xml: <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/NCT06040931</url>
    </required_header>
    <id_info>
      <org_study_id>M.S.21.08.1628</org_study_id>
      <nct_id>NCT06040931</nct_id>
    </id_info>
    <brief_title>Airway Inflammation, Small Airways Dysfunction, and Frequency of Exacerbations in COPD</brief_title>
    <official_title>Relationship Between Airway Inflammation, Small Airways Dysfunction, and Frequency of Acute Exacerbations in Patients With Chronic Obstructive Pulmonary Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mansoura University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Azza Tarik Eliwa</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Ahmed Elsayed Mansour</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Taha Taha Abdelgawad</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Ahmed Mohamed Fouda</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Mansoura University Hospital</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>
        Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable, and treatable disease&#xD;
        that is characterized by persistent respiratory symptoms and airflow limitation that is due&#xD;
        to airway and/or alveolar abnormalities usually caused by significant exposure to noxious&#xD;
        particles or gases Chronic Obstructive Pulmonary Disease (COPD) is a heterogenous disease of&#xD;
        the lungs that can comprise of different pathophysiological phenotypes, including emphysema,&#xD;
        chronic bronchitis, and Small Airways Disease (SAD). COPD is also associated with chronic&#xD;
        inflammation and this ongoing inflammation may result in airway remodeling and excessive&#xD;
        mucus plugging within the small airways Small airways disease (SAD) is a cardinal feature of&#xD;
        chronic obstructive pulmonary disease (COPD) first recognized in the nineteenth century. The&#xD;
        diverse histopathological features associated with SAD underpin the heterogeneous nature of&#xD;
        COPD. The small airways have been defined as &lt; 2mm diameter and arise from the 4th - 13th&#xD;
        generation of airway branching (taking trachea as 1st generation to alveoli as 23rd), but on&#xD;
        average arise by the 8th aim of this work is to study the relationship between neutrophilic&#xD;
        airway inflammation, small airways dysfunction, and frequency of acute exacerbation in stable&#xD;
        COPD patients&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable, and treatable disease&#xD;
        that is characterized by persistent respiratory symptoms and airflow limitation that is due&#xD;
        to airway and/or alveolar abnormalities usually caused by significant exposure to noxious&#xD;
        particles or gases Chronic Obstructive Pulmonary Disease (COPD) is a heterogenous disease of&#xD;
        the lungs that can comprise of different pathophysiological phenotypes, including emphysema,&#xD;
        chronic bronchitis, and Small Airways Disease (SAD). COPD is also associated with chronic&#xD;
        inflammation and this ongoing inflammation may result in airway remodeling and excessive&#xD;
        mucus plugging within the small airways Small airways disease (SAD) is a cardinal feature of&#xD;
        chronic obstructive pulmonary disease (COPD) first recognized in the nineteenth century. The&#xD;
        diverse histopathological features associated with SAD underpin the heterogeneous nature of&#xD;
        COPD. The small airways have been defined as &lt; 2mm diameter and arise from the 4th - 13th&#xD;
        generation of airway branching (taking trachea as 1st generation to alveoli as 23rd), but on&#xD;
        average arise by the 8th Small airway disease (SAD) has been recognized for many years as a&#xD;
        central feature of chronic obstructive pulmonary disease (COPD). Histopathology studies have&#xD;
        shown that the narrowing and destruction of small airways in COPD combined with inflammatory&#xD;
        cell infiltration in the submucosa increases the severity of the disease. SAD is present in&#xD;
        the early stages of COPD and becomes more widespread over time as the disease progresses to&#xD;
        more severe COPD Exacerbations are an acute worsening of symptoms resulting in additional&#xD;
        therapy and can be classified as mild, moderate, or severe, Exacerbations are associated with&#xD;
        faster lung function decline and hospital admissions During both stable periods and&#xD;
        exacerbations, there is increased neutrophilic inflammation in the airways of COPD subjects ,&#xD;
        Neutrophilic inflammation is a common feature of many airway diseases and is associated with&#xD;
