Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Placebo Controlled Study to Assess the Effect of Roflumilast in Hyperinflated COPD Patients in Addition to LABA/LAMA Therapy Using Functional Respiratory Imaging.
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.
n/a
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