patients with COPD in stage II-IV (according to the GOLD classification) MedDRA version: 14.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level: LLT Classification code 10029978 Term: Obstructive chronic bronchitis with acute exacerbation System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Simvastatin 40mg-Filmtabletten
Pharmaceutical Form: Tablet
CAS Number: 79902-63-9
Other descriptive name: SIMVASTATIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
Abteilung für Pulmologie, Landesklinikum Thermenregion Hochegg
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 104 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 104
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;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.;Timepoint(s) of evaluation of this end point: 1 year (365 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;Timepoint(s) of evaluation of this end point: 1 year (365 days) | — |
Countries
Austria
Contacts
Public ContactPrim. Peter Schenk
Abteilung für Pulmologie, Landesklinikum Thermenregion Hochegg
Outcome results
None listed