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 @ 1:10 PM
Ignite Modification Date:
2025-12-24 @ 1:10 PM
NCT ID:
NCT04263961
Eligibility Criteria:
Inclusion for mild-moderate COPD patients (n = 100):
* Age between 45-65 years.
* GOLD classification I or II according to the Global initiative for Chronic Obstructive Lung Disease (GOLD) criteria (post bronchodilator FEV1/FVC \<0.7) \[2\].
* Cessation of smoking for ≥6 months.
* ≥5 packyears of smoking.
* Absence of asthma.
* Written informed consent.
Inclusion for healthy controls (n = 100):
* Age between 45-65 years.
* Absence of COPD according to the Global initiative for Chronic Obstructive Lung Disease (GOLD) criteria (post bronchodilator FEV1/FVC \<0.7) \[2\].
* Cessation of smoking for ≥6 months.
* ≥5 packyears of smoking.
* Absence of asthma.
* Written informed consent.
4.3 Exclusion criteria
Exclusion for both mild-moderate COPD patients and healthy controls:
* Subjects must be able to adhere to the study visit schedule and other protocol requirements.
* Presence of acute infections (such as hepatitis, pneumonia, pyelonephritis) in the previous 3 months.
* Signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
* Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
* Known recent substance abuse.
* Females of childbearing potential without an efficient contraception.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
65 Years
Study:
NCT04263961
Study Brief:
Protocol Section:
NCT04263961