NCT03028142

The Effects of RPL554 in Addition to Tiotropium in COPD Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Verona Pharma plc · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease Moderate

Interventions

Type	Name	Description
DRUG	1.5 mg RPL554 plus tiotropium
DRUG	6 mg RPL554 plus tiotropium
DRUG	Placebo plus tiotropium

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2017-01-23
• Last updated: 2019-02-27
• Results posted: 2019-01-23