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/NCT05980611</url>
    </required_header>
    <id_info>
      <org_study_id>nasal IL B,IL 3 ,COPD</org_study_id>
      <nct_id>NCT05980611</nct_id>
    </id_info>
    <brief_title>Nasal IL 1 Beta ,IL 3 Level and Their Effects in COPD Patients</brief_title>
    <official_title>Evaluation of Nasal IL 1 Beta ,IL 3 Level and Their Effects on Disease Severity in COPD</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <brief_summary>
      <textblock>
        Chronic obstructive pulmonary disease is associated with systemic and local inflammation.&#xD;
        exposure to harmful gases and particles play important role in initiating the inflammatory&#xD;
        processes leading to the development of COPD. In high- and medium-income countries, tobacco&#xD;
        smoking is considered the predominant source of these noxious elements.1 Asthma, COPD,&#xD;
        rhinitis and rhinosinusitis (RS) are chronic diseases of the respiratory tract with an&#xD;
        estimated global prevalence of about 12%.2The concept of united airways diseases (UAD) was&#xD;
        formulated on the initial observation of the coexistence of allergic rhinitis and chronic&#xD;
        rhinosinusitis with asthma.3&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        . COPD patients asscioted with upper airway disease either high symptoms or low symptoms&#xD;
        according to The 22-item Sino Nasal Outcome Test .Data will be collected through: History and&#xD;
        examination of the upper airways and COPD symptomatology. History of smoking, medication,&#xD;
        admission and acute exacerbation . Pulmonary function tests to confirm diagnosis and degree&#xD;
        of obstruction. Diagnosis of COPD will be confirmed by the presence of irreversible airflow&#xD;
        obstruction, post-bronchodilator FEV1/FVC ratio of less than 0.7. Severity of airflow&#xD;
        obstruction will be graded according to the GOLD criteria [9] using CAT questionnaire to&#xD;
        assess degree of COPD burden.[10] The 22-item Sino Nasal Outcome Test (SNOT22) will assess&#xD;
        chronic rhinosinusitis symptoms and includes nasal and more general symptoms such as fatigue&#xD;
        [11]. Each symptom is scored from 0 (no symptoms) to 5 (symptoms as bad as they can be&quot;). The&#xD;
        maximum score is 110, with an MCID of 9 points [12].&#xD;
  &#xD;
        The SNOT22 nasal subdomain (SNOT22nasal) consists of seven questions (no. 1-5 + 7-8), which&#xD;
        include: &quot;need to blow nose&quot;, &quot;sneezing&quot;, &quot;runny nose&quot;, &quot;nasal obstruction&quot;, &quot;loss of smell&#xD;
        or taste&quot;, &quot;post-nasal discharge&quot; and &quot;thick nasal discharge&quot;. A cut-off for normality (or&#xD;
        MCID) has been not validated, however the total SNOT22 has been found to have a median score&#xD;
        of 7 points in healthy volunteers [12] Clinical markers in COPD symptom severity: Dyspnea&#xD;
        will be graded using the mMRC 5-point scale.13 Physical Activity The 6MWD will be measured in&#xD;
        accordance with the standard protocol with modifications.14 The latter were a shorter walking&#xD;
        lap of 50 m instead of 60 m . Participants rested for 10 min before the test and then&#xD;
        followed a straight corridor with a length of 25 m which was marked every 5 m. The turnaround&#xD;
        points were set up with a red cone, and the distance walked in 6 minutes was recorded.&#xD;
        Standardized phrases of encouragement were given during the test. Disease-specific HRQoL for&#xD;
        COPD was measured by the CAT and the SGRQ questionnaires. The range of the total score is&#xD;
