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

Trial details

Who runs it

Medical University Of Bialystok

Trial code

EU 2024-516714-37-00

Record updated

2024. december 2.

Original description

The primary objective of clinical part of this study is to compare the effectiveness of atorvastatin with a matched placebo control on the reduction of COPD exacerbations in patients with chronic obstructive pulmonary diseases.Read full original descriptionShow less

Non-commercial clinical trial of statins CAncer preventive and Pleiotropic TherApy IN smokers with chronic obstructive pulmonary disease (COPD) Clinical part: Atorvastatin effect on reduction of COPD exacerbations. Genomic part: Assessment of immunobiology of COPD related lung carcinoma and inflammatory pathways activation based on gene expression profiles of the peripheral blood leukocytes (PBLs) and peripheral blood mononuclear cells (PBMCs) from smokers with chronic obstructive pulmonary disease (COPD).

The primary objective of clinical part of this study is to compare the effectiveness of atorvastatin with a matched placebo control on the reduction of COPD exacerbations in patients with chronic obstructive pulmonary diseases.

Inclusion: 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].

Exclusion: 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; Contraindication to statin therapy included but not limited to: known poliomyelitis, motor neuron disease, cranial or temporal arteritis, stroke or myopathy; CPK levels significantly elevated (> 5 times ULN); Patients with a clinically relevant laboratory 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; 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.

EU CTIS 2024-516714-37-00