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The Effects of Atorvastatin Treatment in COPD Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert M. Mroz, Medical University of Bialystok
ClinicalTrials.gov Identifier:
NCT01748279
First received: December 9, 2012
Last updated: April 21, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
COPD
Drug: Atorvastatin
Drug: Formoterol
Drug: Lactose tablet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effects of Atorvastatin Treatment in COPD Patients

Resource links provided by NLM:


Further study details as provided by Medical University of Bialystok:

Primary Outcome Measures:
  • Change in CD45+ cells expression over study period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in CD45+ cells expression measured by immunohistochemistry in lung biopsy samples assessed before and after 12 weeks of treatment

  • Change in gene expression over study period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in gene expression measured in lung biopsy samples measured using microarrays before and after 12 weeks of treatment


Secondary Outcome Measures:
  • Change in health related quality of life over study period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in health related quality of life assessed by St. George's respiratory questionnaire before and after 12 weeks of treatment

  • Change in 6-Minute Walk Distance over study period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in 6-Minute Walk Distance measured according to 6-MWD protocol before and after 12 weeks of treatment

  • Change in intimal-medial thickness over study period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in intimal-medial thickness (IMT) measured in the common carotid artery (CCA) using a standard technique.

  • Change in hs-CRP over study period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in serum hs-C-reactive protein (hs-CRP) measured before and after 12 weeks of therapy

  • Change in total cholesterol, LDL and HDL-Cholesterol and triglycerides over study period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in total cholesterol, LDL and HDL-Cholesterol, and triglycerides measured before an after 12 weeks of therapy.


Other Outcome Measures:
  • Change in lung volumes over study period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in lung volumes measured using body plethysmography before and after 12 weeks of treatment

  • Change in FEV1 over study period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Change in FEV1 measured using spirometry before and after 12 weeks of treatment


Enrollment: 18
Study Start Date: December 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Atorvastatin
40 mg of Atorvastatin once daily as add-on to Formoterol only 12 weeks therapy.
Drug: Atorvastatin
Other Names:
  • Sortis 40, manufactured by Godecke GmBH Mooswaldallee 1 790900
  • Freiburg, Germany
Drug: Formoterol
12mcg of Foradil BID as maintenance COPD treatment in both treatment arms
Other Name: Foradil, Novartis,
Placebo Comparator: Lactose tablet
One tablet taken once a day as add-on treatment to Formoterol baseline 12 weeks therapy.
Drug: Formoterol
12mcg of Foradil BID as maintenance COPD treatment in both treatment arms
Other Name: Foradil, Novartis,
Drug: Lactose tablet
One lactose tablet taken once a day as add-on treatment to Formoterol therapy

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

. Written informed consent must be obtained before any assessment is performed. 2. Male and female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.

3. Patients with moderate to very severe stable COPD (Stage II-IV) according to the GOLD guidelines.

4. Patients with a post-bronchodilator FEV1 < 80% of the predicted normal, and a post-bronchodilator FEV1/FVC < 0.70 at Visit 1.

5. Current or ex-smokers who have a smoking history of at least 10 pack years

Exclusion criteria

  1. Pregnant or nursing (lactating) women
  2. Women of child-bearing potential, unless they are using effective methods of contraception during dosing of study treatment. 5. 3. Patients with a clinically significant abnormality at Visit 1.

4. Patients with a clinically relevant laboratory abnormality at Visit 1 5. Patients with a history of malignancy of any organ system (including lung cancer).

6. Patients contraindicated for treatment with statins 7. Patients unable to perform acceptable spirometry and lung volumes procedures.

8. Patients who have had a COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 6 weeks prior to Visit 1.

9. Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1.

10. Patients requiring oxygen therapy (>15 hr/day) on a daily basis for chronic hypoxemia 11. Patients with any history of asthma or onset of symptoms prior to age 40 years.

12. Patients with concomitant pulmonary disease, (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, tuberculosis).

13. Patients with primary bronchiectasis. 14. Patients with a diagnosis of α-1 anti-trypsin deficiency. 15. Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation.

16. Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study.

17. Patients receiving any medications in the class listed in Table 5.1 18. Use of other investigational drugs within 30 days prior to visit 1.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748279

Locations
Poland
Department of Lung Diseases and Tuberculosis, Medical University of Bialystok
Bialystok, Poland, 15-540
Sponsors and Collaborators
Medical University of Bialystok
Investigators
Principal Investigator: Robert M Mroz, MD Medical University of Bialystok, Bialystok, Poland
  More Information

No publications provided

Responsible Party: Robert M. Mroz, Associate Professor, Medical University of Bialystok
ClinicalTrials.gov Identifier: NCT01748279     History of Changes
Other Study ID Numbers: 113-46-966, N N402 593440
Study First Received: December 9, 2012
Last Updated: April 21, 2013
Health Authority: Poland: Ethics Committee
Poland: Ministry of Science and Higher Education

Keywords provided by Medical University of Bialystok:
COPD
Atorvastatin
statins
COPD treatment
microarrays

Additional relevant MeSH terms:
Atorvastatin
Formoterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Anticholesteremic Agents
Antimetabolites
Autonomic Agents
Bronchodilator Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014