The Effect of Statins in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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ClinicalTrials.gov Identifier: NCT01151306 |
Recruitment Status
:
Completed
First Posted
: June 28, 2010
Last Update Posted
: March 24, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease | Drug: Simvastatin Drug: Lactose tablet | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 70 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The Cardiovascular and Inflammatory Effects of Statin Therapy in Patients With COPD |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | August 2013 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Lactose tablet |
Drug: Lactose tablet
One tablet taken each evening for 6 weeks
|
Active Comparator: Simvastatin 20mg |
Drug: Simvastatin
Simvastatin 20mg once daily (in the evening) for 6 weeks
|
- Change in arterial stiffness as measured by aortic pulse wave velocity (PWV) over study period [ Time Frame: Week 0 (start) and week 6 (end) ]Aortic Pulse wave velocity (Sphygmocor, Atcor)
- Change in Circulating Inflammatory Mediators over study period [ Time Frame: Week 0 (Start) and week 6 (End) ]
- Change in distance (metres)walked on 6 minute walking test [ Time Frame: week 0 (start) and week 6 (end) ]together with pre- and post-walk oxygen saturations
- Change in blood total cholesterol, triglycerides, HDL and LDL over study period [ Time Frame: week 0 (Start) and week 6 (End) ]
- Change in airway inflammatory markers (differential cell count, exhaled nitric oxide and airway cytokines) over study period [ Time Frame: week 0 and week 6 ]
- Change in lung function: Spirometry - forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) [ Time Frame: week 0 (Start) and week 6 (End) ]
- Change on blood pressure over study period [ Time Frame: Week 0 (start) and Week 6 (end) ]
- Change in Liver function tests [ Time Frame: Week 0 (start) and Week 6 (End) ]
- Change in creatine phosphokinase (CPK) over study period [ Time Frame: Week 0 (start) and Week 6(End) ]
- Change in Handgrip strength over study period [ Time Frame: Week 0 (start) and Week 6 (end) ]
- Change in blood desmosine over study period [ Time Frame: Week 0 (Start) and Week 6 (end) ]
- Change in circulating matrix metalloproteinase over study period [ Time Frame: Week 0 (start) and Week 6 (end) ]
- Baseline arterial stiffness (aortic pulse wave velocity) [ Time Frame: Week 0 ]
- Baseline airway (differential cell count, exhaled nitric oxide and cytokines)and circulating inflammatory status (cytokines) [ Time Frame: Week 0 ]
- Baseline matrix metalloproteinase in airway and blood [ Time Frame: Week 0 ]

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Ages Eligible for Study: | 45 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151306
United Kingdom | |
Nottingham Respiratory Biomedical Research Unit | |
Nottingham, United Kingdom, NG5 1PB |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | University of Nottingham |
ClinicalTrials.gov Identifier: | NCT01151306 History of Changes |
Other Study ID Numbers: |
09105 |
First Posted: | June 28, 2010 Key Record Dates |
Last Update Posted: | March 24, 2014 |
Last Verified: | March 2014 |
Additional relevant MeSH terms:
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Simvastatin Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |