Atorvastatin Effect on Reduction of COPD Exacerbations

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 another HMG-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 of contraception during dosing of study treatment.
• •7. Patient with a clinically significant abnormality at visit 1 in investigator opinion.
• •8. Patients with a clinically relevant laboratory abnormality at visit 1 in investigator 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 antibiotics and/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 chronic hypoxemia.
• •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 lung transplantation.
• •19. Active abuse of drugs or alcohol, poor compliance anticipated.
• •20. Use concomitant medications that are known to interact with atorvastatin: warfarin and other coumarin (vitamin K antagonists) anticoagulants, cyclosporin, gemfibrozil or other non or selective nonsteroidal anti-inflammatory drugs, proton pump inhibitors (PPIs) used by last 6 months.
• •21. Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study.
• •22. Use of other investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening visit.
• •23. Those unable in the opinion of the Investigator to comply fully with the study requirements.