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

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ClinicalTrials.gov Identifier: NCT04090294
Recruitment Status : Unknown
Verified September 2019 by Maha Ahmed Abd El-Gawad Mohamed Okash, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Maha Ahmed Abd El-Gawad Mohamed Okash, Assiut University

Tracking Information
First Submitted Date  ICMJE August 21, 2019
First Posted Date  ICMJE September 16, 2019
Last Update Posted Date October 3, 2019
Estimated Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2019)
  • Assessment of efficacy of Roflumlilast regarding control of patients with non cystic fibrosis bronchiectasis [ Time Frame: 3months . outcomes will be evaluated after 1month and at the end of the study (3months). ]
    Assessment of efficacy of Roflumilast on severity of symptoms in patients with bronchiectasis. Frequency of Exacerbation in the three months assessment and need of hospitalization will be the main parameter for efficacy of the new treatment described as number/ 3 months
  • Assessment of efficacy of roflumlilast in change of performance in patients with non cystic fibrosis bronchiectasis [ Time Frame: 3months . outcomes will be evaluated after 1month and at the end of the study (3months). ]
    Assessment of efficacy of roflumilast on change dyspnea scale namely mMRCP evaluated at the start of the study and after 1 month and 3 months
  • Assessment of efficacy of roflumlilast on change in Pulmonary function in patients with non cystic fibrosis bronchiectasis [ Time Frame: 3months . outcomes will be evaluated after 1month and at the end of the study (3months). ]
    Assessment of efficacy of roflumilast on change in pulmonary function test in patients with bronchiectasis regarding : change in FEV1 by liter per second
  • Assessment of efficacy of roflumlilast on change of symptoms in patients with non cystic fibrosis bronchiectasis [ Time Frame: 3months . outcomes will be evaluated after 1month and at the end of the study (3months). ]
    Assessment of efficacy of roflumlilast on severity of symptoms in patients with bronchiactasis evaluated by bronchectasis severity index (FACED) score.
  • Assessment of efficancy of roflumlilast on change in systemic inflammation in patients with non cystic fibrosis bronchiectasis [ Time Frame: 3months . outcomes will be evaluated after 1 month and at the end of the study (3 months). ]
    Assessment of efficacy of roflumlilast on systemic inflammation in patients with bronchiectasis regarding CRP by mg per L
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
  • Assessment of efficacy of Roflumlilast regarding control of patients with non cystic fibrosis bronchiactasis [ Time Frame: 3months . outcomes will be evaluated after 1month and at the end of the study (3months). ]
    Assessment of efficacy of Roflumilast on severity of symptoms in patients with bronchiectasis. Frequency of Exacerbation in the three months assessment and need of hospitalization will be the main parameter for efficacy of the new treatment described as number/ 3 months
  • Assessment of efficacy of roflumlilast in change of performance in patients with non cystic fibrosis bronchiactasis [ Time Frame: 3months . outcomes will be evaluated after 1month and at the end of the study (3months). ]
    Assessment of efficacy of roflumilast on change dyspnea scale namely mMRCP evaluated at the start of the study and after 1 month and 3 months
  • Assessment of efficacy of roflumlilast on change in Pulmonary function in patients with non cystic fibrosis bronchiactasis [ Time Frame: 3months . outcomes will be evaluated after 1month and at the end of the study (3months). ]
    Assessment of efficacy of roflumilast on change in pulmonary function test in patients with bronchiactasis regarding : change in FEV1 by liter per second
  • Assessment of efficacy of roflumlilast on change of symptoms in patients with non cystic fibrosis bronchiactasis [ Time Frame: 3months . outcomes will be evaluated after 1month and at the end of the study (3months). ]
    Assessment of efficacy of roflumlilast on severity of symptoms in patients with bronchiactasis evaluated by bronchectasis severity index (FACED) score.
  • Assessment of efficancy of roflumlilast on change in systemic inflammation in patients with non cystic fibrosis bronchiactasis [ Time Frame: 3months . outcomes will be evaluated after 1 month and at the end of the study (3 months). ]
    Assessment of efficacy of roflumlilast on systemic inflammation in patients with bronchiactasis regarding CRP by mg per L
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
35 patients will receive roflumilast for three months and improvement regarding performance , frequency of exacerbation and pulmonary function test will be assessed.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bronchiectasis
Intervention  ICMJE Drug: Roflumilast

Roflumilast is a phosphodiesterase (PDE) type 4 inhibitor will be prescribed for three month for the study group. the patients will then be assessed for improvement regarding exacerbation frequency , performance and pulmonary function test.

patients will receive Roflumilast 500 Mcg. Tablet once daily for three months

Other Name: phosphodiestrase 4 inhibitor (PDE4)
Study Arms  ICMJE Experimental: Roflumilast -non roflumilast

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.

Intervention: Drug: Roflumilast
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 13, 2019)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04090294
Other Study ID Numbers  ICMJE Roflumilast in bronchiectasis
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: the investigator group is welling to share all Data after finishing the study
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: 24 Months
Access Criteria: open Access
Current Responsible Party Maha Ahmed Abd El-Gawad Mohamed Okash, Assiut University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Assiut University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ahmad Shaddad, Lecturer Assuit University - Assuit - Egypt
PRS Account Assiut University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP