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 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT04638920
Eligibility Criteria:
Inclusion Criteria:
* Informed consent
* age \>= 18 years
* staged according to GOLD recommendations
* GOLD stage 2-4, GOLD ABE classification
* hospitalization due to COPD exacerbation
* subjects adherent to triple inhalational therapy (beta-2-sympathomimetics, anticholinergics, steroids)
* suitable for follow-up assessment
* \<48 hours after initiation of antibiotic therapy or systemic steroid therapy
Exclusion Criteria:
* physical or intellectual impairment precluding informed consent or protocol adherence
* known pregnancy
* congenital defects with direct impact on central metabolism e.g. amino acid metabolism defect
* uncontrolled diabetes (e.g. HbA1c \>11% or Glc \>20mmol/l)
* acute or chronic pulmonary disease other than COPD
* renal failure or renal replacement therapy (GFR \< 15 mL/min)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04638920
Study Brief:
Protocol Section:
NCT04638920