Chronic obstructive pulmonary disease (COPD) MedDRA version: 27.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Atoris, 40mg
Pharmaceutical Form: Coated tablet
INN or Proposed INN: ATORVASTATIN
CAS Number: 134523-00-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
Medical University of Bialystok
Eligibility
Sex/Gender
All
Inclusion criteria
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. and Patients with stable COPD with persistent airflow limitation [stable COPD (post bronchodilator FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range 165
Exclusion criteria
Exclusion criteria: 1. Contraindication to statin therapy included but not limited to: known poliomyelitis, motor neuron disease, cranial or temporal arteritis, stroke or myopathy. 2. Statin use within the last 3 months prior to study start. 3. Prior diagnosis of statin induced myopathy or hypersensitivity reaction to another HMG-CoA-reductase inhibitor. 4. CPK levels significantly elevated (> 5 times ULN). 5. Using e-cigarettes or IQOS tobacco heating system. 6. Pregnant or nursing (lactating) women. 7. Women of child bearing potential, unless they are using effective method of contraception during dosing of study treatment. 8. Patient with a clinically significant abnormality at visit 1 in investigator opinion. 9. Patients with a clinically relevant laboratory abnormality at visit 1 in investigator opinion. 10. 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. 11. Patients unable to perform acceptable spirometry and lung volumes procedures. 12. 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. 13. Patients who have had a respiratory tract infection within 4 weeks prior to visit 1. 14. Patients requiring oxygen therapy (>15hr/day) on a daily basis for chronic hypoxemia. 15. Patients with a history of asthma or onset of symptoms prior to age 40 years. 16. Patients with concomitant pulmonary disease (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, tuberculosis). 17. Patients with primary bronchiectasis. 18. Patients with a diagnosis of a-1 antitrypsin deficiency (AATD). 19. Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation. 20. Active abuse of drugs or alcohol, poor compliance anticipated. 21. 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. 22. Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study. 23. Use of other investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening visit. 24. Those unable in the opinion of the Investigator to comply fully with the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: The secondary objective of clinical part of this study is to compare the effectiveness of atorvastatin with a matched placebo control on lung function and health related quality of life changes in patients with chronic obstructive pulmonary diseases. The secondary objective of genomic part is to provide with evidence that atorvastatin exerts direct anti-inflammatory activity regulated on gene level and thus to develop atorvastatin response biomarkers for personalized treatment of COPD. ;Primary end point(s): 1. Exacerbation rate. 2. Time to exacerbation.;Timepoint(s) of evaluation of this end point: The time points of evaluation will be Follow up 6, 12, 26, 38, 52 weeks after randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Duration of exacerbation 2. Changes in forced expiratory volume in the first second (FEV1) 3. Changes in health-related quality of life (SGRQ score) 4. Changes in inflammatory pathway gene expression in the peripheral blood leukocytes (PBLs) by RNA-seq analysis 5. Changes in blood inflammatory markers (Peripheral blood leucocyte count, fibrinogen, Interleukin-6, high sensitivity C – reactive protein) Other secondary endpoints of clinical part include: 1. 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) 2. 6 minute walking distance (6MWD) and the rate of hospitalizations 3. Changes in vital signs ( blood pressure, HR), and/or laboratory findings. 4. The rate of hospitalization (pulmonary or MACE) ;Timepoint(s) of evaluation of this end point: The time points of evaluation will be Follow up 6, 12, 26, 38, 52 weeks after randomisation. | — |
Countries
Poland
Contacts
Public ContactStudy coordinator
Medical University of Bialystok
Outcome results
None listed