        disease progression, often irrespective of the initiating cause or underlying diagnosis The&#xD;
        aim of this work is to study the relationship between neutrophilic airway inflammation, small&#xD;
        airways dysfunction, and frequency of acute exacerbation in stable COPD patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 1, 2022</start_date>
    <completion_date type="Actual">June 1, 2023</completion_date>
    <primary_completion_date type="Actual">December 1, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>prospective correlational study</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Correlation between neutrophilic airway inflammation and stable COPD patients</measure>
      <time_frame>one year</time_frame>
      <description>Concentration of neutrophilic count (cell/ml)in BAL</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Correlation between frequency of acute exacerbation and stable COPD patients</measure>
      <time_frame>One year</time_frame>
      <description>Rate of exacerbation / year</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>COPD Exacerbation Acute</condition>
    <arm_group>
      <arm_group_label>Infrequent exacerbators (IFE) group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>15 patients with infrequent exacerbation (IFE) &quot;≤1 exacerbation per year in the preceding 12 months before enrolment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Frequent exacerbators (FE) group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>15 patients with frequent exacerbation(FE) &quot;≥ 2 per year in the preceding 12 months before enrolment</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Bronchoscopy</intervention_name>
      <description>Bronchoscopy and broncho-alveolar lavage (BAL) to assess neutrophilic count in BAL as a measurement of airway inflammation</description>
      <arm_group_label>Frequent exacerbators (FE) group</arm_group_label>
      <arm_group_label>Infrequent exacerbators (IFE) group</arm_group_label>
      <other_name>body Plethysmography (RV/TLC)</other_name>
      <other_name>Spirometry &quot;pre and post bronchdilator to show poorly reversible airway obstruobstructin</other_name>
      <other_name>CT-chest (Paired Inspiratory and expiratory HRCT scan) and measuring mean lung density</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  established diagnosis of COPD according to GOLD 2021&#xD;
  &#xD;
            -  Patients should quit smoking at least 6 months before enrolment in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pulmonary diseases other than COPD e.g parenchymatous lung diseases&#xD;
  &#xD;
            -  Active smokers.&#xD;
  &#xD;
            -  Patients unfit for bronchoscopy.&#xD;
  &#xD;
            -  Immunosuppressive state and immunosuppressive therapy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mohamed AbdElmoniem, lecturer</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mansoura university Faculty of medicine</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>faculty of medicine Mansoura university</name>
        <address>
          <city>Mansoura</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mansoura University Hospital</investigator_affiliation>
      <investigator_full_name>Mohamed Abd Elmoniem Mohamed</investigator_full_name>
      <investigator_title>Assistant lecturer</investigator_title>
    </responsible_party>
    <keyword>neutrophilic airway inflammation</keyword>
    <keyword>small airways dysfunction</keyword>
    <keyword>acute exacerbation</keyword>
    <keyword>stable COPD patients</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Inflammation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06040931
  org study id: M.S.21.08.1628
  nct id: NCT06040931
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable, and treatable disease
        that is characterized by persistent respiratory symptoms and airflow limitation that is due
        to airway and/or alveolar abnormalities usually caused by significant exposure to noxious
        particles or gases Chronic Obstructive Pulmonary Disease (COPD) is a heterogenous disease of
        the lungs that can comprise of different pathophysiological phenotypes, including emphysema,
        chronic bronchitis, and Small Airways Disease (SAD). COPD is also associated with chronic
        inflammation and this ongoing inflammation may result in airway remodeling and excessive
        mucus plugging within the small airways Small airways disease (SAD) is a cardinal feature of
        chronic obstructive pulmonary disease (COPD) first recognized in the nineteenth century. The
        diverse histopathological features associated with SAD underpin the heterogeneous nature of
