Does simvastatin treatment affect COPD exacerbations? - Evaluation in a randomized controlled trial

Phase 1

• Conditions: patients with COPD in stage II-IV (according to the GOLD classification); MedDRA version: 14.1Level: LLTClassification code 10029978Term: Obstructive chronic bronchitis with acute exacerbationSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]; MedDRA version: 14.1Level: PTClassification code 10009033Term: Chronic obstructive pulmonary diseaseSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

• Registration Number: EUCTR2011-004166-16-AT
• Lead Sponsor: Abteilung für Pulmologie, Landesklinikum Thermenregion Hochegg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-09
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 208

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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)