Atorvastatin Effect on Reduction of COPD Exacerbations

Inclusion Criteria:

1. Subject has signed Informed Consent Form and is able to understand the purpose andprocedures required for the study and is willing to participate in the study.

2. Subject [male or female] is aged 40 years and older.

3. Subject is able to understand and comply with the protocol requirements andinstructions and is likely to complete the study as planned.

4. Patients with stable COPD with persistent airflow limitation (stable COPD (post-bronchodilator FEV1<80% of the predicted normal and post-bronchodilatorFEV1/FVC<0,70 at visit 1.) Stage II- IV) and with moderate to very severe airflowlimitation according to GOLD guidelines.

5. At least two moderate/severe COPD exacerbations, or at least one leading tohospitalization or ICU admission within 12 months, preceding screening visit.

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

Exclusion Criteria:

1. Contraindication to statin therapy included but not limited to: known poliomyelitis,motor neuron disease, cranial or temporal arteritis, stroke or myopathy.

2. Statin use within the last 3 months prior to study start.

3. Prior diagnosis of statin induced myopathy or hypersensitivity reaction to anotherHMG-CoA-reductase inhibitor.

4. Using e-cigarettes or I IQOS tobacco heating system.

5. Pregnant or nursing (lactating) women.

6. Women of child bearing potential, unless they are using effective method ofcontraception during dosing of study treatment.

7. Patient with a clinically significant abnormality at visit 1 in investigatoropinion.

8. Patients with a clinically relevant laboratory abnormality at visit 1 ininvestigator opinion.

9. Patients with a history of malignancy of any organ system (including lung cancer).

10. Patients unable to perform acceptable spirometry and lung volumes procedures.

11. Patients who had a COPD exacerbations that required treatment with antibioticsand/or oral corticosteroids and/or hospitalization in the 6 weeks prior to visit 1.

12. Patients who have had a respiratory tract infection within 4 weeks prior to visit1.

13. Patients requiring oxygen therapy (>15hr/day) on a daily basis for chronichypoxemia.

14. Patients with a history of asthma or onset of symptoms prior to age 40 years

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

16. Patients with primary bronchiectasis.

17. Patients with a diagnosis of α-1 antitrypsin deficiency (AATD).

18. Patients with pulmonary lobectomy or lung volume reduction surgery or lungtransplantation.

19. Active abuse of drugs or alcohol, poor compliance anticipated.

20. Use concomitant medications that are known to interact with atorvastatin: warfarinand other coumarin (vitamin K antagonists) anticoagulants, cyclosporin, gemfibrozilor other non or selective nonsteroidal anti-inflammatory drugs, proton pumpinhibitors (PPIs) used by last 6 months.

21. Patients participating in or planning to participate in the active phase of asupervised pulmonary rehabilitation program during the study.

22. Use of other investigational drugs within 30 days or 5 half-lives, whichever islonger, prior to screening visit.

23. Those unable in the opinion of the Investigator to comply fully with the studyrequirements.