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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT03425760
Eligibility Criteria:
Inclusion Criteria:
* Patients eligible for inclusion have to fulfill all of the following criteria:
1. Stable GOLD C or D COPD patient under maintenance treatment, over 45 years, who provided signed informed consent;
2. COPD diagnosis documented by spirometry performed in the past 12 months with an FEV1/FVC \< 0.7 and an FEV1 \< 50% predicted.
Exclusion Criteria:
Patients are not eligible for inclusion if they meet one of the following criteria:
1. Patient with an ongoing COPD exacerbation\*;
2. Patient who has experienced an exacerbation\* in the previous 3 months;
3. History of asthma, allergic rhinitis, lung cancer or any other significant respiratory disease, such as tuberculosis, lung fibrosis or sarcoidosis;
4. Inability to understand the study related questions;
5. Mentally disabled patient or unable to read and write;
6. Pregnant.
7. Current participation in a clinical trial;
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03425760
Study Brief:
Protocol Section:
NCT03425760