<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03262064</url>
  </required_header>
  <id_info>
    <org_study_id>DPOB</org_study_id>
    <nct_id>NCT03262064</nct_id>
  </id_info>
  <brief_title>Different Phenotypes of Bronchiectasis</brief_title>
  <official_title>Different Phenotypes of Bronchiectasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Bronchiectasis is defined as abnormal chronic dilatation of one or more bronchi. Patients&#xD;
      have a structural abnormality of the bronchial wall that predisposes them to bacterial&#xD;
      infection likely due to impaired mucus clearance. A vicious cycle of chest infections and&#xD;
      chronic lung inflammation can lead to further damage of the bronchial wall and spread of&#xD;
      disease to normal areas of bystander lung.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A search for an underlying cause, which may be amenable to a targeted intervention to prevent&#xD;
      ongoing damage, is essential but often fruitless, and the focus of therapy rapidly turns to&#xD;
      empiric treatments to prevent infective exacerbations and retard disease progression. The&#xD;
      British Thoracic Society Bronchiectasis management guidelines provide an in-depth summary of&#xD;
      the available literature and are an excellent tool for guiding treatment decision making.&#xD;
      However, they do not provide guidance on which patients are most likely to benefit from&#xD;
      specific interventions.Disease severity in bronchiectasis is hard to define. Radiological&#xD;
      severity grading scores exist; however, there is often a disconnect between radiological&#xD;
      severity, symptom burden and disease progressionIn 2014, competing bronchiectasis severity&#xD;
      scores were published (FACED and the Bronchiectasis Severity Index (BSI).&#xD;
&#xD;
      In each of these, a combination of patient demographics, symptom scores, comorbidities, and&#xD;
      clinical, radiological and microbiological parameters were used to construct scoring systems.&#xD;
&#xD;
      In case of the BSI, it predicted future mortality, and in the case of FACED, extended to&#xD;
      prediction of future exacerbation frequency, hospitalisation and quality of life.These&#xD;
      severity scores have utility in identifying an individual's risk of disease progression to a&#xD;
      predefined outcome and aid in sub classifying this heterogeneous group of patients in a&#xD;
      manner that may pave the way to future mechanistic studies, which explain how these different&#xD;
      disease phenotypes arise and inform the development of targeted therapeutics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Changing of specialty&#xD;
  </why_stopped>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">September 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>( Severity of Bronchiectasis will be measured according to BSI scoring system and FACED scoring system</measure>
    <time_frame>Baseline</time_frame>
    <description>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.&#xD;
Scoring:&#xD;
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&#xD;
Scoring:&#xD;
0-2 points Mild bronchiectasis 3-4 points Moderate bronchiectasis 5-7 points Severe bronchiectasis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>management of bronchectasis according to severity index</measure>
    <time_frame>Baseline</time_frame>
    <description>we will modify treatment of bronchectasis according to different phenotypes of bronchiectasis and severity score.</description>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Bronchiectasis</condition>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Pulmonary function tests,Bronchiectasis severity index score</intervention_name>
    <description>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.&#xD;
Radiology: All patients will have a chest radiograph (PA and lateral) and high-resolution computed tomography (HRCT) scan.&#xD;
Bronchiectasis severity index score parameters FACED Score</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        all patients (age &gt;18and &lt;70 years old) who will be presented to Assuit Chest Department&#xD;
        from August 2017 till August 2018 and diagnosed as bronchiectasis according to clinical&#xD;
        picture and high- resolution computed tomography scan of the chest.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        patient diagnosed as bronchiectasis according to clinical picture and high- resolution&#xD;
        computed tomography scan of the chest.&#xD;
&#xD;
        can perform pulmonary function test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        No&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maha El-kholy, Prof</last_name>
    <role>Study Director</role>
  </overall_official>
  <location>
    <facility>
      <name>Assiut University Hospital</name>
      <address>
        <city>Assiut</city>
        <zip>Assiut University71515</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <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>
    <PMID>9272915</PMID>
  </reference>
  <reference>
    <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>
    <PMID>17207698</PMID>
  </reference>
  <reference>
    <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>
    <PMID>24328736</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24232697</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>July 1, 2019</last_update_submitted>
  <last_update_submitted_qc>July 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Samah Mohammad Hussein</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchiectasis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03262064
org study id: DPOB
nct id: NCT03262064
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: ( Severity of Bronchiectasis will be measured according to BSI scoring system and FACED scoring system
time frame: Baseline
description: 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
measure: management of bronchectasis according to severity index
time frame: Baseline
description: we will modify treatment of bronchectasis according to different phenotypes of bronchiectasis and severity score.
intervention type: Combination Product
intervention name: Pulmonary function tests,Bronchiectasis severity index score
description: 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
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maha El-kholy, Prof
role: Study Director
facility: 
country: Egypt
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.
PMID: 9272915
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.
PMID: 17207698
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.
PMID: 24328736
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.
PMID: 24232697
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Samah Mohammad Hussein
investigator title: principal investigator
mesh term: Bronchiectasis