The effects of RPL554 in addition to tiotropium in COPD patients
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 in patients with COPD.
IRAS ID
218240
Contact name
Paula Siu
Contact email
Sponsor organisation
Verona Pharma plc
Eudract number
2016-004450-15
Duration of Study in the UK
0 years, 3 months, 9 days
Research summary
This is a phase II, randomised, double blind, placebo controlled, complete block, three way crossover study to investigate treatment with nebulised RPL554 and tiotropium together in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
The purpose of this study is to assess the bronchodilator effect (opening of the airways) of RPL554 when used in combination with a long acting anti-muscarinic receptor antagonist (tiotropium) whilst dosing the RPL554 to steady state blood levels.
It is planned to randomise up to 30 patients to have 24 evaluable patients at one study centre. In each treatment period, patients will receive an open label dose of tiotropium from a dry power inhaler (DPI) followed immediately by a double blind dose of either RPL554 6mg, 1.5mg or placebo (depending on treatment sequence) from a nebuliser in the morning on Day 1, Day 2 and Day 3. The dose of RPL554 or placebo will be repeated in the evening on Day 1 and Day 2; there will not be an evening dose on Day 3.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
16/NW/0876
Date of REC Opinion
27 Jan 2017
REC opinion
Further Information Favourable Opinion