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 @ 1:13 PM
Ignite Modification Date:
2025-12-24 @ 1:13 PM
NCT ID:
NCT03680495
Eligibility Criteria:
Inclusion Criteria for AECOPD with Ventilatory Failure Cohort:
* Emergency Department (ED) or ICU physician diagnosis of an acute exacerbation of COPD
* Age ≥ 40 years of age
* Need for ventilator support in the ED or ICU during the first 24 hours
Inclusion Criteria for Stable COPD Cohort:
* Physician diagnosis of COPD
* Age ≥ 40 years of age
* Frequency matched to AECOPD subjects for:
* Age (± 10 year increments)
* Current/Former smoking status (former smoker = no smoking for ≥ 1 month)
* Lung function (FEV1% predicted by ± 10% increments)
Exclusion Criteria for AECOPD with Ventilatory Failure Cohort:
* Systemic steroid use ≤ 30 days prior to return visit
* Infection requiring antibiotics ≤ 1 month prior to return visit
* Hemoglobin \< 8.0 g/dl
* Acute pulmonary embolism
* Diabetes
* History of immunodeficiency, interstitial lung disease, neuromuscular disorder or heart failure with respiratory exacerbation
* Tracheostomy
* Drugs that induce cytochrome P450 3A enzyme activity (e.g. barbiturates, phenytoin or carbamazepine) or drugs that inhibit cytochrome P450 3A activity (e.g. ketoconazole and chronic macrolide antibiotics)
* Age ≥ 90 year of age
* Known pregnancy
* Nursing mothers
* Prisoners
Exclusion Criteria for Stable COPD Cohort:
* Systemic steroid use ≤ 30 days prior to return visit
* Infection requiring antibiotics ≤ 1 month prior to return visit
* Hemoglobin \< 8.0 g/dl
* Acute pulmonary embolism
* Diabetes
* History of immunodeficiency, interstitial lung disease, neuromuscular disorder or heart failure with respiratory exacerbation
* Tracheostomy
* Drugs that induce cytochrome P450 3A enzyme activity (e.g. barbiturates, phenytoin or carbamazepine) or drugs that inhibit cytochrome P450 3A activity (e.g. ketoconazole and chronic macrolide antibiotics)
* Age ≥ 90 year of age
* Known pregnancy
* Nursing mothers
* Prisoners
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
89 Years
Study:
NCT03680495
Study Brief:
Protocol Section:
NCT03680495