Atorvastatin Effect on Reduction of COPD Exacerbations (NCT04789057) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Atorvastatin Effect on Reduction of COPD Exacerbations
Poland460 participantsStarted 2022-02-11
Plain-language summary
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.
Who can participate
Age range40 Years – 99 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Contraindication to statin therapy included but not limited to: known poliomyelitis, motor neuron disease, cranial or temporal arteritis, stroke or myopathy.
✕. 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.
✕. Using e-cigarettes or I IQOS tobacco heating system.