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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT04880551
Eligibility Criteria:
Inclusion Criteria:
1. Age 30 - 85 years at Visit 1 and willing to give informed consent to participate, signed or electronic.
2. A female is eligible to enter and participate in the study if she is of:
1. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal)
2. Childbearing potential has a negative serum pregnancy test at Visit 1, and agrees to an acceptable method of contraception considered appropriate by patient's primary care provider.
3. COPD Diagnosis: Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) \[Celli, 2004\]: Progressive airflow limitation associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking.
4. Tobacco Use: Current or former smokers with a history of at least 10 pack-years of cigarette smoking. \[Number of pack-years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years represent 10 pack-years)\].
5. COPD Severity: Subjects with an established clinical history of COPD and severity defined as: FEV1/FVC ratio must be \<0.70 and FEV1 between 40-80% of predicted normal value calculated using NHANES III reference equations.
6. Clinical data reviewed by the investigator does not suggest any harm to the patient from study enrollment.
7. Chest x-ray or computed tomography (CT) scan of the chest/lungs if available do not have clinically significant abnormalities not believed to be due to the presence of COPD
8. Compliance: Subjects must be willing to remain at the study center as required per protocol to complete all visit assessments.
Exclusion Criteria:
1. Women who are pregnant or lactating or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
2. Respiratory:
1. Asthma: Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
2. Alpha-1 Antitrypsin Deficiency: Subjects who have alpha-1 antitrypsin deficiency as the cause of COPD.
3. Other Respiratory Disorders: Subjects who have other active pulmonary disease such as active tuberculosis, lung cancer, significant bronchiectasis (high resolution CT evidence of bronchiectasis that causes repeated acute exacerbations), sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea (i.e., in the opinion of the Investigator severity of the disorder would impact the conduct of the study). Note: Allergic rhinitis is not exclusionary.
4. Lung Volume Reduction: Subjects who have undergone lung volume reduction surgery, lobectomy or bronchoscopic lung volume reduction (endobronchial blockers, airway bypass, endobronchial valves, thermal vapor ablation, biological sealants, and airway implants) within 6 months of Visit 1.
5. Hospitalization or acute COPD worsening: Subjects who have been hospitalized due to poorly controlled COPD within 2 weeks prior to Visit 1 (Screening)
6. Chest x-ray (frontal and lateral) with suspicion of pneumonia or other condition/abnormality that will require additional investigation/treatment or put the subject at risk because of participation in the study.
3. Spirometry Performance:
1. Acceptability: Subjects who cannot perform acceptable spirometry (i.e., meet ATS/ERS acceptability criteria)
2. Repeatability: Subjects who cannot perform technically acceptable spirometry with at least 3 acceptable flow-volume curves with 2 or more meeting ATS repeatability criteria for FEV1 during at least 1 of the pre-bronchodilator assessments
3. Subjects who are medically unable to withhold their short-acting bronchodilators for the six hour period prior to spirometry testing.
4. Oxygen / non-invasive positive pressure ventilation device: Subjects receiving long-term-oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 15 hours a day or using non-invasive positive pressure ventilation device. Note: Subjects using continuous positive airway pressure or bi-level positive airway pressure for Sleep Apnea Syndrome are allowed in the study if not used for ventilatory support.
5. Cardiac disease:
1. Subjects who have unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 6 months of enrollment.
2. Subjects with a recent history of acute coronary syndrome, or who have undergone percutaneous coronary intervention or coronary artery bypass graft within the past 3 months are to be excluded.
3. Subjects with congestive heart failure (CHF NYHA Class III/IV).
4. Clinically significant abnormal ECG with conduction abnormality or arrhythmia considered significant by principal investigator.
6. Investigational drugs or devices: treatment with investigational study drug or device in another clinical study within four weeks of study enrollment.
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
85 Years
Study:
NCT04880551
Study Brief:
Protocol Section:
NCT04880551