        from 0 to 40 for the former and from 0 to 100 for the latter questionnaire, and high scores&#xD;
        are indicative of poorer HRQoL&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>degree of Upper Airway inflammation and severity of COPD</measure>
      <time_frame>1 year</time_frame>
      <description>patients with high UAD mostly affect degree of obstruction which assessed by FEV1 in PFT</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>high UAD and severity of COPD togeher and impact on quality of life in those patients</measure>
      <time_frame>1 year</time_frame>
      <description>patients with copd and nasal involvement and quality of life by using saint george questionnaire</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">75</enrollment>
    <condition>Copd Patients</condition>
    <arm_group>
      <arm_group_label>copd patients with high upper airway symptoms</arm_group_label>
      <description>The SNOT22 nasal subdomain (SNOT22nasal) consists of seven questions (no. 1-5 + 7-8), which include: &quot;need to blow nose&quot;, &quot;sneezing&quot;, &quot;runny nose&quot;, &quot;nasal obstruction&quot;, &quot;loss of smell or taste&quot;, &quot;post-nasal discharge&quot; and &quot;thick nasal discharge&quot;. the total SNOT22 has been found to have a median score of 7 points in healthy volunteers</description>
    </arm_group>
    <arm_group>
      <arm_group_label>copd patients with low upper airway symptoms</arm_group_label>
      <description>The SNOT22 nasal subdomain (SNOT22nasal) consists of seven questions (no. 1-5 + 7-8), which include: &quot;need to blow nose&quot;, &quot;sneezing&quot;, &quot;runny nose&quot;, &quot;nasal obstruction&quot;, &quot;loss of smell or taste&quot;, &quot;post-nasal discharge&quot; and &quot;thick nasal discharge&quot;. the total SNOT22 has been found to have a median score of 7 points in healthy volunteers</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>IL B,IL 3 in nasal swap and serum</intervention_name>
      <description>Interleukin (IL)-1-beta and IL-3 will be measured in patients' serum and supernatant from the nasal swap using enzyme linked immunosorbent assay (ELISA).</description>
      <arm_group_label>copd patients with high upper airway symptoms</arm_group_label>
      <arm_group_label>copd patients with low upper airway symptoms</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          copd patients&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:We included patients according to the following inclusion criteria:&#xD;
  &#xD;
            -  age ≥ 40 years&#xD;
  &#xD;
            -  History of smoking &gt; ten pack-years of tobacco&#xD;
  &#xD;
            -  Post- bronchodilator Forced Expiratory Volume 1 s (FEV1)/Forced Vital Capacity (FVC)&#xD;
               index &lt;0.70.&#xD;
  &#xD;
          Exclusion Criteria:self-reported or physician- diagnosed asthma and reversibility for beta&#xD;
          2 agonist above 400 ml and 15% from baseline FEV1&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Nermen mohamed abuelkassem, lecturer</last_name>
      <phone>01000767713</phone>
      <email>nermenabuelkassem@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Maha Ali Essameldeen, lecturer</last_name>
      <phone>01091570963</phone>
      <email>Mahaali@aun.edu.eg</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 5, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Nermen Abuelkassem</investigator_full_name>
      <investigator_title>lecturer</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05980611
  org study id: nasal IL B,IL 3 ,COPD
  nct id: NCT05980611
  lead sponsor: 
  Chronic obstructive pulmonary disease is associated with systemic and local inflammation.
