Chronic obstructive pulmonary disease MedDRA version: 9.1 Level: LLT Classification code 10009026 Term: Chronic obstructive airways disease
Conditions
Interventions
Trade Name: RiteChol
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
University of East Anglia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, aged more than 45 years. 2. Physician labelled diagnosis of chronic obstructive pulmonary disease, emphysema or chronic bronchitis. 3. Smoker or ex-smoker with a pack year smoking history of greater than 20 pack years 4. FEV1 30-70% predicted 5. FEV1/FVC=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Cardiac or pulmonary disease other than chronic obstructive pulmonary disease. 2. Untreated hypothyroidism 3. Respiratory infection defined as fever, nasal/sinus congestion, fatigue, cough, antibiotic use or yellow/green sputum within 4 weeks prior to study. 4. Receiving current oral corticosteroid therapy or leukotriene modifying therapy. 5. Severe or uncontrolled co-morbid disease 6. History of atopy or asthma 7. Clinical history of bronchiectasis 8. Pregnancy or breastfeeding. 9. Unable to give written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: ;Primary end point(s): The difference in serum high sensitivity C-reactive protein (HsCRP) between treatment with simvastatin and placebo. | — |
Countries
United Kingdom
Outcome results
None listed