Different Phenotypes of Bronchiectasis

Sponsor
Assiut University (Other)
Overall Status
Terminated
CT.gov ID
NCT03262064
Collaborator
(none)
100
1
18
5.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Pulmonary function tests,Bronchiectasis severity index score

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 Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Different Phenotypes of Bronchiectasis
Actual Study Start Date :
Jul 1, 2017
Actual Primary Completion Date :
Sep 1, 2018
Actual Study Completion Date :
Jan 1, 2019

Outcome Measures

Primary Outcome Measures

  1. ( Severity of Bronchiectasis will be measured according to BSI scoring system and FACED scoring system [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

Secondary Outcome Measures

  1. management of bronchectasis according to severity index [Baseline]

    we will modify treatment of bronchectasis according to different phenotypes of bronchiectasis and severity score.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut University Hospital Assiut Egypt Assiut University71515

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Maha El-kholy, Prof,

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Samah Mohammad Hussein, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT03262064
Other Study ID Numbers:
  • DPOB
First Posted:
Aug 25, 2017
Last Update Posted:
Jul 5, 2019
Last Verified:
Sep 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 5, 2019