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:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT03554460
Eligibility Criteria:
Inclusion Criteria:
* presented clinically stable (no exacerbation in the 4 weeks prior to study
* participation or with no change in medications);
* physician diagnosed COPD, forced expiratory volume in 1s (FEV1) \< 50% predicted; dyspnea as a main symptom that limited daily activities.
Exclusion Criteria:
* subjects with obvious pulmonary bullae demonstrated by chest CT scan or X-ray; examination or facial trauma/malformation, recent facial, upper airway or upper gastrointestinal tract surgery, that would preclude receiving NIV therapy;
* a history of coronary artery disease or cardiac arrhythmias or potential electrocardiographic alterations;
* a history of uncontrolled hypertension, or other respiratory diseases;
* patients with musculoskeletal or neurological disorders;
* failure to comply with the research protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT03554460
Study Brief:
Protocol Section:
NCT03554460