Rationale: Retrospective studies suggest that statins improve outcomes in COPD patients possibly as a result of an anti-inflammatory effect. Objectives: To determine whether statins have an anti-inflammatory effect on the lungs of patients with COPD. A controlled, parallel group study to compare the effects of Atorvastatin in comparison to placebo as an add-on treatment to Formoterol therapy in patients with mild to moderate COPD in group of 20 patients. All subjects will have spirometry, lung volumes, DLCO, SGRQ, 6MWD, serum lipids and hs-CRP measured before and after treatment. Bronchoscopy and transbronchial lung biopsy (TBB) will be carried out at baseline and after 12 weeks of treatment, and TBB specimens will be processed for histology, immunohistochemistry and microarray analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
18
12mcg of Foradil BID as maintenance COPD treatment in both treatment arms
One lactose tablet taken once a day as add-on treatment to Formoterol therapy
Department of Lung Diseases and Tuberculosis, Medical University of Bialystok
Bialystok, Poland
Change in CD45+ cells expression over study period
Change in CD45+ cells expression measured by immunohistochemistry in lung biopsy samples assessed before and after 12 weeks of treatment
Time frame: 12 weeks
Change in gene expression over study period
Change in gene expression measured in lung biopsy samples measured using microarrays before and after 12 weeks of treatment
Time frame: 12 weeks
Change in health related quality of life over study period
Change in health related quality of life assessed by St. George's respiratory questionnaire before and after 12 weeks of treatment
Time frame: 12 weeks
Change in 6-Minute Walk Distance over study period
Change in 6-Minute Walk Distance measured according to 6-MWD protocol before and after 12 weeks of treatment
Time frame: 12 weeks
Change in intimal-medial thickness over study period
Change in intimal-medial thickness (IMT) measured in the common carotid artery (CCA) using a standard technique.
Time frame: 12 weeks
Change in hs-CRP over study period
Change in serum hs-C-reactive protein (hs-CRP) measured before and after 12 weeks of therapy
Time frame: 12 weeks
Change in total cholesterol, LDL and HDL-Cholesterol and triglycerides over study period
Change in total cholesterol, LDL and HDL-Cholesterol, and triglycerides measured before an after 12 weeks of therapy.
Time frame: 12 weeks
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