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 @ 9:36 PM
Ignite Modification Date:
2025-12-24 @ 9:36 PM
NCT ID:
NCT03935932
Eligibility Criteria:
Inclusion Criteria:
1. Male or Female 40 to 85 years old
2. Diagnosis of chronic bronchitis
3. Able to regularly produce sputum
4. Clinically stable
5. Current smoker or ex-smoker with a tobacco history of ≥10 pack-years (1 pack year = 20 cigarettes smoked per day for 1 year)
6. History of moderate to very severe COPD with a post-bronchodilator FEV1/FVC\<0.70 and a post-bronchodilator FEV1\>20% and ≤70% of predicted normal value at enrollment.
7. CAT score ≥ 10, with questions 1 and 2 responses ≥ 5
Exclusion Criteria:
1. Pregnant or nursing or unwilling to perform pregnancy testing
2. Unwilling or unable to refrain for SABA/LABA use ahead of the study
3. Unable to lie recumbent for 90 min,
4. Clinically important pulmonary disease other than COPD (e.g. active lung infection, clinically significant bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency and primary ciliary dyskinesia) or another diagnosed pulmonary or systemic disease that is associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hyper-eosinophilic syndrome) and/ or radiological findings suggestive of a respiratory disease other than COPD that is contributing to the subject's respiratory symptoms.
5. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and/or could:
* Affect the safety of the subject throughout the study
* Influence the findings of the study or their interpretation
* Impede the subject's ability to complete the entire duration of study
6. Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 2 weeks prior to enrollment, based on last dose of steroids or last date of hospitalization whatever occurred later
7. Acute upper or lower respiratory infection within 2 weeks prior to enrollment
8. Supplemental oxygen use at greater than 3 liters/min
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT03935932
Study Brief:
Protocol Section:
NCT03935932