Clinical trial of statins CAncer preventive and Pleiotropic TherApy IN smokers with chronic obstructive pulmonary disease (COPD)

Prior treatment

• Subject has known active malignancy of any organ system, i.e., clinical evidence of current malignancy or not in stable remission for at least 5 years since completion of last treatment with exception of non-invasive basal cell carcinoma, squamous cell carcinoma of the skin or cervical intraepithelial neoplasia.
• 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 visit 1.
• 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.
• Statin use within the last 3 months prior to study start.
• 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.
• Prior diagnosis of statin induced myopathy or hypersensitivity reaction to another HMG-CoA-reductase inhibitor.

Other illness

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

Lab values

• CPK levels significantly elevated (> 5 times ULN).
• Patients with a clinically relevant laboratory abnormality at visit 1 in investigator opinion.

Other

• 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.
• Using e-cigarettes or IQOS tobacco heating system.
• Pregnant or nursing (lactating) women.
• Women of childbearing 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.

• 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 or severe COPD exacerbations, or at least one leading to hospitalization or ICU admission within 12 months, proceeding screening visit.
• Current or ex-smokers who have a smoking history of at least 10 pack years [only use of e-cigarettes or IQOS tobacco heating system cannot be use as a equivalent of classic cigarettes smoking].