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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT02237820
Eligibility Criteria:
Inclusion criteria:
* Age \> 40 years.
* Patients with a previous diagnosis of COPD and evidence of airflow limitation (GOLD severity stage of II-IV).
* Patients with COPD exacerbation and potential indications for hospitalization as defined by the 2019 GOLD guidelines.
* Patients with a diagnosis of heart failure (NYHA grade II-IV).
Exclusion criteria:
* Patients with a severe exacerbation on enrollment, based upon arterial PH\<7.2 or PaCO2 \> 90 mmHg
* Patients who are currently participating in other studies.
* Known hypersensitivity to prednisone / dexamethasone.
* Patients who were treated with systemic corticosteroids one month prior to admission, unless prednisone dosage is 20 mg or less.
* Patients who are unable to provide an informed consent.
* Pregnant woman.
* Patients on Chronic mechanical ventilation.
Study drug treatment termination criteria:
* Hypersensitivity reaction to prednisone / dexamethasone.
* Any clinical deterioration, which at the discretion of the treating physician and/or study investigators, necessitate change of the study steroid treatment (such as, but not limited to, need to stop oral medication).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02237820
Study Brief:
Protocol Section:
NCT02237820