The Effect of Statins in Patients With 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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-08-31

Brief Summary

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Chronic obstructive pulmonary disease (COPD) is a condition of the lungs which results in breathing difficulties due to the lungs becoming inflamed and the airways narrowed. Current treatments have focused on opening up the narrowed airways but, in addition, we know there is increased inflammation in the blood and these patients are at increased risk of heart disease. Statins, simvastatin being one of them, are drugs used to lower cholesterol in the blood but may also reduce inflammation and lower the risk of heart disease. This study will explore whether simvastatin reduces one of the risk factors in patients with COPD in a short term proof of principle study. The key purpose is to determine whether simvastatin improves the pressure and stiffness of the main blood vessels namely the arterial stiffness measure of aortic pulse wave velocity (PWV). In parallel, we will describe changes in airways and / or blood inflammation and change in breathing ability

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lactose tablet

Group Type PLACEBO_COMPARATOR

Lactose tablet

Intervention Type DRUG

One tablet taken each evening for 6 weeks

Simvastatin 20mg

Group Type ACTIVE_COMPARATOR

Simvastatin

Intervention Type DRUG

Simvastatin 20mg once daily (in the evening) for 6 weeks

Interventions

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Simvastatin

Simvastatin 20mg once daily (in the evening) for 6 weeks

Intervention Type DRUG

Lactose tablet

One tablet taken each evening for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female patients aged 45-80 years;
* Confirmed COPD: FEV1 30-80% predicted, FEV1/FVC\<0.7, salbutamol reversibility \<12%, supportive smoking history
* If female of childbearing potential, have a negative serum pregnancy test at screening and use a medically acceptable form of contraception starting at screening and continuing throughout the study (defined as an oral contraceptive, or barrier method combined with a spermicide)
* Able to attend for regular clinic appointments
* In opinion of investigator, the patient will be able to comply with the requirements of the protocol
* Provide written informed consent.

Exclusion Criteria

* Known hypersensitivity to or side effects relating to previous statin treatment, or current therapy which includes a statin, ezetimibe or fibrate
* Clinically significant liver function abnormality; alcohol excess
* Hypercholesterolaemia \> or equal to 6.5mmol/L
* Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception.
* Any condition judged by investigator that would cause the study to be detrimental to patient.
* Conditions: rheumatoid disease/other collagen vascular disease requiring therapy; diabetes mellitus; untreated hypothyroidism; inflammatory bowel disease; other respiratory disease; known alpha 1 antitrypsin deficiency; malignancy; documented history of ischaemic heart disease (IHD); cor pulmonale or known congestive heart failure; patients planning to undergo elective surgery during the study period.
* Exacerbation in the last 4 weeks.
* Significant hypoxia (PaO2 \<7.3kPa)
* Known lactose intolerance.
* Therapies: oral prednisolone for more than 1 week in the last 6 months; disease modifying drugs (Gold/ sulphasalazine etc); weight losing drugs; concomitant use of warfarin, cyclosporine; concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone). Use of any investigational drug within four weeks of the baseline visit.

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No