Status:
COMPLETED
The Effect of Statins in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
University of Nottingham
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
45-80 years
Phase:
PHASE4
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01151306
Start Date
June 1 2010
End Date
August 1 2013
Last Update
March 24 2014
Active Locations (1)
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1
Nottingham Respiratory Biomedical Research Unit
Nottingham, United Kingdom, NG5 1PB