Clinical trial NCT01748279: The Effects of Atorvastatin Treatment in COPD Patients
Official title: The Effects of Atorvastatin Treatment in COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
Keywords: COPD
Atorvastatin
statins
COPD treatment
microarrays
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
First posted: 2012-12-12
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

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.

Primary outcomes:
measure: Change in CD45+ cells expression over study period
timeFrame: 12 weeks
measure: Change in gene expression over study period
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in health related quality of life over study period
timeFrame: 12 weeks
measure: Change in 6-Minute Walk Distance over study period
timeFrame: 12 weeks
measure: Change in intimal-medial thickness over study period
timeFrame: 12 weeks
measure: Change in hs-CRP over study period
timeFrame: 12 weeks
measure: Change in total cholesterol, LDL and HDL-Cholesterol and triglycerides over study period
timeFrame: 12 weeks
Other outcomes:
measure: Change in lung volumes over study period
timeFrame: 12 weeks
measure: Change in FEV1 over study period
timeFrame: 12 weeks
Locations:
city: Bialystok
country: Poland
facility: Department of Lung Diseases and Tuberculosis, Medical University of Bialystok
Study officials:
affiliation: Medical University of Bialystok, Bialystok, Poland
name: Robert M Mroz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.