ATORVASTATIN for Chronic obstructive pulmonary disease

Inclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- Subject [male or female] is aged 40 years and older."}
• {"criterion_text":"- Subject is able to understand and comply with the protocol requirements and instructions and is likely to complete the study as planned."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- At least two moderate or severe COPD exacerbations, or at least one leading to hospitalization or ICU admission within 12 months, proceeding screening visit."}
• {"criterion_text":"- 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 criteria

• {"criterion_text":"- Contraindication to statin therapy included but not limited to: known poliomyelitis, motor neuron disease, cranial or temporal arteritis, stroke or myopathy."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Patients unable to perform acceptable spirometry and lung volumes procedures."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Patients who have had a respiratory tract infection within 4 weeks prior to visit 1."}
• {"criterion_text":"- Patients requiring oxygen therapy (>15hr/day) on a daily basis for chronic hypoxemia."}
• {"criterion_text":"- Patients with a history of asthma or onset of symptoms prior to age 40 years."}
• {"criterion_text":"- Patients with concomitant pulmonary disease (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, tuberculosis)."}
• {"criterion_text":"- Patients with primary bronchiectasis."}
• {"criterion_text":"- Patients with a diagnosis of α-1 antitrypsin deficiency (AATD)."}
• {"criterion_text":"- Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation."}
• {"criterion_text":"- Statin use within the last 3 months prior to study start."}
• {"criterion_text":"- Active abuse of drugs or alcohol, poor compliance anticipated."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study."}
• {"criterion_text":"- Use of other investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening visit."}
• {"criterion_text":"- Those unable in the opinion of the Investigator to comply fully with the study requirements."}
• {"criterion_text":"- Prior diagnosis of statin induced myopathy or hypersensitivity reaction to another HMG-CoA-reductase inhibitor."}
• {"criterion_text":"- CPK levels significantly elevated (> 5 times ULN)."}
• {"criterion_text":"- Using e-cigarettes or IQOS tobacco heating system."}
• {"criterion_text":"- Pregnant or nursing (lactating) women."}
• {"criterion_text":"- Women of childbearing potential, unless they are using effective method of contraception during dosing of study treatment."}
• {"criterion_text":"- Patient with a clinically significant abnormality at visit 1 in investigator opinion."}
• {"criterion_text":"- Patients with a clinically relevant laboratory abnormality at visit 1 in investigator opinion."}

Primary endpoints

• {"endpoint_text":"- Exacerbation rate","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to exacerbation","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Duration of exacerbation","definition_or_measurement_approach":""}
• {"endpoint_text":"- Changes in forced expiratory volume in the first second (FEV1)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Changes in health-related quality of life (SGRQ score)","definition_or_measurement_approach":"Measured by SGRQ (Saint George's Respiratory Questionnaire) score as specified in the endpoint text."}
• {"endpoint_text":"- Changes in inflammatory pathway gene expression in the PBMCs by whole transcriptome RNA-seq analysis.","definition_or_measurement_approach":"Assessed by whole transcriptome RNA-seq analysis of PBMCs as specified in the endpoint text."}
• {"endpoint_text":"- Changes in blood inflammatory markers (Peripheral blood leucocyte count, fibrinogen, Interleukin-6, high sensitivity C – reactive protein)","definition_or_measurement_approach":"Measured by blood assays for peripheral blood leucocyte count, fibrinogen, IL-6, and high-sensitivity CRP as listed in the endpoint text."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Assessed by plethysmography measuring FRC, IC and DLCO as specified in the endpoint text."}
• {"endpoint_text":"- 6 minute walking distance (6MWD) and the rate of hospitalizations","definition_or_measurement_approach":"6MWD measured using 6-minute walk test; hospitalizations counted/rated as specified in endpoint text."}
• {"endpoint_text":"- Changes in vital signs (blood pressure, HR), and/or laboratory findings.","definition_or_measurement_approach":"Measured via standard vital signs assessments (blood pressure, heart rate) and laboratory tests."}
• {"endpoint_text":"- The rate of hospitalization (pulmonary or MACE)","definition_or_measurement_approach":"Rate assessed by counting hospitalizations for pulmonary causes or MACE as specified in the endpoint text."}

Poland

Earliest CTIS Part Ii Submission Date

28-10-2024

Latest Decision Or Authorization Date

02-12-2024

Processing Time Days

35

Number Of Sites

12

Number Of Participants

480

Primary sponsor

Full Name

Medical University Of Bialystok

Organisation Type

Educational Institution

Country Of Registered Address

Poland

Contract research organisations

Name

Scientia CRO Sp. z o.o.

Responsibilities

sponsor duties codes: 1,10,11,12,2,3,6,7,8,9; contact beata.maciejewska@scientiacro.com

Third parties

• {"country":"Poland","full_name":"Scientia CRO Sp. z o.o.","duties_or_roles":"sponsor duties codes: 1,10,11,12,2,3,6,7,8,9","organisation_type":"Pharmaceutical company"}
• {"country":"Poland","full_name":"Medicofarma Biotech S.A.","duties_or_roles":"repackaging of IMP, manufacturing of the placebo","organisation_type":"Pharmaceutical company"}
• {"country":"Poland","full_name":"Clean Data Labs Sp. z o.o.","duties_or_roles":"Supplier eCRF","organisation_type":"Industry"}
• {"country":"Poland","full_name":"Cefea Sp. z o.o. S.K.","duties_or_roles":"IMP storage and distribution","organisation_type":"Pharmaceutical company"}