Different Phenotypes of Bronchiectasis

July 1, 2019 updated by: Samah Mohammad Hussein, Assiut University
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 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.

Study Overview

Detailed Description

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. 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.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 progressionIn 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.

In case of the BSI, it predicted future mortality, and in the case of FACED, extended to prediction of future exacerbation frequency, hospitalisation and quality of life.These severity scores have utility in identifying an individual's risk of disease progression to a predefined outcome and aid in sub classifying 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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Assiut, Egypt, Assiut University71515
        • Assiut university Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

all patients (age >18and <70 years old) who will be presented to Assuit Chest Department from August 2017 till August 2018 and diagnosed as bronchiectasis according to clinical picture and high- resolution computed tomography scan of the chest.

Description

Inclusion Criteria:

patient diagnosed as bronchiectasis according to clinical picture and high- resolution computed tomography scan of the chest.

can perform pulmonary function test.

Exclusion Criteria:

No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
( Severity of Bronchiectasis will be measured according to BSI scoring system and FACED scoring system
Time Frame: Baseline

BSI (Bronchiectasis severity index) score parameters include: Age, Body mass index, %FEV1 predicted, Previous Hospital admissions, Number of exacerbations in previous year, MRC dyspnea scale, Pseudomonas colonization, colonization with other organisms and radiological severity.

Scoring:

0-4 points Mild bronchiectasis 5-8points Moderate bronchiectasis 9+ points Severe bronchiectasis FACED score F - FEV1 A - Age C - Chronic colonization E - Radiological Extension D - Dyspnea

Scoring:

0-2 points Mild bronchiectasis 3-4 points Moderate bronchiectasis 5-7 points Severe bronchiectasis

Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
management of bronchectasis according to severity index
Time Frame: Baseline
we will modify treatment of bronchectasis according to different phenotypes of bronchiectasis and severity score.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Maha El-kholy, Prof

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2017

Primary Completion (ACTUAL)

September 1, 2018

Study Completion (ACTUAL)

January 1, 2019

Study Registration Dates

First Submitted

August 22, 2017

First Submitted That Met QC Criteria

August 24, 2017

First Posted (ACTUAL)

August 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 1, 2019

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • DPOB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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