Brief Title
Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis
Official Title
Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis
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 - Systemic inflammation
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 manifestation is a productive cough. Bronchiectasis is currently nearly always diagnosed using high-resolution computed tomography (HRCT) scanning. The main diagnostic features are: 1) internal diameter of a bronchus is wider than its adjacent pulmonary artery; 2) failure of the bronchi to taper; and 3) visualization of bronchi in the outer 1-2 cm of the lung fields. - From a series of benzamide derivatives, roflumilast (3-cyclo-propylmethoxy-4-difluoromethoxy-N-[3,5-di-chloropyrid-4-yl]-benzamide) was identified as a potent and selective PDE4 inhibitor. It inhibits PDE4 activity from human neutrophils. PDE4 inhibitors were demonstrated to inhibit inflammatory cytokine and mediator release from inflammatory cells. In addition, it inhibits neutrophil chemotaxis or migratory activity. Lastly, PDE4 inhibitor promotes apoptosis of these cells . - Studies have demonstrated the efficacy of roflumilast in patients with both asthma and COPD, where roflumilast improved lung function and reduced exacerbation rates. - Bronchiectasis is a chronic destructive lung disease, which is characterised by persistent bacterial colonization, bronchial inflammation, reduced mucociliaryclearance, and in some patients progressive tissue damage. There is evidence of an associated influx of neutrophils into the lungs of these patients , resulting in the expectoration of large volumes of purulent sputum containing neutrophils and their products, so In patients with bronchiectasis, there is also neutrophilic inflammation as in COPD. - The PDE4 inhibitor, roflumilast, was evaluated in short term clinical trial of non-cystic fibrosis bronchiectasis. It has been shown symptomatic improvement from baseline Park J. found that 16 weeks Roflumilast treatment in patients with non cystic fibrosis bronchiectasis significantly reduce CAT score and improve the symptoms of non-CF bronchiectasis.
Study Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Assessment of efficacy of Roflumlilast regarding control of patients with non cystic fibrosis bronchiectasis
Condition
Bronchiectasis
Intervention
Roflumilast
Study Arms / Comparison Groups
Roflumilast -non roflumilast
Description: 35 patients will receive Roflumilast for three months and improvement regarding dyspnea scales , Pulmonary function Test , Six minutes walking test and bronchectasis severity index (FACED) score pre and post therapy will be assessed. patients will receive Roflumilast 500 Mcg. Tablet Once daily for Three months and then base line assessment will be repeated to evaluate improvement.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
35
Start Date
October 1, 2019
Completion Date
November 2020
Primary Completion Date
September 2020
Eligibility 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
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Ahmad Shaddad, Lecturer, 01002660421, [email protected]
Administrative Informations
NCT ID
NCT04090294
Organization ID
Roflumilast in bronchiectasis
Responsible Party
Principal Investigator
Study Sponsor
Assiut University
Study Sponsor
Ahmad Shaddad, Lecturer, Principal Investigator, Assuit University - Assuit - Egypt
Verification Date
September 2019