NCT02427165

Comparison of RPL554 With Placebo and Salbutamol in Asthmatic Patients

A Phase II, Randomised, Double Blind, Placebo Controlled, Seven Way Crossover Study to Assess the Effect of Single Doses of RPL554 Compared to Salbutamol and Placebo Administered by Nebuliser on Lung Function of Patients With Chronic Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Verona Pharma plc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The number of people with of asthma and allergy is still increasing and a large number of patients still do not have their asthma well controlled. There is therefore a need for new asthma treatments that work well and have less side effects. The study compares a new experimental drug RPL554 with a marketed asthma drug (salbutamol) and placebo.

Detailed description

A seven way crossover study to investigate the pharmacodynamics, pharmacokinetics, safety and tolerability of inhaled RPL554 compared to salbutamol and placebo in patients with mild to moderate chronic asthma. Salbutamol is a marketed beta-2 agonist typically used to treat bronchospasm (due to any cause, allergen asthma or exercise-induced), as well as chronic obstructive pulmonary disease but has associated dose-related systemic side effects. RPL554 is a dual PDE3 and PDE4 inhibitor that has bronchodilatory and anti-inflammatory actions and also the potential to stimulate increases in mucociliary clearance via its proven ability to activate CFTR. Four different doses of RPL554 will be compared with placebo and a two doses of salbutamol as benchmarks for bronchodilation and systemic side effects.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	RPL554	A dual PDE3 and PDE4 inhibitor
DRUG	Salbutamol	a beta-2 receptor agonist
DRUG	Placebo	RPL554 placebo containing no active ingredients

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2015-04-27
• Last updated: 2016-09-09

Locations

2 sites across 2 countries: Sweden, United Kingdom