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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 : 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

Study Description
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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

Condition or disease Intervention/treatment Phase
Bronchiectasis Drug: Roflumilast Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
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
Official Title: Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup
Drug Information available for: Roflumilast

Arms and Interventions
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Arm Intervention/treatment
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.

 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)


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090294


Contacts
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Contact: Maha Ahmed Okasha, Resident 01002660421 maha.ahmed201388@gmail.com
Contact: Ahmad Shaddad, Lecturer 00201111171930 shaddad_ahmad@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Ahmad Shaddad, Lecturer Assuit University - Assuit - Egypt
More Information
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Additional Information:
2. King PT, Holdsworth SR, Freezer NJ, Villanueva E, Holmes PW. Characterisation of the onset and presenting clinical features of adult bronchiectasis. Respir Med. 2006;100:2183-2189. [PubMed] [Google Scholar]  This link exits the ClinicalTrials.gov site The preclinical pharmacology of roflumilast--a selective, oral phosphodiesterase 4 inhibitor in development for chronic obstructive pulmonary disease.Pulm Pharmacol Ther 2010;23:235-56. 10.1016/j.pupt.201  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Maha Ahmed Abd El-Gawad Mohamed Okash, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04090294    
Other Study ID Numbers: Roflumilast in bronchiectasis
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: the investigator group is welling to share all Data after finishing the study
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 24 Months
Access Criteria: open Access

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases