Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Pulmonary Disease, Chronic Obstructive, Computed Tomography scan, Functional Respiratory Imaging, Roflumilast, Health Related Quality of Life
Brief summary
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.
Interventions
DRUGRoflumilast
Roflumilast 500 µg, once a day in the morning during 6 months
Placebo 500 µg, once a day in the morning during 6 months
RADIATIONFunctional Respiratory Imaging
CT scan of thorax, at baseline and after 6 months
Sponsors
FLUIDDA nv
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patient ≥ 30 years old * Patient with BMI ≥ 20 * Written informed consent obtained * Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study. * Patient should be treated according to GOLD guidelines * COPD patient with GOLD stages III until IV * Patient with smoking history of at least 10 pack-years * Patient takes Spiriva® and a fixed combination of inhaled steroids and long acting beta agonist (LABA) at least 6 weeks before visit 1 * Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions.
Exclusion criteria
* Pregnant or lactating females * Patient with severe immunological diseases and/ or severe acute infectious diseases. * Patient with heart failure * Patient with diagnosis of cancer (except basal cell carcinoma) * Patient with a history of depression associated with suicidal ideation or behaviour * Patient with moderate or severe hepatic impairment. * Patient with lactose intolerance * Patient is unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study. * Patient who received any investigational new drug within the last 4 weeks prior to the screening visit or twice the duration of the biological effect of any drug (whichever is longer).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in airway geometry and function using CT based functional respiratory imaging. | At baseline and after 6 months of treatment | 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®. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung function tests (spirometry, bodyplethysmography, diffusion capacity, forced oscillation technique) | At baseline and after 6 months of treatment | Imaging parameters will be assessed and the correlation with lung function will be checked before and after treatment. |
| Health related quality of life | At baseline and after 6 months of treatment | Imaging parameters will be assessed and the correlation with health related quality of life will be checked before and after treatment. |
Countries
Belgium
Outcome results
None listed