Roflumilast in Non-CF Bronchiectasis Study

NCT03428334 | Completed Phase 2

• 1 other identifier: ROF2017_v1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Non-cystic Fibrosis Bronchiectasis

Keywords

Sputum leukocyte density

Outcome Measures

Primary Outcomes (1)

• sputum leukocyte density

  Sputum leukocyte density is measured within 2 hours of collection by a designated technician, based on five aliquots chosen randomly from the center of a fresh specimen, which are then serially diluted with phosphate-buffered saline (PBS) and read with a light microscope and a hemocytometer

  Reduction of sputum leukocyte density in 4 weeks

Study Arms (1)

Oral roflumilast

EXPERIMENTAL

oral roflumilast 500 microgram daily for 4 weeks

Drug: Oral roflumilast

Interventions

Oral roflumilast DRUG

Roflumilast, a phosphodiesterase 4 (PDE4) inhibitor is approved worldwide (including Hong Kong) for treatment of severe chronic obstructive pulmonary disease (COPD) with frequent exacerbations. Roflumilast has been shown to have anti-inflammatory effect in patients with COPD, with significant reduction of sputum absolute neutrophil count, IL-8 and neutrophil elastase compared with placebo treatment. Roflumilast can also improve the lung function parameters in patients with COPD and reduce the rate of moderate-to-severe exacerbations.

Also known as: Daxas

Oral roflumilast

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Roflumilast

Study Officials

• James CM Ho, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 9, 2018
• Study Start: May 10, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

HK (1)