Roflumilast in Non-CF Bronchiectasis Study

• Status: Completed
• Trial end date: 2019-08-31
• Target enrollment: 0
• Participant gender: All

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 pathological dilatation of bronchi. The predominant aetiology of bronchiectasis in the Western population is related to cystic fibrosis (CF), which is genetically determined. Bronchiectasis due to other causes are generally grouped under the term "non-CF bronchiectasis", which accounts for practically all cases that are seen commonly in Hong Kong and many other Chinese populations.

The main pathogenesis of non-CF bronchiectasis involves airway inflammation, abnormal mucus clearance and bacterial colonization, resulting in progressive airway destruction and distortion. The current treatment strategies mainly focus on targeting the key elements in the pathogenesis of non-CF bronchiectasis.

In patients with bronchiectasis, there is also neutrophilic inflammation as in COPD. It is hypothesized that roflumilast can improve airway inflammation, sputum volume and sputum inflammatory markers in patients with bronchiectasis.

This study aims to investigate the effect of short-term (4-week) treatment with roflumilast on neutrophilic airway inflammation in stable-state non-CF bronchiectasis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong

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.