        COPD. The small airways have been defined as < 2mm diameter and arise from the 4th - 13th
        generation of airway branching (taking trachea as 1st generation to alveoli as 23rd), but on
        average arise by the 8th aim of this work is to study the relationship between neutrophilic
        airway inflammation, small airways dysfunction, and frequency of acute exacerbation in stable
        COPD patients
  Chronic Obstructive Pulmonary Disease (COPD) is a common, preventable, and treatable disease
        that is characterized by persistent respiratory symptoms and airflow limitation that is due
        to airway and/or alveolar abnormalities usually caused by significant exposure to noxious
        particles or gases Chronic Obstructive Pulmonary Disease (COPD) is a heterogenous disease of
        the lungs that can comprise of different pathophysiological phenotypes, including emphysema,
        chronic bronchitis, and Small Airways Disease (SAD). COPD is also associated with chronic
        inflammation and this ongoing inflammation may result in airway remodeling and excessive
        mucus plugging within the small airways Small airways disease (SAD) is a cardinal feature of
        chronic obstructive pulmonary disease (COPD) first recognized in the nineteenth century. The
        diverse histopathological features associated with SAD underpin the heterogeneous nature of
        COPD. The small airways have been defined as < 2mm diameter and arise from the 4th - 13th
        generation of airway branching (taking trachea as 1st generation to alveoli as 23rd), but on
        average arise by the 8th Small airway disease (SAD) has been recognized for many years as a
        central feature of chronic obstructive pulmonary disease (COPD). Histopathology studies have
        shown that the narrowing and destruction of small airways in COPD combined with inflammatory
        cell infiltration in the submucosa increases the severity of the disease. SAD is present in
        the early stages of COPD and becomes more widespread over time as the disease progresses to
        more severe COPD Exacerbations are an acute worsening of symptoms resulting in additional
        therapy and can be classified as mild, moderate, or severe, Exacerbations are associated with
        faster lung function decline and hospital admissions During both stable periods and
        exacerbations, there is increased neutrophilic inflammation in the airways of COPD subjects ,
        Neutrophilic inflammation is a common feature of many airway diseases and is associated with
        disease progression, often irrespective of the initiating cause or underlying diagnosis The
        aim of this work is to study the relationship between neutrophilic airway inflammation, small
        airways dysfunction, and frequency of acute exacerbation in stable COPD patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: prospective correlational study
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Correlation between neutrophilic airway inflammation and stable COPD patients
  time frame: one year
  description: Concentration of neutrophilic count (cell/ml)in BAL
  measure: Correlation between frequency of acute exacerbation and stable COPD patients
  time frame: One year
  description: Rate of exacerbation / year
  arm group label: Infrequent exacerbators (IFE) group
  arm group type: Active Comparator
  description: 15 patients with infrequent exacerbation (IFE) "≤1 exacerbation per year in the preceding 12 months before enrolment.
  arm group label: Frequent exacerbators (FE) group
  arm group type: Active Comparator
  description: 15 patients with frequent exacerbation(FE) "≥ 2 per year in the preceding 12 months before enrolment
  intervention type: Procedure
  intervention name: Bronchoscopy
  description: Bronchoscopy and broncho-alveolar lavage (BAL) to assess neutrophilic count in BAL as a measurement of airway inflammation
  arm group label: Frequent exacerbators (FE) group
  arm group label: Infrequent exacerbators (IFE) group
  other name: body Plethysmography (RV/TLC)
  other name: Spirometry "pre and post bronchdilator to show poorly reversible airway obstruobstructin
  other name: CT-chest (Paired Inspiratory and expiratory HRCT scan) and measuring mean lung density
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Mohamed AbdElmoniem, lecturer
  role: Principal Investigator
  affiliation: Mansoura university Faculty of medicine
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Mansoura University Hospital
  investigator full name: Mohamed Abd Elmoniem Mohamed
  investigator title: Assistant lecturer
  mesh term: Inflammation
  sharing ipd: No