The Effects of Atorvastatin Treatment in COPD Patients

COPD Clinical Trial

Official title:

The Effects of Atorvastatin Treatment in COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748279
• Other study ID #: 113-46-966
• Secondary ID: N N402 593440
• Status: Completed
• Phase: Phase 4
• First received: December 9, 2012
• Last updated: April 21, 2013
• Start date: December 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Medical University of Bialystok
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics CommitteePoland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 a-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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• Atorvastatin

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

Locations

Country	Name	City	State
Poland	Department of Lung Diseases and Tuberculosis, Medical University of Bialystok	Bialystok

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Bialystok

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in lung volumes over study period	Change in lung volumes measured using body plethysmography before and after 12 weeks of treatment	12 weeks	No
Other	Change in FEV1 over study period	Change in FEV1 measured using spirometry before and after 12 weeks of treatment	12 weeks	No
Primary	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	12 weeks	No
Primary	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	12 weeks	No
Secondary	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	12 weeks	No
Secondary	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	12 weeks	No
Secondary	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.	12 weeks	No
Secondary	Change in hs-CRP over study period	Change in serum hs-C-reactive protein (hs-CRP) measured before and after 12 weeks of therapy	12 weeks	No
Secondary	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.	12 weeks	No