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 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT03432234
Eligibility Criteria:
Inclusion Criteria:
* Spirometry: FEV1/FVC \< 70%; FEV1 between 50 and 80% predicted (GOLD II/III)
* Clinical Stability (no therapeutic change and/or use of antibiotics) during 8 weeks. - The treatment received will be registered for post-hoc studies stratified by this condition.
Exclusion Criteria:
* Drug addiction, alcohol abuse,
* Use of long-term oral or nebulised antibiotic therapy.
* History of allergies, asthma or other chronic respiratory disease, sanitary worker, working exposure to dust or fumes.
* Other diseases: Severe cardiovascular, neurological, psychiatric, renal, hepatic or gastrointestinal , that might interfere with the daily life activities.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT03432234
Study Brief:
Protocol Section:
NCT03432234