* RPL554-CO-301
Research type
Research Study
Full title
A Phase III Randomized, Double-Blind, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Ensifentrine over 24 Weeks (With a 48-Week Safety Subset) in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease.
IRAS ID
302969
Contact name
Brian Leaker
Contact email
Sponsor organisation
Verona Pharma
Eudract number
2020-002086-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
This is a multicenter, randomised, double blind, parallel group, placebo controlled study to evaluate the efficacy and safety of ensifentrine 3 mg vs placebo administered twice daily over 24 weeks (with a 48-week safety subset), via nebuliser in patients 40 to 80 years of age with moderate to severe COPD.
Enisfentrine is an inhaled selective dual phosphodiesterase (PDE)3 and PDE4 inhibitor being developed for maintenance treatment of chronic obstructive pulmonary disease (COPD).In previous clinical studies,Ensifentrine has demonstrated bronchodilation(this is when breathing airways that would have been closed up begin to open up) and anti-inflammatory (stops inflammation) activity following inhaled dosing. Furthermore, ensifentrine has been well tolerated in the clinical studies conducted to date with a safety profile similar to placebo. As a potential new treatment for COPD, this important mechanism of action can be used as a monotherapy or added to current inhaled standard of care bronchodilator and anti-inflammatory therapies. Ensifentrine is first being developed as an inhaled suspension formulation for delivery via a nebulizer for patients with COPD.
The purpose of the study is to determine if the study drug ensifentrine (3 mg) works when given twice a day for 24 or 48 weeks in patients with moderate to severe COPD. The study will also look at the safety and tolerability of the study drug in this patient group.Eligible participants will be invited to participate over 24 weeks or 48 weeks consisting of a screening, treatment, and follow-up (via telephone) phase.REC name
London - Dulwich Research Ethics Committee
REC reference
21/FT/0096
Date of REC Opinion
10 Aug 2021
REC opinion
Further Information Favourable Opinion