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 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT04107493
Eligibility Criteria:
Inclusion Criteria:
1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
2. Male or female, age ≥ 18 years at the time of signing informed consent.
3. Diagnosed with COPD and currently in a stable state (at least 4 weeks since last exacerbation episode22).
4. Current prescription for long-term oxygen therapy.
5. Participants meet the criteria for pulse-dose portable oxygen delivery, defined as being mobile within the home and the qualifying blood gas study was performed at rest/ awake or during exercise.
6. Participants who can read and comprehend English.
Exclusion Criteria:
1. Clinically unstable, in the investigator's opinion, which might jeopardize the participant's safety or compliance with the protocol.
2. Current oxygen therapy prescription for \>5 L/min continuous flow.
3. Known or suspected contraindication for pulse-dose oxygen.
4. Unable to complete 6MWTs, e.g., unstable angina and myocardial infarction during the previous month
5. Female who is pregnant, breast-feeding, or intends to become pregnant, or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04107493
Study Brief:
Protocol Section:
NCT04107493