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 @ 7:39 PM
Ignite Modification Date:
2025-12-24 @ 7:39 PM
NCT ID:
NCT02978703
Eligibility Criteria:
Inclusion Criteria:
* patients selected for treatment with the inhaled combination of propionic Fluticasone and Salmeterol (500+50)mcg - Rolenium- administered with Elpenhaler device
* FEV1 \<50% predicted normal (pre-bronchodilator),
* a history of repeated exacerbations who have significant symptoms despite regular bronchodilator therapy treated in Hospital outpatient specialist ward settings, in the daily clinical practice
* have signed informed consent
* be compliant with study procedures
Exclusion Criteria:
* \- patients not selected for treatment with the inhaled combination of propionic
* FEV1 \>50% predicted normal (pre-bronchodilator),
* no history of repeated exacerbations
* not signed informed consent
* will not be compliant with study procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02978703
Study Brief:
Protocol Section:
NCT02978703