NCT01748279

The Effects of Atorvastatin Treatment in COPD Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Medical University of Bialystok · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• COPD

Interventions

Type	Name	Description
DRUG	Atorvastatin
DRUG	Formoterol	12mcg of Foradil BID as maintenance COPD treatment in both treatment arms
DRUG	Lactose tablet	One lactose tablet taken once a day as add-on treatment to Formoterol therapy

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-12-12
• Last updated: 2013-04-23

Locations

1 site across 1 country: Poland