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Evaluation of the Effect of Roflumilast in Hyperinflated COPD Patients Using Functional Respiratory Imaging

NCT02451540 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2018-03-21

No results posted yet for this study

Summary

In this study the efficacy of Roflumilast in addition to LAMA/LABA therapy will be assessed using Functional Respiratory Imaging.

In total 40 Chronic obstructive pulmonary disease (COPD) patients, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages C and D, who are stable on LABA/LAMA therapy and who are prone to dynamics hyperinflation will be included in this study. To indicate the susceptibility to dynamics hyperinflation patients should have a baseline Borg Fatigue score after the 6-minute walk test (6MWT) above 4.

The patients will be randomized in such a way that 1 out of 2 patients will receive placebo and 1 the active component.

Image parameters will be assessed and the correlation with lung function and health related quality of life will be checked before and after treatment.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

RADIATION

HRCT scan

HRCT scan of thorax, at baseline and after 3 months

DRUG

Placebo of Roflumilast

Placebo, once a day in the morning during 3 months

DRUG

Roflumilast

Roflumilast, once a day in the morning during 3 months

Sponsors & Collaborators

  • FLUIDDA nv

    lead INDUSTRY

Principal Investigators

  • Wilfried De Backer, M.D., M.S. · University Hospital of Antwerp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

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 NCT02451540 on ClinicalTrials.gov