Investigation of the anti-inflammatory effects of simvastatin in a model of acute lung injury after inhalation of lipopolysaccharide by healthy volunteers - Statins in a model of acute lung injury in healthy volunteers
- Conditions
- Acute lung injury (ALI)
- Registration Number
- EUCTR2006-004396-35-GB
- Lead Sponsor
- Belfast City Hospital Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Healthy non-smoking subjects
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
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
• age < 18 years
• creatinine kinase (CK) > 5 times upper limit normal range
• known active liver disease, alcohol abuse or abnormal liver function tests: transaminases > 3 times upper limit normal range
• renal impairment (calculated creatinine clearance less than 60mL/minute)
• known lactose intolerance
• history of asthma
• participation in other trials within 30 days
• pregnancy, breast-feeding or women of childbearing potential not using adequate contraception;
• current treatment with statins
• known hypersensitivity to the study medication
• a previous adverse reaction to statins
• concomitant use of fibrates or other lipid-lowering therapy
• concomitant use of itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone, grapefruit juice, cyclosporine, danazol, amiodarone, verapamil or diltiazem .
• consent declined
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method