E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with COPD in stage II-IV (according to the GOLD classification) |
COPD Patienten im GOLD Stadium II-IV |
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E.1.1.1 | Medical condition in easily understood language |
Chronic obstructive pulmonary disease (COPD) is a disease of the lungs in which the airways become narrowed. |
Patienten mit mittelschwerer (GOLD Stadium II) bis sehr schwerer (GOLD Stadium IV) chronisch obstruktiver Lungenerkrankung |
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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 | PT |
E.1.2 | Classification code | 10009033 |
E.1.2 | Term | Chronic obstructive pulmonary disease |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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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 | 10029978 |
E.1.2 | Term | Obstructive chronic bronchitis with acute exacerbation |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 |
The main study objective is the find out if a 1-year statin-treatment (40mg simvastatin per day) reduces the time to COPD exacerbation (use of oral steroids und/or antibiotics und/or inpatient admission) in patients with moderate (stage II) to very severe (stage IV) COPD as compared to placebo. |
Das Ziel der vorliegenden Studie ist es herauszufinden, ob eine 1-jährige Statin-Therapie die Zeit bis zur ersten COPD Exazerbationen (Einnahme von oralen Steroiden und/oder Antibiotika und/oder Hospitalisierung aufgrund der Symptomatik) im Vergleich zu Placebo signifikant reduzieren kann. |
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E.2.2 | Secondary objectives of the trial |
The secondary study objective is the find out if a 1-year statin-treatment (40mg simvastatin per day) reduces the frequency of severe (use of oral steroids and/or antibiotics and inpatient admission) moderate COPD exacerbations (use of oral steroids and/or antibiotics; no inpatient admission) in patients with moderate (stage II) to very severe (stage IV) COPD. |
Anzahl der schweren (Einnahme von oralen Steroiden und/oder Antibiotika und Hospitalisierung aufgrund der Symptomatik) und „moderaten“ COPD Exazerbationen (Einnahme von oralen Steroiden und/oder Antibiotika aufgrund der Symptomatik; keine Hospitalisierung) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• male or postmenopausal (amenorrhoe > 12 month) female patients with an age of 40 to 85 years • diagnosed COPD im stage II-IV according to GOLD • smoker or prior smoker with at least 20 pack years |
• Männlich oder weibliche postmenopausale (Amenorrhoe von mindestens 12 Monaten) Patienten mit einem Alter zwischen 40 und 85 Jahren • Diagnostizierte COPD im Stadium II-IV nach GOLD • Raucher oder Ex-Raucher mit zumindest 20 „Packungsjahren“
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E.4 | Principal exclusion criteria |
• diagnosed lung diseases except from COPD, bronchiectasis and chronic asthmatic bronchitis • known vascular diseases like instable angina pectoris, prior myocardial infarction, stroke or peripheral artery disease • known heart valve disease, relevant arrhythmia, conduction disorder or cardiac insufficiancy • severe hypertension despite medical treatment • treatment with CYP3A4 inhibitors (e.g. itraconazol, ketoconazol, HIV- protease inhiitors, erythromycin, clarithromycin, telithromycin and nefazodon) • severe liver disorder • chronic kidney disease (kreatinin-clearance < 30ml/min) • allergy to simvastatin • known myopathy or other diseases with an increased risk of rhabdomyolysis • galaktose intolerance, Lapp lactase deficiency or glucose galactose malabsorption • statin therapy within the last 4 weeks pror to study enrollment • disability to give written consent |
• Andere diagnostizierte Lungenerkrankung abgesehen von COPD, außer chronisch asthmatische Bronchitis und Bronchiektasien • Anamnestisch bekannte koronare Herzerkrankung, wie instabile Angina pectoris, früherer Myokardinfarkt; cerebrovaskuläre Insuffizienz, wie Z.n. Zerebralinsult oder periphere arterielle Verschlusskrankheit • Klinisch signifikante Herzklappenerkrankung, signifikante Arrhythmien oder Überleitungsstörungen, Links- oder Rechtsherzinsuffizienz • Unkontrollierte arterielle Hypertonie • Gleichzeitige Verabreichung von hochwirksamen CYP3A4-Hemmern (z.B. Itraconazol, Ketoconazol, HIV-Proteasehemmern, Erythromycin, Clarithromycin, Telithromycin und Nefazodon) • aktive Lebererkrankung, einschließlich einer ungeklärten andauernden Erhöhung der Serum-Transaminasen sowie jeglicher Erhöhung der Serum-Transaminasekonzentration auf mehr als das Dreifache des oberen Normalwertes • Chronische Niereninsuffizienz (Kreatinin Clearance < 30ml/min) • Bekannte Überempfindlichkeit gegenüber Simvastatin, Substanzen mit ähnlicher chemischer Struktur oder einen Arzneimittelträger • Bekannte Myopathie bzw. Erkrankungen mit einem erhöhtem Risiko für eine Rhabdomyolyse • Galaktoseintoleranz, Lapp-Laktase-Defizit oder Glukose-Galaktose-Malabsorption • Statin-Therapie innerhalb der letzten 4 Wochen vor Studieneinschluss • Unfähigkeit eine schriftliche Einverständniserklärung zu geben
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E.5 End points |
E.5.1 | Primary end point(s) |
the time to first COPD exacerbations (use of oral steroids und/or antibiotics and/or inpatient admission) in patients with moderate (stage II) to very severe (stage IV) COPD. |
Zeit bis zur ersten COPD Exazerbation (Einnahme von oralen Steroiden und/oder Antibiotika und/oder Hospitalisierung aufgrund der Symptomatik) innerhalb des Studienjahres |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1 year (365 days) |
1 Jahr (365 Tage) |
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E.5.2 | Secondary end point(s) |
the frequency of severe (use of oral steroids and/or antibiotics and inpatient admission) and moderate COPD exacerbations (use of oral steroids und/or antibiotics; no inpatient admission) in patients with moderate (stage II) to very severe (stage IV) COPD. |
Anzahl der schweren (Einnahme von oralen Steroiden und/oder Antibiotika und Hospitalisierung aufgrund der Symptomatik) und „moderaten“ COPD Exazerbationen (Einnahme von oralen Steroiden und/oder Antibiotika aufgrund der Symptomatik; keine Hospitalisierung) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 year (365 days) |
1 Jahr (365 Tage) |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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.8.6 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 | 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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |