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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT04961060
Eligibility Criteria:
Inclusion Criteria:
1. COPD patient admitted to the hospital for an acute exacerbation of COPD
2. Physician diagnosed COPD according to the GOLD 2020 guidelines, including symptoms consistent with COPD, post-bronchodilator FEV1 \< 80% predicted and FEV1/FVC \< 70%.
3. Age \> 40 years.
4. Smoker or ex-smoker, ≥ 10 pack years of smoking.
Exclusion Criteria:
1. Current asthma, or prior physician diagnosis of asthma without a symptom- free interval of at least 10 years before the age of 40.
2. Chronic use of prednisolone.
3. Use of systemic corticosteroids ≥4 days prior to hospital admission.
4. Necessity (upon hospitalization) for non-invasive ventilation or ICU admission.
5. Pneumonia at presentation documented by chest roentgenography.
6. Any other clinically relevant lung disease deemed to interfere with the concept of the study design.
7. Allergy to systemic corticosteroids or to antibiotics.
8. Females of childbearing potential without an efficient contraception unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH \>40 mIU/mL or the use of one or more of the following acceptable methods of contraception:
1. Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy).
2. Hormonal contraception (implantable, patch, oral, injectable).
3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository.
4. Continuous abstinence
9. Pregnancy or lactation.
10. Known immunodeficiency.
11. Life expectancy less than 60 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04961060
Study Brief:
Protocol Section:
NCT04961060