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Role of Bronchoscopy in Bronchiectasis

Primary Purpose

Bronchoscopy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bronchoscopy
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bronchoscopy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients more than 18 years
  • Patients less than 70 years
  • Patients with bronchiectasis

Exclusion Criteria:

  • patients with bronchial asthma or chronic obstructive pulmonary disease
  • patients with pneumonia
  • patients with T.B

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Study group

    Arm Description

    Patients with bronchiectasis

    Outcomes

    Primary Outcome Measures

    Percentage of bronchiectatic patients with pseudomonal infection
    Bronchoscopy will be done to all patients and bronchoalveolar lavage will be taken

    Secondary Outcome Measures

    Full Information

    First Posted
    September 21, 2019
    Last Updated
    December 19, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04208607
    Brief Title
    Role of Bronchoscopy in Bronchiectasis
    Official Title
    Bronchiectasis Phenotypes ; Clinical , Radiological and Microbiological Assesment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2019 (Anticipated)
    Primary Completion Date
    September 2020 (Anticipated)
    Study Completion Date
    December 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Role of bronchoscopy in diagnosis of bronchiectasis in to different types
    Detailed Description
    Bronchiectasis is defined as abnormal chronic dilatation of one or more bronchi. Patients have a structural abnormality of the bronchial wall that predisposes them to bacterial infection likely due to impaired mucus clearance. A self-perpetuating vicious cycle of chest infections and chronic lung inflammation can lead to further damage of the bronchial wall and spread of disease to normal areas of bystander lung.(1)( Wilson et al,1997). A search for an underlying cause, which may be amenable to a targeted intervention to prevent ongoing damage, is essential but often fruitless, and the focus of therapy rapidly turns to empiric treatments to prevent infective exacerbations and retard disease progression. (2) ( Martinez-Garcia, et al,2005 ) The British Thoracic Society bronchiectasis management guidelines provide an in-depth summary of the available literature and are an excellent tool for guiding treatment decision making. However, they do not provide guidance on which patients are most likely to benefit from specific interventions. (3) (Pasteur et al, 2010). Disease severity in bronchiectasis is hard to define. Radiological severity grading scores exist; however, there is often a disconnect between radiological severity, symptom burden and disease progression (4) (Eshed et al, 2007). In 2014, competing bronchiectasis severity scores were published (FACED and the Bronchiectasis Severity Index (BSI). In each of these, a combination of patient demographics, symptom scores, comorbidities, and clinical, radiological and microbiological parameters were used to construct scoring systems, which, in the case of the BSI, predicted future mortality, and in the case of FACED, extended to prediction of future exacerbation frequency, hospitalisation and quality of life. (5, 6) (Chalmers et al, 2014; Martinez-Garcia et al, 2014). These severity scores have utility in identifying an individual's risk of disease progression to a predefined outcome and aid in subclassifying this heterogeneous group of patients in a manner that may pave the way to future mechanistic studies, which explain how these different disease phenotypes arise and inform the development of targeted therapeutics. (7) (Aliberti et al, 2007).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bronchoscopy

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Study group
    Arm Type
    Experimental
    Arm Description
    Patients with bronchiectasis
    Intervention Type
    Procedure
    Intervention Name(s)
    Bronchoscopy
    Intervention Description
    Role of bronchoscopy in diagnosis of bronchiectasis
    Primary Outcome Measure Information:
    Title
    Percentage of bronchiectatic patients with pseudomonal infection
    Description
    Bronchoscopy will be done to all patients and bronchoalveolar lavage will be taken
    Time Frame
    One week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: patients more than 18 years Patients less than 70 years Patients with bronchiectasis Exclusion Criteria: patients with bronchial asthma or chronic obstructive pulmonary disease patients with pneumonia patients with T.B

    12. IPD Sharing Statement

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    Role of Bronchoscopy in Bronchiectasis

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