Study of Ensifentrine in NCFBE
Research type
Research Study
Full title
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Ensifentrine in Subjects with Non-Cystic Fibrosis Bronchiectasis
IRAS ID
1010760
Contact name
Caroline Diaz
Contact email
Sponsor organisation
Verona Pharma plc
Clinicaltrials.gov Identifier
Research summary
This study is testing an investigational drug called Ensifentrine in adult patients with Non-Cystic Fibrosis Bronchiectasis. Ensifentrine can relax the muscles in the lungs and widen the airways, making breathing easier. It also has anti-inflammatory effects. The study will recruit 180 participants across the UK, Italy, Spain and the USA. Participants will be divided into two groups, Ensifentrine or placebo, and neither the participant nor the study doctors will know what treatment has been assigned. The placebo has no active ingredients and will be used to help doctors see if effects are due to Ensifentrine or not. The treatment will be assigned by a computer at random. Participants will continue taking their regular medication while participating in the study.
The study drug will be administered via inhalation, using a small machine that turns liquid medicine into a mist that can be inhaled. The purpose of the study is to look at whether taking Ensifentrine reduces flares of Non-Cystic Fibrosis Bronchiectasis, its effect on symptoms, quality of life, and how safe it is compared to placebo.
Participants will be in the study for between 24 weeks and up to 3 years, and the study will end when either the last participant recruited completes their Week 24 visit, or when 120 participants experience 1 or more deteriorations in lung infections (called a pulmonary exacerbation).
During the study, participants visit the study site every 6 weeks until Week 24, and then every 8 weeks until the study is completed. As part of the study, participants will undergo physical examinations, demographics and medical history assessments, electrocardiograms, blood tests, and will have to complete questionnaires in an e-diary which will be provided to them.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
24/YH/0265
Date of REC Opinion
30 Dec 2024
REC opinion
Further Information Favourable Opinion