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 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT04990869
Eligibility Criteria:
Inclusion Criteria COPD patients:
1. Written informed consent.
2. Age 60 or older.
3. A body mass index (BMI) between 18.5-40.0 kg·m-2 and a weight ≥ 40 kg at enrolment.
4. A diagnosis of chronic obstructive pulmonary disease (FEV1/FVC \< 0.7).
5. Smoking history of at least 10 pack years, but currently ex-smoker.
6. Not using any inhalation steroids.
7. A worsening of symptoms in relation to respiratory infections.
8. Eosinophil count \< 0.3 at inclusion or within 3 months.
Exclusion Criteria COPD patients:
1. Exacerbation of COPD or severe airway infection within the last two months.
2. Chronic use of supplements containing vitamin B or NR.
3. Planned surgery during the course of the trial.
4. Dementia/cognitive impairment or symptomatic psychiatric illness.
5. Cancer diagnosis within last 5 years.
6. Inability to speak and read Danish.
7. Unwillingness or inability to follow the procedures outlined in the protocol.
8. Concurrent enrollment in another clinical study involving an investigational treatment.
Inclusion Criteria Controls:
1. Written informed consent.
2. Age-, sex- and BMI-matched with COPD patients.
3. No history of lung disease.
4. Never-smoker.
Exclusion Criteria Controls:
1. Chronic use of supplements containing vitamin B or NR.
2. Planned surgery during the course of the trial.
3. Dementia/cognitive impairment or symptomatic psychiatric illness.
4. Cancer diagnosis within last 5 years.
5. Inability to speak and read Danish.
6. Unwillingness or inability to follow the procedures outlined in the protocol.
7. Concurrent enrollment in another clinical study involving an investigational treatment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT04990869
Study Brief:
Protocol Section:
NCT04990869