VERONA RPL554-CO-204: RPL554 + tiotropium/olodaterol in COPD
Research type
Research Study
Full title
A PHASE II, RANDOMISED, DOUBLE BLIND, PLACEBO CONTROLLED, THREE WAY CROSSOVER STUDY TO ASSESS THE BRONCHODILATOR EFFECT OF RPL554 ADMINISTERED IN ADDITION TO OPEN LABEL TIOTROPIUM/OLODATEROL IN PATIENTS WITH COPD
IRAS ID
248466
Contact name
Brian Leaker
Contact email
Sponsor organisation
Verona Pharma PLC
Eudract number
2018-001037-41
Duration of Study in the UK
0 years, 4 months, 27 days
Research summary
The purpose of this study is to see how well a new drug called RPL554 works when administered with two other approved drugs (tiotropium/olodaterol) for Chronic Obstructive Pulmonary Disease (COPD), a type of lung disease. It will also evaluate how safe the drug is and how the body processes it (called pharmacokinetics). RPL554 is a new inhaled drug being developed for the treatment of COPD and has not yet been approved for use. RPL554 appears to decrease inflammation in the lung (thought to play a role in COPD), and helps to open up lung airways (called “bronchodilation”), making it easier to breathe.
Approximately 70 patients will be enrolled at up to 4 centres in the USA and UK. Participants will undergo three treatment periods during the study, during each of which they will receive one of three different treatment combinations as follows: 1) RPL554 1.5 milligrams (mg) twice per day, 2) RPL554 6 mg twice per day and 3) placebo twice per day. Participants will also receive tiotropium/olodaterol (5 micrograms [mcg] of each) once per day. A placebo looks the same as the study drug, but contains no actual medication.
Each participant will be in the study for up to 61 days (about 2 months) and attend approximately 6 visits:
• Screening visit – Day 1 (7 to 14 days before the first treatment visit), including placement of a Holter monitor, a device used to measure heart function
• Screening visit – Day 2 (to remove the Holter monitor)
• Three treatment visits, each lasting 3 days with 7 to 14 days between treatment periods
• During the study, each study participant will receive 6 doses each of RPL554 1.5 mg and 6 mg, 6 doses of placebo and 9 doses of the tiotropium/olodaterol combination
• Follow-up visit (4 to 10 days after last treatment visit)REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
18/EM/0231
Date of REC Opinion
4 Sep 2018
REC opinion
Further Information Favourable Opinion