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

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 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]

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