Status:
UNKNOWN
Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis
Lead Sponsor:
Assiut University
Conditions:
Bronchiectasis
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief 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 * Syste...
Detailed Description
Bronchiectasis is defined by the presence of permanent and abnormal dilation of the bronchi. This usually occurs in the context of chronic airway infection causing inflammation. The main clinical mani...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04090294
Start Date
October 1 2019
End Date
November 1 2020
Last Update
October 3 2019
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