Principal Investigator:     Prof. Damian Downey                                             

Name of the Study:         Enterprise
 

Why is this Study important?

Cystic fibrosis (CF) is an inherited disorder that causes sticky mucus to build up in the lungs and digestive system. Current treatments help control the symptoms, but they don’t work for everyone, and some treatments are burdensome. The study drug (called ETD001) works by loosening the mucus in the lungs so it is less sticky making breathing easier and helping to reduce chest infections. This study is the first to give ETD001 to people with CF.

What is the Research question/aim?:  

The study will be run in two parts. Part A will assess if ETD001 is safe to give to people with CF, and Part B will assess if ETD001 improves lung function.

What the Study involves: 

In Part A participants will doses of either ETD001 or placebo. Participants will take up to 56 days to finish the study and make 5 outpatient visits.

In Part B participants will receive ETD001 and doses of placebo. Participants will take up to 133 days to finish the study and will make 8 outpatient visits.

Study assessments include physical examinations, vital signs, heart traces, blood/urine samples, breathing tests and health questionnaires.

Who can take part in the Study? 

Adults over 18 years, with Cystic Fibrosis.

Contact Information:

Michelle Spence, Research Co-ordinator | michelle.spence@belfasttrust.hscni.net  

BHSCT - Respiratory Research Office
Ground Floor, Tower Block
Belfast City Hospital
51 Lisburn Road
BT9 7AB
02895041953