NCT02542254

The Effects of RPL554 on Top of Standard COPD Reliever Medications

A Phase II, Randomised, Double Blind, Placebo Controlled, Six Way Crossover Study to Assess the Bronchodilator Effect of RPL554 Administered on Top of Salbutamol and Ipratropium in Patients With COPD.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Verona Pharma plc · Industry
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the addition of RPL554 to standard reliever medications for chronic obstructive pulmonary disorder (COPD). All patients will receive the same six treatments in a randomised sequence: 1. salbutamol, 2. ipratropium, 3. salbutamol + RPL554, 4. ipratropium + RPL554, 5. RPL554 6. Placebo

Detailed description

The purpose of this study is to investigate if RPL554 has an additive bronchodilator effect when administered in combination with standard of care bronchodilators in patients with COPD.This study investigates the pharmacodynamic effect of RPL554 using spirometry and whole body plethysmography compared to placebo, when administered in addition to a beta2 agonist (salbutamol), a muscarinic antagonist (ipratropium) or placebo.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	Salbutamol	200 micrograms salbutamol administered using a pressurised metered dose inhaler (pMDI)
DRUG	Ipratropium	40 micrograms ipratropium administered using a pMDI
DRUG	RPL554	6 mg RPL554 administered using a nebuliser
DRUG	Salbutamol matched placebo	Placebo pMDI
DRUG	Ipratropium matched placebo	Placebo pMDI
DRUG	RPL554 matched placebo	Nebulised placebo

Timeline

• Start date: 2015-10-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-09-04
• Last updated: 2016-09-09

Locations

1 site across 1 country: United Kingdom