Status:
COMPLETED
Roflumilast in Non-CF Bronchiectasis Study (2019)
Lead Sponsor:
The University of Hong Kong
Conditions:
Non-cystic Fibrosis Bronchiectasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a single-arm, open label, Phase II study of 12-week use of Roflumilast in stable-state non-cystic fibrosis bronchiectasis subjects. Bronchiectasis refers to a suppurative lung condition chara...
Detailed Description
In a 4-week crossover study in 38 patients with COPD, roflumilast 500μg daily significantly reduced sputum absolute neutrophil count, IL-8 and neutrophil elastase compared with placebo treatment. Inte...
Eligibility Criteria
Inclusion
- Aged 18 years or above, male or female.
- Never-smokers or those who have smoked less than 100 cigarettes in their lifetime.
- Confirmed diagnosis of non-CF bronchiectasis based on high-resolution computed tomography (HRCT) scan.
- Significant sputum production (≥ 10 ml per day).
- In stable-state bronchiectasis with no change in regular medications (e.g. inhaled steroid, macrolide) or exacerbations in the past 3 months.
- Written informed consent obtained.
Exclusion
- Eversmokers (≥ 100 cigarettes in their lifetime).
- Known chronic obstructive pulmonary disease or asthma.
- Moderate to severe liver impairment (Child-Pugh B or C).
- Known psychiatric illness with increased suicidal risks.
- Body-mass index below 18 kg/m2.
- Concomitant use of strong cytochrome P450 inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin).
- Patients who are hypersensitive to roflumilast or its constituents.
- Pregnant or lactating women.
Key Trial Info
Start Date :
November 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04322929
Start Date
November 12 2020
End Date
November 30 2024
Last Update
December 9 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Queen Mary Hospital
Hong Kong, Hong Kong