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 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT03428334
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18 years or above, male or female.
2. Never-smokers or those who have smoked less than 100 cigarettes in their lifetime.
3. Confirmed diagnosis of non-CF bronchiectasis based on high-resolution computed tomography (HRCT) scan.
4. Significant sputum production (≥ 10 ml per day).
5. In stable-state bronchiectasis with no change in regular medications (e.g. inhaled steroid, macrolide) or exacerbations in the past 3 months.
6. Written informed consent obtained.
Exclusion Criteria:
1. Eversmokers (≥ 100 cigarettes in their lifetime).
2. Known chronic obstructive pulmonary disease or asthma.
3. Moderate to severe liver impairment (Child-Pugh B or C).
4. Known psychiatric illness with increased suicidal risks.
5. Body-mass index below 20 kg/m2.
6. Concomitant use of strong cytochrome P450 inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin).
7. Patients who are hypersensitive to roflumilast or its constituents.
8. Pregnant or lactating women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03428334
Study Brief:
Protocol Section:
NCT03428334