Study RPL554-CO-203. RPL554 in Patients with Moderate to Severe COPD
Research type
Research Study
Full title
A Phase IIb, randomized, double blind, placebo controlled dose ranging study to assess the effect of RPL554 in patients with moderate to severe COPD.
IRAS ID
226616
Contact name
Louisa Vass
Contact email
Sponsor organisation
Verona Pharma plc
Eudract number
2016-005205-40
Duration of Study in the UK
0 years, 7 months, 11 days
Research summary
The purpose of this clinical research study is to investigate the effects of a new drug called RPL554 when administered at different doses and compared to placebo in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) – a type of lung disease. RPL554 is a new inhaled drug that is being developed for the treatment of COPD. RPL554 appears to slow down inflammation (which is thought to play a role in COPD), and helps to open up lung airways (called “bronchodilation”), making it easier to breathe. RPL554 is an investigational product, which means that it has not been approved for use in any country yet. \n\nThis is a Phase II study, which means that the drug has already been taken by other people in clinical research studies. Over 240 people have been given RPL554 in clinical studies so far. This study will involve giving the study drug to a larger number of patients with COPD to learn more about how effective and safe the drug is.\n\nIt is planned to enrol approximately 400 patients at approximately 45 centres in the USA and EU. \n\nParticipants will receive either one of four different doses (0.75mg, 1.5 mg, 3.0 mg or 6.0 mg) of RPL554 or placebo (inactive dummy) twice daily for four weeks. \n\nThe study will comprise of approximately 9 visits: Informed consent (Consent Visit), screening (Visit 1), randomisation (Visit 2), 4 weekly visits (Visit 3 – Visit 6). There are also two additional short visits (Visits 1b and 6a) of about 30 minutes in duration to remove and place a Holter Monitor for heart monitoring. The study duration will be approximately 42 days: 7-14 days of screening followed by 28 days (4 weeks) of treatment. There will be a follow-up phone call 14 days after the final study visit (Visit 6).
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
17/NW/0376
Date of REC Opinion
7 Aug 2017
REC opinion
Further Information Favourable Opinion