In this study the possible changes in airway geometry and function induced by 6 month oral treatment with Daxas® (roflumilast) will be evaluated. The use of functional respiratory imaging (FRI) on the phenotyping of chronic obstructive pulmonary disease (COPD) patients will be examined. The study population consists of 40 severe COPD patients, global initiative for chronic obstructive lung disease (GOLD) stages III until IV. Imaging parameters will be assessed and the correlation with lung function and health related quality of life will be checked before and after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
TRIPLE
Enrollment
41
Roflumilast 500 µg, once a day in the morning during 6 months
Placebo 500 µg, once a day in the morning during 6 months
CT scan of thorax, at baseline and after 6 months
ZNA Middelheim
Antwerp, Antwerp, Belgium
Antwerp University Hospital
Edegem, Antwerp, Belgium
Changes in airway geometry and function using CT based functional respiratory imaging.
The primary objective of this study is to evaluate the possible use of CT based functional respiratory imaging (CT-FRI) on the phenotyping of severe COPD patients after a 6 month treatment with Daxas®.
Time frame: At baseline and after 6 months of treatment
Lung function tests (spirometry, bodyplethysmography, diffusion capacity, forced oscillation technique)
Imaging parameters will be assessed and the correlation with lung function will be checked before and after treatment.
Time frame: At baseline and after 6 months of treatment
Health related quality of life
Imaging parameters will be assessed and the correlation with health related quality of life will be checked before and after treatment.
Time frame: At baseline and after 6 months of treatment
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