The Cardiovascular and Inflammatory Effects of Statin Therapy in Patients with COPD - The Effect of Statins in Patients with COPD

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)

• Registration Number: EUCTR2009-017689-22-GB
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-18
• Study Completion: 2012-12-28
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

1) Male or female patients aged 45-80 years;
2) Confirmed COPD: FEV1 30-80% predicted, FEV1/FVC<0.7, salbutamol reversibility <12%, supportive smoking history;
3) 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);
4) Able to attend for regular clinic appointments;
5) In opinion of investigator, the patient will be able to comply with the requirements of the protocol;
6) Provide written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Known hypersensitivity to or side effects relating to previous statin treatment, or current therapy which includes a statin, ezetimibe or fibrate;
2) Clinically significant liver function abnormality; alcohol excess (defined as >21 units per week for males or 14 units for females);
3) Hypercholesterolaemia > or equal to 6.5 mmmol/L;
4) Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception;
5) Any condition judged by investigator that would cause the study to be detrimental to patient;
6) Conditions: rheumatoid disease/other collagen vascular disease requiring therapy; diabetes mellitus; untreated hypothyroidism; inflammatory bowel disease; other respiratory disease; malignancy; documented history of IHD; cor pulmonale or known congestive heart failure; known alpha 1 antitrypsin deficiency; patients planning to undergo elective surgery during the study period.
7) Exacerbation in the last 4 weeks;
8) Significant hypoxia (PaO2 <7.3kPa);
9) Lactose intolerance
10) 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 and cyclosporine. Use of any investigational drug within four weeks of the baseline visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified