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

NCT03937479 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2020-11-20

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • LGC Limited

    collaborator INDUSTRY

  • Verona Pharma plc

    lead INDUSTRY

Principal Investigators

  • Gary Ferguson · Pulmonary Research Institute of Southeast Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2019-11-15
Completion
2019-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03937479 on ClinicalTrials.gov