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The Effects of Atorvastatin Treatment in COPD Patients

Primary Purpose

COPD

Status

Completed

Phase

Phase 4

Locations

Poland

Study Type

Interventional

Intervention

Atorvastatin

Formoterol

Lactose tablet

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD, Atorvastatin, statins, COPD treatment, microarrays

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Pregnant or nursing (lactating) women
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.

Sites / Locations

Department of Lung Diseases and Tuberculosis, Medical University of Bialystok

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Atorvastatin

Lactose tablet

Arm Description

40 mg of Atorvastatin once daily as add-on to Formoterol only 12 weeks therapy.

One tablet taken once a day as add-on treatment to Formoterol baseline 12 weeks therapy.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

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.

Change in hs-CRP over study period

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

Change in total cholesterol, LDL and HDL-Cholesterol, and triglycerides measured before an after 12 weeks of therapy.

Full Information

NCT ID

NCT01748279

First Posted

December 9, 2012

Last Updated

April 21, 2013

Sponsor

Medical University of Bialystok

1. Study Identification

Unique Protocol Identification Number

NCT01748279

Brief Title

The Effects of Atorvastatin Treatment in COPD Patients

Official Title

The Effects of Atorvastatin Treatment in COPD Patients

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Bialystok

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD

Keywords

COPD, Atorvastatin, statins, COPD treatment, microarrays

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Atorvastatin

Arm Type

Active Comparator

Arm Description

40 mg of Atorvastatin once daily as add-on to Formoterol only 12 weeks therapy.

Arm Title

Lactose tablet

Arm Type

Placebo Comparator

Arm Description

One tablet taken once a day as add-on treatment to Formoterol baseline 12 weeks therapy.

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Other Intervention Name(s)

Sortis 40, manufactured by Godecke GmBH Mooswaldallee 1 790900, Freiburg, Germany

Intervention Type

Drug

Intervention Name(s)

Formoterol

Other Intervention Name(s)

Foradil, Novartis,

Intervention Description

12mcg of Foradil BID as maintenance COPD treatment in both treatment arms

Intervention Type

Drug

Intervention Name(s)

Lactose tablet

Intervention Description

One lactose tablet taken once a day as add-on treatment to Formoterol therapy

Primary Outcome Measure Information:

Title

Change in CD45+ cells expression over study period

Description

Change in CD45+ cells expression measured by immunohistochemistry in lung biopsy samples assessed before and after 12 weeks of treatment

Time Frame

12 weeks

Title

Change in gene expression over study period

Description

Change in gene expression measured in lung biopsy samples measured using microarrays before and after 12 weeks of treatment

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change in health related quality of life over study period

Description

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

Title

Change in 6-Minute Walk Distance over study period

Description

Change in 6-Minute Walk Distance measured according to 6-MWD protocol before and after 12 weeks of treatment

Time Frame

12 weeks

Title

Change in intimal-medial thickness over study period

Description

Change in intimal-medial thickness (IMT) measured in the common carotid artery (CCA) using a standard technique.

Time Frame

12 weeks

Title

Change in hs-CRP over study period

Description

Change in serum hs-C-reactive protein (hs-CRP) measured before and after 12 weeks of therapy

Time Frame

12 weeks

Title

Change in total cholesterol, LDL and HDL-Cholesterol and triglycerides over study period

Description

Change in total cholesterol, LDL and HDL-Cholesterol, and triglycerides measured before an after 12 weeks of therapy.

Time Frame

12 weeks

Other Pre-specified Outcome Measures:

Title

Change in lung volumes over study period

Description

Change in lung volumes measured using body plethysmography before and after 12 weeks of treatment

Time Frame

12 weeks

Title

Change in FEV1 over study period

Description

Change in FEV1 measured using spirometry before and after 12 weeks of treatment

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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 Pregnant or nursing (lactating) women 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert M Mroz, MD

Organizational Affiliation

Medical University of Bialystok, Bialystok, Poland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Lung Diseases and Tuberculosis, Medical University of Bialystok

City

Bialystok

ZIP/Postal Code

15-540

Country

Poland

12. IPD Sharing Statement

Citations:

PubMed Identifier

25716971

Citation

Mroz RM, Lisowski P, Tycinska A, Bierla J, Trzeciak PZ, Minarowski L, Milewski R, Lisowska A, Boros P, Sobkowicz B, Duszewska AM, Chyczewska E, Musial WJ, MacNee W. Anti-inflammatory effects of atorvastatin treatment in chronic obstructive pulmonary disease. A controlled pilot study. J Physiol Pharmacol. 2015 Feb;66(1):111-28.

Results Reference

derived

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The Effects of Atorvastatin Treatment in COPD Patients

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