Evaluation With CT Scan of Possible Changes in Airways After Treatment With Daxas® in Severe Chronic Obstructive Pulmonary Disease Patients

Study Overview
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Brief Summary
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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.

Official Title
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Analysis of Airway Responses in Severe COPD Patients to Daxas®, Using CT Based Functional Respiratory Imaging

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Roflumilast
* Drug: Placebo of Roflumilast
* Radiation: Functional Respiratory Imaging


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Roflumilast<br> | Drug: Roflumilast<br>* Roflumilast 500 µg, once a day in the morning during 6 months<br>* Other names: Daxas®;Radiation: Functional Respiratory Imaging<br>* CT scan of thorax, at baseline and after 6 months<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo of Roflumilast<br>* Placebo 500 µg, once a day in the morning during 6 months<br>Radiation: Functional Respiratory Imaging<br>* CT scan of thorax, at baseline and after 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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®. | At baseline and after 6 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | At baseline and after 6 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Disease, Chronic Obstructive, Computed Tomography scan, Functional Respiratory Imaging, Roflumilast, Health Related Quality of Life