSIX Study

Principal Investigator:

Dr Lorcan McGarvey

Name of the Study:

MT1-110 Tussix: A randomised double-blinded, placebo-controlled study of the efficacy, safety and tolerability of serlopitant for the treatment of refractory chronic cough.

Why is this Study important?

This study is investigating the use of a medication called serlopitant in treating refractory chronic cough which is a cough which doesn’t respond to at least 8 weeks of targeted treatment for underlying triggers.

Treatment options are currently very limited. There is no approved drug treatment for this disease.

What is the Research question/ aim?:

The purpose of the study is to compare the potential side effects and effectiveness of serlopitant when taken once a day to placebo (inactive medication) in participants with refractory chronic cough.

What the Study involves:

This is a Phase IIa Study taking place over 126 days (18 weeks) with approximately nine visits to the study clinic and one telephone visit. Participants will receive either serlopitant 5mg or matching placebo. Screening Period:14 days, Treatment Period:84 days, Follow-up Period:28 days.

Person and Patient Involvement (PPI):

There will be no PPI Involvement

Who can take part in the Study?

Eligible patients are those with chronic refractory cough.

Contact Information:

For more information about the Study please contact:

Principal Investigator:

Dr Lorcan McGarvey

Centre for Experimental Medicine

School of Medicine, Dentistry and Biomedical Sciences

Queen's University Belfast

97 Lisburn Road

Belfast

BT9 7BL

Email: l.mcgarvey@qub.ac.uk or lorcan.mcgarvey@belfasttrust.hscni.net

Tel: 028 9097 6377

Clinical Trials’ Practitioner and Research Coordinator:

Sharon Carr

Northern Ireland Clinical Research Facility

U Floor

Belfast City Hospital

Lisburn Road

Belfast

BT9 7AB

Email: sharon.carr@belfasttrust.hscni.net

Tel: 028 950 47647

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