The Effect of Statins in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01151306 | Completed Phase 4

• 1 other identifier: 09105
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Change in arterial stiffness as measured by aortic pulse wave velocity (PWV) over study period

  Aortic Pulse wave velocity (Sphygmocor, Atcor)

  Week 0 (start) and week 6 (end)

Secondary Outcomes (14)

• Change in Circulating Inflammatory Mediators over study period

  Week 0 (Start) and week 6 (End)

• Change in distance (metres)walked on 6 minute walking test

  week 0 (start) and week 6 (end)

• Change in blood total cholesterol, triglycerides, HDL and LDL over study period

  week 0 (Start) and week 6 (End)

• Change in airway inflammatory markers (differential cell count, exhaled nitric oxide and airway cytokines) over study period

  week 0 and week 6

• Change in lung function: Spirometry - forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC)

  week 0 (Start) and week 6 (End)

Study Arms (2)

Lactose tablet

PLACEBO COMPARATOR

Drug: Lactose tablet

Simvastatin 20mg

ACTIVE COMPARATOR

Drug: Simvastatin

Interventions

Simvastatin DRUG

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

Simvastatin 20mg

Lactose tablet DRUG

One tablet taken each evening for 6 weeks

Lactose tablet

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Nottingham Respiratory Biomedical Research Unit

Nottingham, NG5 1PB, United Kingdom

Location

Related Publications (1)

• John ME, Cockcroft JR, McKeever TM, Coward WR, Shale DJ, Johnson SR, Thornton JG, Harrison TW, Knox AJ, Bolton CE. Cardiovascular and inflammatory effects of simvastatin therapy in patients with COPD: a randomized controlled trial. Int J Chron Obstruct Pulmon Dis. 2015 Jan 29;10:211-21. doi: 10.2147/COPD.S76061. eCollection 2015.

  PMID: 25673981 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Simvastatin; Lactose

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: June 28, 2010
• Study Start: June 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: August 1, 2013
• Last Updated: March 24, 2014

Record last verified: 2014-03

Locations

GB (1)