Different Phenotypes of Bronchiectasis
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|ClinicalTrials.gov Identifier: NCT03262064|
Recruitment Status : Terminated (Changing of specialty)
First Posted : August 25, 2017
Last Update Posted : July 3, 2019
|Condition or disease||Intervention/treatment|
|Bronchiectasis||Combination Product: Pulmonary function tests,Bronchiectasis severity index score|
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|
|Actual Enrollment :||100 participants|
|Official Title:||Different Phenotypes of Bronchiectasis|
|Actual Study Start Date :||July 1, 2017|
|Actual Primary Completion Date :||September 1, 2018|
|Actual Study Completion Date :||January 1, 2019|
- Combination Product: Pulmonary function tests,Bronchiectasis severity index score
Pulmonary function tests: including spirometry, DLCO, and lung volumes. Sputum investigations: The following investigations will be performed on fresh sputum samples; gram stains and culture, smear and culture for mycobacteria and fungi and antibiotic sensitivity tests Bronchoscopy: Bronchoscopy with bronchoalveolar lavage will be used to obtain specimens for staining and culture to identify type of colonization.
Radiology: All patients will have a chest radiograph (PA and lateral) and high-resolution computed tomography (HRCT) scan.
Bronchiectasis severity index score parameters FACED Score
- ( 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.
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
0-2 points Mild bronchiectasis 3-4 points Moderate bronchiectasis 5-7 points Severe bronchiectasis
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03262064
|Assiut University Hospital|
|Assiut, Egypt, Assiut University71515|
|Study Director:||Maha El-kholy, Prof|