Respiratory Tract (Lung and Bronchial) Diseases

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Symptoms and General Pathology

Rare Diseases

Lung Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Respiratory Tract Diseases

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Lipid Regulating Agents

All Drugs and Chemicals

Atorvastatin

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Enzyme Inhibitors

Atorvastatin 40 Mg Oral Tablet

Placebo

Robert Mróz, Prof. MD

Robert Mróz, Professor

It is a randomized, multicenter, prospective, double-blind, placebo controlled, interventional clinical trial that will be conducted in Poland, in about 12 Hospital Pulmonary Departments to evaluate the effectiveness of atorvastatin on the reduction of inflammation process in patients with chronic obstructive pulmonary diseases, and possible biomarkers for personalized treatment of COPD.

It will be a randomized, double-blind, two arm clinical study to assess effect of atorvastatin 40 mg treatment in patients with stable COPD. The whole study duration will include three phases: pre-study screening and enrollment procedures (4 weeks), clinical assessment at dosing (52 weeks), and post study follow up (4 weeks). During the participation in the study subjects will attend Visit 1 (V1, -4 weeks), visit 2 (V2, day 0), visit 3 (V3, week6), visit 4 (V4, week 12), visit 5 (V5, week 26), visit 6 (V6, week 38), visit 7 (V7, week 52), and follow-up end of study visit (EOS, 56 weeks). The study will begin with a 4-weeks screening phase where patients who fulfill preliminary inclusion/exclusion criteria (prior to entry into study), will be given informed consent and screened. The baseline laboratory tests, clinical and medical evaluation including concomitant medication and drug of abuse will be completed to determine patient continuing eligibility to participate in the study.

Upon confirmation of eligibility, the patients will be randomized into two treatment groups receiving one of two medications tested in the study. Each patient enrolled into the clinical study will have to report to the clinic 7 times in order to complete procedures. Blood will be drawn before and during the statin or placebo treatment from patients according to study protocol. This part of the project aims to develop statin response biomarkers for personalized treatment of COPD, based on RNA-sequencing (RNA-seq) information derived from, leukocytes and blood plasma of COPD patients with characterized clinical Atorvastatin response phenotypes.

Atorvastatin Effect on Reduction of COPD Exacerbations

Non-commercial Clinical Trial of Statins CAncer Preventive and Pleiotropic TherApy IN Smokers With Chronic Obstructive Pulmonary Disease (COPD)

According to the agreement with the funding institution (Medical Research Agency), the sponsor and research centers must obtain the consent of the funding institution to disclose the clinical trial data.

The functional residual volume (FRC) will be evaluated at Visit 2, Visit 5 and Visit 7, and changes from Visit 1 will be calculated, as well as compared between studied groups.

The Inspiratory capacity (IC) will be evaluated will be evaluated at Visit 2, Visit 5 and Visit 7, and changes from Visit 1 will be calculated, as well as compared between studied groups.

The 6MWD tests will be performed at Visit 2, Visit 5 and Visit 7, and changes from Visit 1 will be calculated, as well as compared between studied groups.

The number of hospitalizations during the treatment and follow-up phases will be evaluated, and compared between studied groups.

The changes in blood pressure from Visit 1 will be evaluated at Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7, and changes from Visit 1 will be calculated, as well as compared between studied groups.

The changes in HR from Visit 1 will be evaluated at Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7, and changes from Visit 1 will be calculated, as well as compared between studied groups.

The changes in hematology results from visit Visit 1 will be evaluated, at Visit 3, Visit 5, and Visit 7, as well as the differences between studied groups will be compared.

The changes in biochemistry results from visit Visit 1 will be evaluated, at Visit 3, Visit 5, and Visit 7, as well as the differences between studied groups will be compared.

The changes in lipids profile results from visit Visit 1 will be evaluated, at Visit 3, Visit 5, and Visit 7, as well as the differences between studied groups will be compared.

The changes in blood glucose concentrations from Visit 1 will be evaluated at Visit 7, and compared between studied groups.

The changes in HbA1c levels from Visit 1 will be evaluated at Visit 7, and compared between studied groups.

The changes in blood AspAT and ALAT concentrations from Visit 1 will be evaluated, at Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7, and compared between studied groups.

The changes in blood CPK concentrations from Visit 1 will be evaluated, at Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 and Visit 7, and compared between studied groups.

The DLCO will be evaluated at Visit 2, Visit 5 and Visit 7, and the changes from Visit 1 will be calculated, as well as compared between studied groups.

The exacerbation of the disease (defined as an acute worsening of respiratory symptoms that results in additional therapy) will be measured during the study treatment and follow-up phases, and compared between studied groups.

The time to the first exacerbation will be compared between the Intervention and Placebo groups.

The differences in absolute value between Placebo and Atorvastatin group will be evaluated in time points \[Visit 1 ,Visit 3,Visit 4, Visit 5, Visit 6 and Visit 8\], and the relative change between Visit 1 and following time points \[Visit 3 - Visit 8\] in both arms will be compared.

The St George's Respiratory Questionnaire (SGRQ) score will be used and the differences in absolute value between Placebo and Atorvastatin group will be evaluated in time points \[Visit 2 , Visit 5, and Visit 7\], as well as the - relative change between Visit 2 and following time points \[Visit 5 and Visit 7\] in both arms will be compared. Scores range from 0 to 100; higher scores indicating more limitations.

The gene expression will be evaluated in the peripheral blood leucocytes (PBL) by RNA-seq analysis, at visit Visit 1, Visit 2, Visit 5 and Visit 7, and the differences between Placebo and Atorvastatin groups will be analyzed, as well as a relative change between visits Visit 1 and Visit 2, Visit 5 and Visit 7 in both arms will be compared.

The peripheral blood leucocytes count will be measured and the differences in absolute values between Placebo and Atorvastatin group will be calculated in time points Visit 1 ,Visit 3, Visit 5 and Visit 7, as well as a relative change between visits Visit 1 and Visit 2, Visit 3, Visit 5 , Visit 7 in both arms will be compared.

A blood fibrinogen concentration will be measured and the differences in absolute values between Placebo and Atorvastatin group will be calculated in time points Visit 1 ,Visit 3, Visit 5 and Visit 7, as well as a relative change between visits Visit 1 and Visit 2, Visit 3, Visit 5 , Visit 7 in both arms will be compared.

The Interleukin-6 blood concentrations will be measured and the differences in absolute values between Placebo and Atorvastatin group will be calculated in time points Visit 1 ,Visit 3, Visit 5 and Visit 7, as well as a relative change between visits Visit 1 and Visit 2, Visit 3, Visit 5 , Visit 7 in both arms will be compared.

The blood high sensitivity C - reactive protein concentrations will be measured and the differences in absolute values between Placebo and Atorvastatin group will be calculated in time points Visit 1 ,Visit 3, Visit 5 and Visit 7, as well as a relative change between visits Visit 1 and Visit 2, Visit 3, Visit 5 , Visit 7 in both arms will be compared.

Spots Global Cancer Trial Database for atorvastatin 40 mg oral tablet