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Bronchodilator Effect of RPL554 Administered in Addition to Tiotropium/Olodaterol in Patients With COPD

NCT03673670 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2019-10-10

Study results available
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Summary

The study investigates the effect of 3 days of twice daily treatment of two different doses of RPL554 (a phosphodiesterase \[PDE\]3/4 inhibitor) or placebo, each administered in addition to once daily tiotropium/olodaterol (Respimat) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Patients will receive each of the three treatment combinations in a randomized sequence using a crossover design

Conditions

Interventions

DRUG

RPL554 Suspension

A PDE3/4 inhibitor

DRUG

Placebo

A placebo solution

DRUG

Tiotropium/olodaterol (Respimat)

An anticholinergic/β-agonist combination medication

Sponsors & Collaborators

  • Verona Pharma plc

    lead INDUSTRY

Principal Investigators

  • Dave Singh · Medicines Evaluation Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2018-07-16
Primary Completion
2018-11-13
Completion
2018-11-13
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT03673670 on ClinicalTrials.gov