E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
chronic obstructive pulmonary disease |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010952 |
E.1.2 | Term | COPD |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the effects of ROFLUMILAST 500µg once daily on arterial stiffness in patients with COPD |
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E.2.2 | Secondary objectives of the trial |
To investigate the effects of ROFLUMILAST 500µg once daily on endothelial dysfunction in patients with COPD |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Over 40 years of age Smoking history of at least 10 pack years Chronic obstructive pulmonary disease at GOLD-stage II - IV History of at least one COPD exacerbation requiring systemic corticosteroid treatment or hospitalisation in the previous year
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E.4 | Principal exclusion criteria |
Insufficient compliance to study medication (≤70% of tablets used) during 4 weeks run-in period History of acute exacerbation 4 weeks prior to run-in period Diagnosis of alpha-1-antitrypsine deficiency Diagnosis of asthma Acute respiratory infections (e.g. pneumonia) Severe acute infectious diseases (e.g. active hepatitis, HIV) Lung cancer Bronchiectasis Interstitial lung disease Any other relevant lung disease Acute myocardial infarction Systolic left ventricular dysfunction Congestive heart failure NYHA (New York Heart Association Functional Classification) severity grade IV) Haemodynamically significant cardiac arrhythmias or heart valve deformations Peripheral arterial occlusive disease Acute or chronic renal/hepatic failure Active malignancy Autoimmune disease Pregnant or breastfeeding women Women no using or not willing to use adequate contraceptive measures for the duration of the trial Hypersensitivity to study medication or placebo Severe psychiatric or neurological disorders or history of depression associated with suicidal ideation or behaviour Galactose intolerance, lactase insufficiency or glucose-galactose malabsorption
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E.5 End points |
E.5.1 | Primary end point(s) |
Between groups difference after 24 weeks in the change of carotid femoral-Pulse Wave Velocity |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
24 weeks ofter start of study drug administration |
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E.5.2 | Secondary end point(s) |
between groups difference after 24 weeks in the change of: - Augmentation Index - Reactive Hyperemia Index - C-reactive Protein - Matrix Metalloproteinase-9 - Asymmetric dimethylarginine - soluble Receptor for Advanced Glycation Endproducts - Brachial artery Intima-Media Thickness - Forced Expiratory Volume in one sekond - 6 Minute Walk Test - St. George Respiratory Questionaire - COPD assessment test (CAT score)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
24 weeks ofter start of study drug administration |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |