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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT05286918
Eligibility Criteria:
Inclusion Criteria:
1. Being diagnosed with active AECOPD (AECOPD is defined as an event in the natural course of a disease characterized by a change in baseline dyspnoea, cough, and/or sputum that is beyond the normal day-to-day variations with acute onset, which may warrant a change in regular medication in patients with underlying COPD).
2. Known COPD in their medical records.
3. Age 40 years or older.
4. Able to provide informed consent in Cantonese, Mandarin, or English
5. Able to complete the questionnaires during the study period (i.e. 6 months after randomisation)
Exclusion Criteria:
Patients will be excluded if any ONE of the following are present:
1. Pre-treatment with systemic corticosteroids for the present exacerbation.
2. Pre-treatment with any antibiotics for the present exacerbation, any concurrent infection or prophylaxis.
3. Known clinical stroke in past 6 months
4. Patients with high suspicion of active AECOPD mimics:
1. Pneumonia
2. Congestive heart failure
3. Bronchiectasis
4. Pulmonary embolism
5. Pneumothorax
6. Atrial fibrillation / flutter
5. Lung comorbidities:
1. Cystic fibrosis
2. Tuberculosis
3. Unresolved lung malignancy
6. Progression or new radiographic abnormalities on the chest X-ray.
7. Immunodeficiency disorders such as AIDS, humoral immune defect, ciliary dysfunction etc., and the use of immunosuppressive drugs for more than 28 days.
8. Active inflammatory condition (e.g. flare up of rheumatoid arthritis, gout or polymyalgia rheumatica) or concurrent infection at another site (e.g. UTI, cellulitis) that is likely to produce a systemic response
9. Currently pregnant
10. NEWS2 score of ≥3
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT05286918
Study Brief:
Protocol Section:
NCT05286918