NCT04091360

A Study of RPL554 Drug Administered by Metered Dose Inhaler to Treat Chronic Obstructive Pulmonary Disease

A Phase II, Randomised Study to Assess the Pharmacokinetics, Safety and Pharmacodynamics of Single and Repeat Doses of RPL554 Administered by Pressurised Metered Dose Inhaler in Patients With COPD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Verona Pharma plc · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate 5 doses of RPL554 and placebo, administered by pressurized metered dose inhaler (pMDI), in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Detailed description

The study will consist of two parts. Part A is a parallel group, placebo-controlled single dose study to ascertain the Pharmacokinetics (PK) profile, safety and bronchodilator effect of a single dose of RPL554 administered via pMDI. Five of the 6 treatment arms will be double-blind and one will be single-blind (due to the different number of capsules administered). Part B is a 7-day placebo-controlled, complete block cross-over, repeat dose study to assess the bronchodilator effect of repeat doses of RPL554 delivered via pMDI.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	Part A: RPL554	Single dose RPL554 via metered dose inhaler.
DRUG	Placebos	Part A: Single dose placebo via metered dose inhaler. Part B: Repeat doses of placebo via metered dose inhaler in crossover fashion. One dose administered twice daily over 7 days.
DRUG	Part B: RPL554	Part B: Repeat doses via metered dose inhaler in crossover fashion. One dose administered twice daily over 7 days.

Timeline

• Start date: 2019-04-29
• Primary completion: 2020-12-10
• Completion: 2021-01-21
• First posted: 2019-09-16
• Last updated: 2022-09-21
• Results posted: 2022-07-25

Locations

2 sites across 1 country: United Kingdom