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The Effects of Atorvastatin Treatment in COPD Patients

NCT01748279 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2013-04-23

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Medical University of Bialystok

    lead OTHER

Principal Investigators

  • Robert M Mroz, MD · Medical University of Bialystok, Bialystok, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01748279 on ClinicalTrials.gov