Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis

• Status: Unknown status
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Aim of the work

Assessment of early outcome of using Roflumilast in patients with bronchiectasis regarding:

• Severity of symptoms

• Frequency of exacerbations

• Change in pulmonary function

• Systemic inflammation

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assiut University

Criteria

Inclusion Criteria:

• Aged 18 years or above, male or female.

• Non / Ex-smokers.

• Confirmed diagnosis of bronchiectasis based on high-resolution computed tomography scan.

• Significant sputum production (≥ 10 ml per day).

Exclusion Criteria:

• Non-stable patients who need ICU admission /mechanical ventilation.

• Active smokers.

• Moderate to severe liver impairment (Child-Pugh B or C) and/or sever renal impairment (c. clearance less than 30ml/min).

• Known psychiatric illness

• Concomitant use of strong cytochrome P450 inducers (e.g. rifampicin)

• Patients who are hypersensitive to roflumilast.

• Pregnant or lactating women