Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT04789057
Eligibility Criteria:
Inclusion Criteria:
1. 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.
2. Subject \[male or female\] is aged 40 years and older.
3. Subject is able to understand and comply with the protocol requirements and instructions and is likely to complete the study as planned.
4. 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.
5. At least two moderate/severe COPD exacerbations, or at least one leading to hospitalization or ICU admission within 12 months, preceding screening visit.
6. Current or ex-smokers who have a smoking history of at least 10 pack years.
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. Using e-cigarettes or I IQOS tobacco heating system.
5. Pregnant or nursing (lactating) women.
6. Women of child bearing potential, unless they are using effective method of contraception during dosing of study treatment.
7. Patient with a clinically significant abnormality at visit 1 in investigator opinion.
8. Patients with a clinically relevant laboratory abnormality at visit 1 in investigator opinion.
9. Patients with a history of malignancy of any organ system (including lung cancer).
10. Patients unable to perform acceptable spirometry and lung volumes procedures.
11. 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.
12. Patients who have had a respiratory tract infection within 4 weeks prior to visit1.
13. Patients requiring oxygen therapy (\>15hr/day) on a daily basis for chronic hypoxemia.
14. Patients with a history of asthma or onset of symptoms prior to age 40 years
15. Patients with concomitant pulmonary disease (e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, tuberculosis).
16. Patients with primary bronchiectasis.
17. Patients with a diagnosis of α-1 antitrypsin deficiency (AATD).
18. Patients with pulmonary lobectomy or lung volume reduction surgery or lung transplantation.
19. Active abuse of drugs or alcohol, poor compliance anticipated.
20. 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.
21. Patients participating in or planning to participate in the active phase of a supervised pulmonary rehabilitation program during the study.
22. Use of other investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening visit.
23. Those unable in the opinion of the Investigator to comply fully with the study requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
99 Years
Study:
NCT04789057
Study Brief:
Protocol Section:
NCT04789057