Simvastatin in Chronic Obstructive Pulmonary Disease (COPD)

• Status: Unknown status
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the effects of 2 months therapy with simvastatin 40mg once per day compared to placebo in a double-blind placebo-controlled study of patients with COPD.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of East Anglia
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

• Male or female, aged more than 45 years.

• Physician labelled diagnosis of chronic obstructive pulmonary disease,emphysema or chronic bronchitis.

• Smoker or ex-smoker with a pack year smoking history of greater than 20 pack years

• FEV1 30-70% predicted

• FEV1/FVC< 70%

• Body Mass Index <25kg/m2

Exclusion Criteria:

• 1. Cardiac or pulmonary disease other than chronic obstructive pulmonary disease.

• Untreated hypothyroidism

• Respiratory infection defined as fever, nasal/sinus congestion, fatigue, cough, antibiotic use or yellow/green sputum within 4 weeks prior to study.

• Receiving current oral corticosteroid therapy or leukotriene modifying therapy.

• Severe or uncontrolled co-morbid disease

• History of atopy or asthma

• Clinical history of bronchiectasis

• Pregnancy or breastfeeding

• Women of child-bearing potential, unless adequate contraception is used (ie contraceptive pill or double-barrier contraception - partner using condom and subject using spermicide, diaphragm, intra-uterine device or contraceptive sponge)

• Unable to give written informed consent

• Patients receiving a statin prior to entry into the study

• Hypersensitivity to simvastatin or to any of the excipients.