NCT03937479

Study Investigating the Effect of 4 Doses of RPL554 Given in Addition to Tiotropium to Patients With COPD

A Phase II, Randomized, Double-Blind, Placebo Controlled Dose Ranging Study to Assess the Effect of RPL554 Added on to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 416 (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 the dose response of RPL554 in patients with moderate to severe CHRONIC OBSTRUCTIVE PULMONARY DISEASE that are still symptomatic despite treatment with a stable background of tiotropium over 4 weeks of treatment. This study is intended to support optimal dose selection for a Phase III program evaluating RPL554 as an add-on treatment to standard of care therapy.

Detailed description

This is a Phase IIb, randomized, double-blind, placebo controlled, multiple dose, parallel group study to investigate the effects of 4 weeks of treatment with nebulized RPL554 (at different dose levels) compared to placebo in patients with moderate to severe CHRONIC OBSTRUCTIVE PULMONARY DISEASE on a stable background therapy of open-label tiotropium. The study comprises seven visits: Pre-screening (Visit 0), Screening (Visit 1) and then a Treatment Period consisting of Randomization (Visit 2), and weekly visits for 4 weeks (Visit 3 to Visit 6).

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	Ensifentrine (formerly RPL554) 0.375 mg twice daily plus placebo, in addition to tiotropium	Patients will be randomized to receive one of the following treatment arms plus tiotropiuim: ● RPL554 0.375 mg twice daily The approximate planned duration for each completed patient will be 14 days of run-in and 28 days of treatment with study medication.
DRUG	Ensifentrine (formerly RPL554) 0.75 mg twice daily plus placebo, in addition to tiotropium	Patients will be randomized to receive one of the following treatment arms plus tiotropiuim: ● RPL554 0.75 mg twice daily The approximate planned duration for each completed patient will be 14 days of run-in and 28 days of treatment with study medication.
DRUG	Ensifentrine (formerly RPL554) 1.5 mg twice daily plus placebo, in addition to tiotropium	Patients will be randomized to receive one of the following treatment arms plus tiotropiuim: ● RPL554 1.5 mg twice daily The approximate planned duration for each completed patient will be 14 days of run-in and 28 days of treatment with study medication.
DRUG	Ensifentrine (formerly RPL554) 3.0 mg twice daily plus placebo, in addition to tiotropium	Patients will be randomized to receive one of the following treatment arms plus tiotropiuim: ● RPL554 3.0 mg twice daily The approximate planned duration for each completed patient will be 14 days of run-in and 28 days of treatment with study medication.
DRUG	Ensifentrine (formerly RPL554) placebo twice daily, in addition to tiotropium	Patients will be randomized to receive one of the following treatment arms plus tiotropiuim: ● Placebo twice daily The approximate planned duration for each completed patient will be 14 days of run-in and 28 days of treatment with study medication.

Timeline

• Start date: 2019-05-01
• Primary completion: 2019-11-15
• Completion: 2019-11-15
• First posted: 2019-05-03
• Last updated: 2020-11-20
• Results posted: 2020-10-28

Locations

50 sites across 1 country: United States

Regulatory

• FDA-regulated drug study