Evaluation of the Effect of Roflumilast in Hyperinflated COPD Patients Using Functional Respiratory Imaging
Status:
Terminated
Trial end date:
2017-08-31
Target enrollment:
Participant gender:
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.