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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000165987

Acronym

MAID Study

Enrollment

Registered

2011-02-11

Start date

2011-06-01

Completion date

2012-10-08

Last updated

2020-01-13

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

Conditions

None listed

Brief 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.

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 weeks) at week 4.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

35 Years to 75 Years

Healthy volunteers

Inclusion criteria

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 criteria

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

Outcome results