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Role of Bronchoscopy in Bronchiectasis

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ClinicalTrials.gov Identifier: NCT04208607
Recruitment Status : Not yet recruiting
First Posted : December 23, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Esraa Yassin Ibrahim, Assiut University

Brief Summary:
Role of bronchoscopy in diagnosis of bronchiectasis in to different types

Condition or disease Intervention/treatment Phase
Bronchoscopy Procedure: Bronchoscopy Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Bronchiectasis Phenotypes ; Clinical , Radiological and Microbiological Assesment
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Study group
Patients with bronchiectasis
Procedure: Bronchoscopy
Role of bronchoscopy in diagnosis of bronchiectasis




Primary Outcome Measures :
  1. Percentage of bronchiectatic patients with pseudomonal infection [ Time Frame: One week ]
    Bronchoscopy will be done to all patients and bronchoalveolar lavage will be taken



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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Responsible Party: Esraa Yassin Ibrahim, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04208607    
Other Study ID Numbers: Bronchoscopy in bronchiectasis
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019

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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