Simvastatin in Chronic Obstructive Pulmonary Disease (COPD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-02-29

Brief Summary

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To determine the effects of 2 months therapy with simvastatin 40mg once per day compared to placebo in a double-blind placebo-controlled study of patients with COPD.

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Detailed Description

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Statins (HMG-Coenzyme A reductase inhibitors) are widely used clinically as lipid lowering drugs; however they have also been shown to exhibit anti-inflammatory and anti-oxidant properties(1). Recently published large retrospective cohort studies, in patients with chronic obstructive pulmonary disease (COPD), suggest that statins reduce mortality and COPD related admissions(2). Possible mechanisms of action include effects on cell adhesion molecules, changes in inflammatory mediator release, antioxidant effect and increased clearance of apoptoic cells. Simvastatin has been shown to reduce the development of smoking induced emphysema in rats with reductions in MMP-9 activity and simvastatin withdrawal leads to increased MMP levels in hypercholesterolaemic patients. Serum concentrations of TNFa and high sensitive C Reactive protein(3) (hs-CRP) are reduced with simvastatin therapy in patients with hypercholesterolaemia and risk of cardiovascular disease respectively. No clinical trial has directly evaluated the clinical effects of statins in patients with COPD in terms of induced sputum MMP profile, alveolar nitric oxide or pulmonary physiology.

We have modified our published method of RNA purification, developed to purify RNA from cartilage, tendon or synovium(4), to yield good quality RNA from sputum with relative simplicity and low cost. We have identified MMP-2, -9 and -14 in the sputum of healthy volunteers (unpublished pilot data) and will utilise this technique in the current study. Exhaled breath condensate (EBC) is completely non-invasive, requires no co-operation from individuals and provides information about a number of inflammatory and oxidation pathways. Markers of oxidative stress (8-isoprostane and hydrogen peroxide) and nitric oxide products can be measured in exhale breath condensate(5) and are related to disease activity in patients with COPD. Markers of oxidative stress increase in concentration in EBC during exacerbations of COPD are reduced after treatment with the antioxidant N-acetyl cysteine(6). Hydrogen peroxide is not stable and therefore 8-isoprostane is a preferable marker of oxidative stress unless the sample is measured on line.

Conditions

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COPD Emphysema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Simvastatin 40mg

Group Type ACTIVE_COMPARATOR

Simvastatin

Intervention Type DRUG

40mg of Simvastatin once daily

B

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

40mg of placebo once daily

Interventions

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Simvastatin

40mg of Simvastatin once daily

Intervention Type DRUG

Placebo

40mg of placebo once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female, aged more than 45 years.
* Physician labelled diagnosis of chronic obstructive pulmonary disease,emphysema or chronic bronchitis.
* Smoker or ex-smoker with a pack year smoking history of greater than 20 pack years
* FEV1 30-70% predicted
* FEV1/FVC\< 70%
* Body Mass Index \<25kg/m2

Exclusion Criteria

* 1\. Cardiac or pulmonary disease other than chronic obstructive pulmonary disease.
* Untreated hypothyroidism
* Respiratory infection defined as fever, nasal/sinus congestion, fatigue, cough, antibiotic use or yellow/green sputum within 4 weeks prior to study.
* Receiving current oral corticosteroid therapy or leukotriene modifying therapy.
* Severe or uncontrolled co-morbid disease
* History of atopy or asthma
* Clinical history of bronchiectasis
* Pregnancy or breastfeeding
* Women of child-bearing potential, unless adequate contraception is used (ie contraceptive pill or double-barrier contraception - partner using condom and subject using spermicide, diaphragm, intra-uterine device or contraceptive sponge)
* Unable to give written informed consent
* Patients receiving a statin prior to entry into the study
* Hypersensitivity to simvastatin or to any of the excipients.

Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No