The effect of Simvastatin on the immune system of healthy older people

Phase 1

• Conditions: We are investigating the effects of Simvastatin 80mg on neutrophil function (using in vitro studies of neutrophil function), in healthy elderly subjects as there is evidence to suggest that Simvastatin may improve neutrophil responses to inflammation in this population. Clinical and experimental data have suggested that response to infection is improved in patients receiving statins. Our own preliminary in vitro data suggest that this may be due to enhance neutrophil migration.; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-002082-38-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-06
• Study Completion: 2013-09-01
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Inclusion Criteria 1. Age > 60 years 2. Competent to provide informed consent and participate 3. MRC Dyspnoea scale < 2 4. Normal lung function (FEV1 > 80% predicted, FVC > 80% predicted) 5. Normal peripheral oxygenation (as assessed by pulse oximetry, with oxygen saturations above 92%) 6. Free from medications known to alter immune cell function (as outlined in protocol) 7. No clinical evidence of acute infection or chronic illness. 8. Normal liver and kidney function as assessed by peripheral blood liver function tests, urea and creatinine and urinary dipstick.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33

Exclusion Criteria

Exclusion criteria 1. Unable to provide informed written consent 2. History of significant chronic illness including Diabetes, COPD, Asthma, TB, Bronchiectasis, Malignancy, Auto immune disease, Cardiovascular disease. 3. Clinical evidence of acute viral or bacterial infection 4. Any regular medical therapies that may alter immune function 5. Declines to provide permission for GP to be informed 6. Any contraindications for statin therapy (hypersensitivity or abnormal renal or liver function tests)

Study & Design

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