E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Evaluar en la EPOC estable el efecto de la simvastatina sobre: (1) la función endotelial; (2) la inflamación pulmonar y sistémica; y, (3) el índice BODE (B: masa corporal, O: obstrucción bronquial, D: disnea y, E: tolerancia al ejercicio). (To investigate the efficacy of simvastatin in patients with COPD on: (1) pulmonary and systemic inflammation; (2) endothelial function; and, (3) BODE (B: body mass index, O: bronchial obstruction, D: dyspnea and, E: exercise tolerance) index). |
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MedDRA Classification |
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 study in patients with stable COPD the efficacy of statins (simvastatin) on endothelial function evaluated by vascular reactivity and number of circulating endothelial progenitor cells. |
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E.2.2 | Secondary objectives of the trial |
To evaluate in patients with stable COPD the efficacy of statins on: (1) pulmonary and systemic inflammation; and (2) BODE (B: body mass index, O: bronchial obstruction, D: dyspnea and, E: exercise tolerance) index. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male former smokers with moderate to severe (FEV1 between 30 and 80% predicted post-bronchodilation) stable COPD (GOLD II-III) with 40-80 years of age. |
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E.4 | Principal exclusion criteria |
To be diagnosed of chronic diseases different to chronic obstructive pulmonary disease (COPD) (neoplasm, chronic pain, liver diseases, kidney diseases, bronchial asthma, hypertension, any acute or chronic vascular disease, diabetes, or diabetes, etc), regular use of some medications (statins, vasodilators, hypnotics...), any drug abuse including alcoholism, oral or parenteral corticosteroids and non-steroidal anti-inflammatory drugs during the lasts 4 weeks or to increase FEV1 more than 200 mL and 12% after the administration of inhaled bronchodilators). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Biological variables: (1) markers of endothelial function: circulating endothelial progenitor cells, expression of soluble adhesion molecules and assessment of systemic vascular reactivity; (2) pulmonary inflammation: exhaled nitric oxide, cytokines (IL) 1, 6, 8, antioxidant capacity and oxidative stress in sputum; (3) systemic inflammation: C reactive protein (CRP), antioxidant capacity and oxidative stress, IL- 1, 6, 8 in plasma. |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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.8.3 |
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.8.5 | The trial involves multiple Member States | No |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |