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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT01381367
Eligibility Criteria:
Inclusion Criteria:
1. no previously vaccination with PPSV23,
2. a clinical diagnosis of severe COPD which is defined according to the GOLD 2006 guideline (11): FEV1/FVC \< 70%, FEV1 reversibility test \< 200 ml, and FEV1 \< 50% of predicted,
3. current or past exposure of smoking,
4. no exacerbation in the month prior to enrollment,
5. age \< 65 years,
6. using high daily dose of ICS (budesonide \> 800-1600 mcg/day or fluticasone \> 500-1000 mcg/day),
7. providing written informed consent.
Exclusion Criteria:
1. Patients are excluded from the study if they are pregnant, or have immunosuppressed status (known current neoplasm, renal insufficiency in dialysis, human immunodeficiency virus (HIV) infection, severe hepatic impairment, hypogammaglobulinemia, anatomical or functional asplenia).
2. Asthma, cystic fibrosis, bronchiectasis, and severe sequelae of pulmonary tuberculosis are also excluded by pulmonary function study and chest imaging before patient's enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01381367
Study Brief:
Protocol Section:
NCT01381367