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 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 12:07 AM
NCT ID:
NCT05342558
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 40 to 80 years
* Men and women (not fertile, not pregnant, or those with a effective birth control method)
* COPD diagnosis according to GOLD 2017 criteria with a FEV1 ≥ 30%
* Biomass smoke exposition index ≥ 100 hours/year or smoking index ≥ 10 packs/year,
* Patients with at least two exacerbations in the last 12 months (confirmed by the prescription of antibiotic and/or oral steroid)
* Patients with stable COPD (no exacerbations or respiratory infections in the 4 weeks prior inclusion).
Exclusion Criteria:
* Patients with allergies or intolerance to study medications
* Female patients on pregnancy, lactancy
* Patients with cancer diagnosis
* Patients with bronchiectasis, tuberculosis, recent COPD exacerbation, or any respiratory infection or cardiovascular anomaly that withholds the respiratory function test
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT05342558
Study Brief:
Protocol Section:
NCT05342558