Clinical trial NCT03262064: Different Phenotypes of Bronchiectasis
Official title: Different Phenotypes of Bronchiectasis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bronchiectasis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: ( Severity of Bronchiectasis will be measured according to BSI scoring system and FACED scoring system
timeFrame: Baseline
Secondary outcomes:
measure: management of bronchectasis according to severity index
timeFrame: Baseline
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
name: Maha El-kholy, Prof
role: STUDY_DIRECTOR
References:
citation: Wilson CB, Jones PW, O'Leary CJ, Hansell DM, Cole PJ, Wilson R. Effect of sputum bacteriology on the quality of life of patients with bronchiectasis. Eur Respir J. 1997 Aug;10(8):1754-60. doi: 10.1183/09031936.97.10081754.
citation: Eshed I, Minski I, Katz R, Jones PW, Priel IE. Bronchiectasis: correlation of high-resolution CT findings with health-related quality of life. Clin Radiol. 2007 Feb;62(2):152-9. doi: 10.1016/j.crad.2006.08.015.
citation: Chalmers JD, Goeminne P, Aliberti S, McDonnell MJ, Lonni S, Davidson J, Poppelwell L, Salih W, Pesci A, Dupont LJ, Fardon TC, De Soyza A, Hill AT. The bronchiectasis severity index. An international derivation and validation study. Am J Respir Crit Care Med. 2014 Mar 1;189(5):576-85. doi: 10.1164/rccm.201309-1575OC.
citation: Martinez-Garcia MA, de Gracia J, Vendrell Relat M, Giron RM, Maiz Carro L, de la Rosa Carrillo D, Olveira C. Multidimensional approach to non-cystic fibrosis bronchiectasis: the FACED score. Eur Respir J. 2014 May;43(5):1357-67. doi: 10.1183/09031936.00026313. Epub 2013 Nov 14.