Role of Bronchoscopy in Bronchiectasis
Primary Purpose
Bronchoscopy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bronchoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Bronchoscopy
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
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
NCT ID
NCT04208607
First Posted
September 21, 2019
Last Updated
December 19, 2019
Sponsor
Assiut University
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
Learn more about this trial
Role of Bronchoscopy in Bronchiectasis
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