        exposure to harmful gases and particles play important role in initiating the inflammatory
        processes leading to the development of COPD. In high- and medium-income countries, tobacco
        smoking is considered the predominant source of these noxious elements.1 Asthma, COPD,
        rhinitis and rhinosinusitis (RS) are chronic diseases of the respiratory tract with an
        estimated global prevalence of about 12%.2The concept of united airways diseases (UAD) was
        formulated on the initial observation of the coexistence of allergic rhinitis and chronic
        rhinosinusitis with asthma.3
  . COPD patients asscioted with upper airway disease either high symptoms or low symptoms
        according to The 22-item Sino Nasal Outcome Test .Data will be collected through: History and
        examination of the upper airways and COPD symptomatology. History of smoking, medication,
        admission and acute exacerbation . Pulmonary function tests to confirm diagnosis and degree
        of obstruction. Diagnosis of COPD will be confirmed by the presence of irreversible airflow
        obstruction, post-bronchodilator FEV1/FVC ratio of less than 0.7. Severity of airflow
        obstruction will be graded according to the GOLD criteria [9] using CAT questionnaire to
        assess degree of COPD burden.[10] The 22-item Sino Nasal Outcome Test (SNOT22) will assess
        chronic rhinosinusitis symptoms and includes nasal and more general symptoms such as fatigue
        [11]. Each symptom is scored from 0 (no symptoms) to 5 (symptoms as bad as they can be"). The
        maximum score is 110, with an MCID of 9 points [12].
  
        The SNOT22 nasal subdomain (SNOT22nasal) consists of seven questions (no. 1-5 + 7-8), which
        include: "need to blow nose", "sneezing", "runny nose", "nasal obstruction", "loss of smell
        or taste", "post-nasal discharge" and "thick nasal discharge". A cut-off for normality (or
        MCID) has been not validated, however the total SNOT22 has been found to have a median score
        of 7 points in healthy volunteers [12] Clinical markers in COPD symptom severity: Dyspnea
        will be graded using the mMRC 5-point scale.13 Physical Activity The 6MWD will be measured in
        accordance with the standard protocol with modifications.14 The latter were a shorter walking
        lap of 50 m instead of 60 m . Participants rested for 10 min before the test and then
        followed a straight corridor with a length of 25 m which was marked every 5 m. The turnaround
        points were set up with a red cone, and the distance walked in 6 minutes was recorded.
        Standardized phrases of encouragement were given during the test. Disease-specific HRQoL for
        COPD was measured by the CAT and the SGRQ questionnaires. The range of the total score is
        from 0 to 40 for the former and from 0 to 100 for the latter questionnaire, and high scores
        are indicative of poorer HRQoL
  observational model: Other
  time perspective: Cross-Sectional
  measure: degree of Upper Airway inflammation and severity of COPD
  time frame: 1 year
  description: patients with high UAD mostly affect degree of obstruction which assessed by FEV1 in PFT
  measure: high UAD and severity of COPD togeher and impact on quality of life in those patients
  time frame: 1 year
  description: patients with copd and nasal involvement and quality of life by using saint george questionnaire
  arm group label: copd patients with high upper airway symptoms
  description: The SNOT22 nasal subdomain (SNOT22nasal) consists of seven questions (no. 1-5 + 7-8), which include: "need to blow nose", "sneezing", "runny nose", "nasal obstruction", "loss of smell or taste", "post-nasal discharge" and "thick nasal discharge". the total SNOT22 has been found to have a median score of 7 points in healthy volunteers
  arm group label: copd patients with low upper airway symptoms
  description: The SNOT22 nasal subdomain (SNOT22nasal) consists of seven questions (no. 1-5 + 7-8), which include: "need to blow nose", "sneezing", "runny nose", "nasal obstruction", "loss of smell or taste", "post-nasal discharge" and "thick nasal discharge". the total SNOT22 has been found to have a median score of 7 points in healthy volunteers
  intervention type: Diagnostic Test
  intervention name: IL B,IL 3 in nasal swap and serum
  description: Interleukin (IL)-1-beta and IL-3 will be measured in patients' serum and supernatant from the nasal swap using enzyme linked immunosorbent assay (ELISA).
  arm group label: copd patients with high upper airway symptoms
  arm group label: copd patients with low upper airway symptoms
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Nermen mohamed abuelkassem, lecturer
  phone: 01000767713
  email: nermenabuelkassem@gmail.com
  last name: Maha Ali Essameldeen, lecturer
  phone: 01091570963
  email: Mahaali@aun.edu.eg
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Nermen Abuelkassem
  investigator title: lecturer
  sharing ipd: Undecided