Status:
COMPLETED
Roflumilast in Non-CF Bronchiectasis Study
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 Roflumilast in stable-state non-cystic fibrosis bronchiectasis subjects. Bronchiectasis refers to a suppurative lung condition characterized by pat...
Detailed Description
Apart from regular chest physiotherapy and postural drainage to help clearing mucus from bronchiectatic airways, inhalational and parenteral antibiotics have also been used to reduce the bacterial loa...
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 20 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 :
May 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03428334
Start Date
May 10 2018
End Date
August 31 2019
Last Update
October 1 2019
Active Locations (1)
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1
Queen Mary Hospital
Hong Kong, Hong Kong