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Search / Trial NCT03428334

Roflumilast in Non-CF Bronchiectasis Study

Launched by THE UNIVERSITY OF HONG KONG · Feb 8, 2018

Trial Information

Current as of May 02, 2025

Completed

Keywords

Sputum Leukocyte Density

ClinConnect Summary

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 load in destroyed airways, thus controlling and preventing infective exacerbations. In recent years, accumulated evidence has suggested a central role of airway inflammation and immune dysregulation in the evolution of non-CF bronchiectasis. The classical type of airway inflammation is neutrophilic, with abundance of neutrophils in sputum, bronchoalveolar lavage fluid and bronchial biopsy from pat...

Gender

ALL

Eligibility 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.

About The University Of Hong Kong

The University of Hong Kong (HKU) is a leading research institution dedicated to advancing medical knowledge and improving healthcare outcomes through innovative clinical trials. With a commitment to excellence in research and education, HKU collaborates with various stakeholders, including healthcare providers and industry partners, to conduct rigorous and ethically sound clinical studies. The university's diverse expertise and state-of-the-art facilities enable it to explore a wide range of therapeutic areas, contributing to the global pursuit of scientific advancement and the development of novel treatment strategies.

Locations

Hong Kong, , Hong Kong

Patients applied

0 patients applied

Trial Officials

James CM Ho, MD

Principal Investigator

The University of Hong Kong

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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