Status:
UNKNOWN
Simvastatin in Chronic Obstructive Pulmonary Disease (COPD)
Lead Sponsor:
University of East Anglia
Conditions:
COPD
Emphysema
Eligibility:
All Genders
45-85 years
Phase:
PHASE4
Brief 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.
Detailed Description
Statins (HMG-Coenzyme A reductase inhibitors) are widely used clinically as lipid lowering drugs; however they have also been shown to exhibit anti-inflammatory and anti-oxidant properties(1). Recentl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00680641
Start Date
April 1 2008
End Date
February 1 2012
Last Update
August 5 2011
Active Locations (2)
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1
CRTU University of East Anglia
Norwich, Norfolk, United Kingdom, NR47TJ
2
CRTU Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom, NR74UY