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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).

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516714-37-00
Acronym
2019/ABM/01/00074
Enrollment
480
Registered
2024-12-02
Start date
2022-01-19
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease (COPD)

Brief summary

Exacerbation rate, Time to exacerbation

Detailed description

Duration of exacerbation, Changes in forced expiratory volume in the first second (FEV1), Changes in health-related quality of life (SGRQ score), Changes in inflammatory pathway gene expression in the PBMCs by whole transcriptome RNA-seq analysis., Changes in blood inflammatory markers (Peripheral blood leucocyte count, fibrinogen, Interleukin-6, high sensitivity C – reactive protein), Changes from baseline in pre-dose values of plethysmography (functional residual volume (FRC), inspiratory capacity (IC), transfer factor of the lung for carbon monoxide (DLCO), 6 minute walking distance (6MWD) and the rate of hospitalizations, Changes in vital signs (blood pressure, HR), and/or laboratory findings., The rate of hospitalization (pulmonary or MACE)

Interventions

DRUGPlacebo
DRUGAtoris
DRUG40 mg

Sponsors

Medical University Of Bialystok
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Exacerbation rate, Time to exacerbation

Secondary

MeasureTime frame
Duration of exacerbation, Changes in forced expiratory volume in the first second (FEV1), Changes in health-related quality of life (SGRQ score), Changes in inflammatory pathway gene expression in the PBMCs by whole transcriptome RNA-seq analysis., Changes in blood inflammatory markers (Peripheral blood leucocyte count, fibrinogen, Interleukin-6, high sensitivity C – reactive protein), Changes from baseline in pre-dose values of plethysmography (functional residual volume (FRC), inspiratory capacity (IC), transfer factor of the lung for carbon monoxide (DLCO), 6 minute walking distance (6MWD) and the rate of hospitalizations, Changes in vital signs (blood pressure, HR), and/or laboratory findings., The rate of hospitalization (pulmonary or MACE)

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026