Atorvastatin Effect on Reduction of COPD Exacerbations

Prior treatment

• Statin use within the last 3 months prior to study start.
• Prior diagnosis of statin induced myopathy or hypersensitivity reaction to another HMG-CoA-reductase inhibitor.
• 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.
• Patients who have had a respiratory tract infection within 4 weeks prior to visit1.
• Patients requiring oxygen therapy (\>15hr/day) on a daily basis for chronic hypoxemia.
• Patients with a history of asthma or onset of symptoms prior to age 40 years
• Patients with concomitant pulmonary disease (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, tuberculosis).
• Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation.
• Active abuse of drugs or alcohol, poor compliance anticipated.
• 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.
• Use of other investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening visit.

Other illness

• Contraindication to statin therapy included but not limited to: known poliomyelitis, motor neuron disease, cranial or temporal arteritis, stroke or myopathy.
• Patients with a history of malignancy of any organ system (including lung cancer).

Lab values

• Patients with a clinically relevant laboratory abnormality at visit 1 in investigator opinion.

Other

• Using e-cigarettes or I IQOS tobacco heating system.
• Pregnant or nursing (lactating) women.
• Women of child bearing potential, unless they are using effective method of contraception during dosing of study treatment.
• Patient with a clinically significant abnormality at visit 1 in investigator opinion.
• Patients unable to perform acceptable spirometry and lung volumes procedures.
• Patients with primary bronchiectasis.
• Patients with a diagnosis of α-1 antitrypsin deficiency (AATD).
• Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study.
• Those unable in the opinion of the Investigator to comply fully with the study requirements.

• Subject has signed Informed Consent Form and is able to understand the purpose and procedures required for the study and is willing to participate in the study.
• Subject \[male or female\] is aged 40 years and older.
• Subject is able to understand and comply with the protocol requirements and instructions and is likely to complete the study as planned.
• Patients with stable COPD with persistent airflow limitation (stable COPD (post-bronchodilator FEV1\<80% of the predicted normal and post-bronchodilator FEV1/FVC\<0,70 at visit 1.) Stage II- IV) and with moderate to very severe airflow limitation according to GOLD guidelines.
• At least two moderate/severe COPD exacerbations, or at least one leading to hospitalization or ICU admission within 12 months, preceding screening visit.
• Current or ex-smokers who have a smoking history of at least 10 pack years.