CompletedPhase 3ACTRN12611000165987

Microarray analysis following Anti-Inflammatory Interventions in Chronic Obstructive Pulmonary Disease (COPD)

The use of microarray analysis to examine the effects of an anti-inflammatory intervention containing statins, lycopene and fish oil in COPD.


Sponsor

Hunter New England Health Service

Enrollment

15 participants

Start Date

Jun 1, 2011

Study Type

Interventional

Conditions

Summary

This study will use microarray analysis to investigate the effects of statins, antioxidant nutrients and omega-3 fatty acids (fish oil) in COPD. COPD is a condition that involves inflammation of the airways that can cause scarring and airflow limitation of the lung, with the primary cause being cigarette smoking. Statins are drugs which are usually used to lower cholesterol levels but are also known to have anti-inflammatory and possible antioxidant effects. Omega-3 fatty acids and antioxidants have also been found to be useful in reducing inflammation. Hypothesis: Statins, antioxidants and fish oil supplements may have different and potentially complementary effects, on genes involved in inflammatory pathways. The combined use of these interventions may provide a superior approach to reducing inflammation and slowing deterioration of lung function in ex-smokers with obstructive airway disease.


Eligibility

Sex: Both males and femalesMin Age: 35 YearssMax Age: 75 Yearss

Inclusion Criteria1

  • Ex-smokers with a smoking history of a least 10 pack years, obstructive airway disease (FEV1/FVC ratio < 2SD below expected value for age, sex and height)

Exclusion Criteria1

  • Currently taking lipid lowering drugs or drugs that interact with statins, Subjects with active liver disease, renal impairment, cardiovascular disease, pregnant or breast feeding, subjects with known allergies or intolerance to statins or one of the dietary supplements

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Interventions

Oral Simvastatin 40mg (1 tablet daily for 12 weeks) with the addition of oral fish oil (DHA 200mg, EPA 300mg) 1g and oral lycomato (lycopene supplement) 500mg capsules (3 x capsules daily for 8 week

Oral Simvastatin 40mg (1 tablet daily for 12 weeks) with the addition of oral fish oil (DHA 200mg, EPA 300mg) 1g and oral lycomato (lycopene supplement) 500mg capsules (3 x capsules daily for 8 weeks) at week 4.


Locations(1)

John Hunter Hospital - New Lambton

NSW, Australia

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