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 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT06252805
Eligibility Criteria:
Inclusion Criteria:
* Informed consent: a signed and dated written informed consent prior to study participation
* Age: Subjects 35 years of age or order at visit 1.
* Severe COPD diagnosis: an established severe COPD defined by spirometry values:
* A post-albuterol/salbutamol FEV1/FVC ratio of \<0.70 at visit 1. FEV1: forced expiratory volume at one second FVC: forced vital capacity.
* A post-bronchodilator FEV1 \< 50% predicted normal
* Smoking history: ≥ 10 pack-years at visit 1
* Stable phase of the disease (not less than 4 weeks of stability prior visit 1)
Exclusion Criteria:
* Subjects not giving written informed consent.
* Subjects at risk of non-compliance, or unable to comply with the scheduled visits.
* Subjects affected mainly by another severe chronic respiratory disease that justifies the ventilatory alteration, for example pulmonary fibrosis or severe bronchiectasis
* Subjects with carcinoma that has not been in complete remission for at least 5 years.
* Subjects with α1-antitrypsin deficiency as the underlying cause of COPD
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Study:
NCT06252805
Study Brief:
Protocol Section:
NCT06252805