Investigation of the anti-inflammatory effects of simvastatin in a human lipopolysaccharide induced model of acute lung injury
| ISRCTN | ISRCTN21056528 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21056528 |
| Protocol serial number | 060778SE-A |
| Sponsor | Belfast Health and Social Care Trust (UK) |
| Funders | Intensive Care Society, Young Investigator's Award (UK), REVIVE (UK), Northern Ireland Health and Social Services Central Services Agency (UK) |
- Submission date
- 29/04/2008
- Registration date
- 09/06/2008
- Last edited
- 30/06/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Danny McAuley
Scientific
Scientific
Intensive Care Unit
Royal Victoria Hospital
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, randomised, double-blind, placebo-controlled trial. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Treatment with a clinically relevant dose of simvastatin will reduce pulmonary inflammation induced by lipopolysaccharide (LPS) inhalation in humans. |
| Ethics approval(s) | Office for Research Ethics Committees Northern Ireland (ORECNI). Date of approval: 25/10/2006 (ref: 06/NIR02/91) |
| Health condition(s) or problem(s) studied | Acute lung injury (ALI) |
| Intervention | 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 LPS Arm 3: Placebo enterally for 4 days prior to inhalation of LPS |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | simvastatin |
| Primary outcome measure(s) |
Reduction in broncho alveolar lavage (BAL) Interleukin-8 (IL8) concentration at 6 hours |
| Key secondary outcome measure(s) |
1. To investigate whether treatment with simvastatin will modulate the following: |
| Completion date | 05/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | Healthy subjects, both males and females |
| Key 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 |
| Date of first enrolment | 02/08/2006 |
| Date of final enrolment | 05/11/2009 |
Locations
Countries of recruitment
- United Kingdom
- Northern Ireland
Study participating centre
Intensive Care Unit
Belfast
BT12 6BA
United Kingdom
BT12 6BA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/06/2009 | Yes | No |
