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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07363694
Eligibility Criteria:
Key Inclusion Criteria:
* Diagnosis of chronic obstructive pulmonary disease (COPD) for at least 12 months (based on Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] definition).
* Spirometry values (post-bronchodilator forced expiratory volume in 1 second \[FEV1\]/forced vital capacity \[FVC\] less than \[\<\] 70 percent (%) and post-bronchodilator FEV1 % predicted \<70%, but greater than equal to 30%).
* Continuous treatment with standard of care triple therapy of LABA + LAMA + ICS for ≥ 6 months prior to Screening Visit 1 and at a stable dose for ≥3 months
* Documented history of at least 2 moderate or severe ECOPD within the last 12 months prior to Screening.
Key Exclusion Criteria:
* Significant pulmonary disease other than COPD.
* Requirement for continuous chronic treatment with oxygen at \>4.0 liters / minute by nasal cannula or equivalent.
* Hypoxemia with a resting SpO2 \<88% while breathing ambient air (or on the participant's usual level of oxygen supplementation).
* Clinically significant cardiovascular disease, acute and/or severe left heart failure, or heart failure partial ejection fraction, and/or cor pulmonale.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
80 Years
Study:
NCT07363694
Study Brief:
Protocol Section:
NCT07363694