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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN21056528

Enrollment

Registered

2008-06-09

Start date

2006-08-02

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute lung injury (ALI) Respiratory Injury of other and unspecified intrathoracic organs

Interventions

Subjects will be randomised to the following three arms: Arm 1: Simvastatin 40 mg enterally for 4 days prior to inhalation of LPS Arm 2: Simvastatin 80 mg enterally for 4 days prior to inhalation of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy subjects, both males and females

Exclusion criteria

Exclusion criteria: 1. Age 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

Design outcomes

Primary

Measure	Time frame
Reduction in broncho alveolar lavage (BAL) Interleukin-8 (IL8) concentration at 6 hours	—

Secondary

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

Measure

Time frame

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

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026