Investigation of the anti-inflammatory effects of simvastatin in a human lipopolysaccharide induced model of acute lung injury

Completed

• Conditions: Acute lung injury (ALI); Respiratory; Injury of other and unspecified intrathoracic organs

• Registration Number: ISRCTN21056528
• Lead Sponsor: Belfast Health and Social Care Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-09
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Healthy subjects, both males and females

Exclusion Criteria

1. Age <18 years
2. Creatinine kinase (CK) >5 times upper limit of normal
3. Known active liver disease
4. Alcohol abuse or abnormal liver function tests: transaminases > 3 times upper limit of normal
5. Renal impairment (calculated creatinine clearance less than 60 mL/minute)
6. History of asthma, known lactose intolerance
7. Participation in other trials within the past 30 days
8. Pregnancy, breast-feeding or women of childbearing potential not using adequate contraception;
9. Current treatment with statins
10. Known hypersensitivity to the study medication
11. Previous adverse reaction to statins
12. Concomitant use of fibrates or other lipid-lowering therapy
13. Concomitant use of itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, grapefruit juice, cyclosporine, danazol, amiodarone, verapamil or diltiazem
14. Consent declined

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in broncho alveolar lavage (BAL) Interleukin-8 (IL8) concentration at 6 hours

Secondary Outcome Measures

Name	Time	Method
1. To investigate whether treatment with simvastatin will modulate the following: <br>1.1. Alveolar inflammatory response at 6 hours<br>1.2 Plasma inflammatory response at 24 hours<br>1.3. Alveolar matrix metalloproteinase activity at 6 hours<br>1.4. Intracellular signalling in the alveolar space at 6 hours<br>1.5. Indices of alveolar epithelial and endothelial function and injury at 6 hours<br>2. To determine the potential mechanisms by which simvastatin may be beneficial in ALI