<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/NCT03282526</url>
  </required_header>
  <id_info>
    <org_study_id>PFTs in COPD</org_study_id>
    <nct_id>NCT03282526</nct_id>
  </id_info>
  <brief_title>Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease</brief_title>
  <official_title>Volume Parameters Vs Flow Parameters In Assessment Of Reversibility In Stable Chronic Obstructive Pulmonary Disease Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  Assess the differences between flow and volume responses after bronchodilator&#xD;
           reversibility testing in patients over different clinical chronic obstructive pulmonary&#xD;
           disease stages (GOLD stage I to GOLD stage IV).&#xD;
&#xD;
        -  Study the Correlation between the bronchodilator response and the severity of the&#xD;
           disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      chronic obstructive pulmonary disease is a common preventable and treatable disease&#xD;
      characterized by persistent airflow limitation that is usually progressive. The diagnosis&#xD;
      requires an evidence of obstructive pattern by spirometry measured before and after&#xD;
      bronchodilators.&#xD;
&#xD;
      The degree of reversibility of airflow obstruction differs between patients, and does not&#xD;
      predict the response to bronchodilator therapy. It can be seen in terms of forced vital&#xD;
      capacity (FVC) or forced expiratory volume in the first second (FEV1),or Inspiratory capacity&#xD;
      (IC) or residual volume (RV).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 30, 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assess the response pattern to inhaled short acting B2 agonist</measure>
    <time_frame>twice per day one before inhaled short acting B2 agonist and one after 10 minutes from inhaled short acting B2 agonist for average of 2 year</time_frame>
    <description>Assess the response pattern to inhaled short acting B2 agonist through measuring flow and volume parameters to define the differences between volumes responders and flow responders</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Whole body plethysmography</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>spirometery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Whole body plethysmography</intervention_name>
    <description>Whole body plethysmography : measure lung volumes Spirometry : to assess severity of chronic obstructive pulmonary disease also reversibility testing</description>
    <arm_group_label>Whole body plethysmography</arm_group_label>
    <arm_group_label>spirometery</arm_group_label>
    <other_name>Spirometry</other_name>
    <other_name>Plain chest radiograph</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients Clinical diagnosis of Chronic Obstructive Pulmonary Disease&#xD;
&#xD;
          -  Must be able to do pulmonary function test&#xD;
&#xD;
          -  Age more than 40 years&#xD;
&#xD;
          -  Stable Chronic Obstructive Pulmonary Disease patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Any patients with a diagnosis of:&#xD;
&#xD;
          -  Bronchial asthma&#xD;
&#xD;
          -  Bronchiectasis&#xD;
&#xD;
          -  Respiratory failure&#xD;
&#xD;
          -  Decompensated core pulmonale&#xD;
&#xD;
          -  Chronic Obstructive Pulmonary Disease combined with any other respiratory disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>AZZA BAHAA EL-DIN ALI</last_name>
    <phone>01090078962</phone>
    <email>zozo8928@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gamal Mohamed Rabie</last_name>
    <phone>01221729476</phone>
  </overall_contact_backup>
  <results_reference>
    <citation>Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Chen R, Decramer M, Fabbri LM, Frith P, Halpin DMG, Varela MVL, Nishimura M, Roche N, Rodriguez-Roisin R, Sin DD, Singh D, Stockley R, Vestbo J, Wedzicha JA, Agusti A. Erratum to &quot;Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report: GOLD Executive Summary&quot; [Arch Bronconeumol. 2017;53:128-49]. Arch Bronconeumol. 2017 Jul;53(7):411-412. doi: 10.1016/j.arbres.2017.06.001. No abstract available. English, Spanish.</citation>
    <PMID>28668138</PMID>
  </results_reference>
  <results_reference>
    <citation>&quot;Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report: GOLD Executive Summary.&quot; Claus F. Vogelmeier, Gerard J. Criner, Fernando J. Martinez, Antonio Anzueto, Peter J. Barnes, Jean Bourbeau, Bartolome R. Celli, Rongchang Chen, Marc Decramer, Leonardo M. Fabbri, Peter Frith, David M.G. Halpin, M. Victorina Lopez Varela, Masaharu Nishimura, Nicolas Roche, Roberto Rodriguez-Roisin, Don D. Sin, Dave Singh, Robert Stockley, Jorgen Vestbo, Jadwiga A. Wedzicha and Alvar Agusti. Eur Respir J 2017; 49: 1700214. Eur Respir J. 2017 Jun 22;49(6):1750214. doi: 10.1183/13993003.50214-2017. Print 2017 Jun. No abstract available.</citation>
    <PMID>28642306</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Azza Bahaa El-Din Ali Mohamed</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>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03282526
org study id: PFTs in COPD
nct id: NCT03282526
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
-  Assess the differences between flow and volume responses after bronchodilator
           reversibility testing in patients over different clinical chronic obstructive pulmonary
           disease stages (GOLD stage I to GOLD stage IV).

        -  Study the Correlation between the bronchodilator response and the severity of the
           disease.
chronic obstructive pulmonary disease is a common preventable and treatable disease
      characterized by persistent airflow limitation that is usually progressive. The diagnosis
      requires an evidence of obstructive pattern by spirometry measured before and after
      bronchodilators.

      The degree of reversibility of airflow obstruction differs between patients, and does not
      predict the response to bronchodilator therapy. It can be seen in terms of forced vital
      capacity (FVC) or forced expiratory volume in the first second (FEV1),or Inspiratory capacity
      (IC) or residual volume (RV).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Double (Participant, Investigator)
measure: Assess the response pattern to inhaled short acting B2 agonist
time frame: twice per day one before inhaled short acting B2 agonist and one after 10 minutes from inhaled short acting B2 agonist for average of 2 year
description: Assess the response pattern to inhaled short acting B2 agonist through measuring flow and volume parameters to define the differences between volumes responders and flow responders
arm group label: Whole body plethysmography
arm group type: Experimental
arm group label: spirometery
arm group type: Active Comparator
intervention type: Diagnostic Test
intervention name: Whole body plethysmography
description: Whole body plethysmography : measure lung volumes Spirometry : to assess severity of chronic obstructive pulmonary disease also reversibility testing
arm group label: Whole body plethysmography
arm group label: spirometery
other name: Spirometry
other name: Plain chest radiograph
criteria: 
gender: All
minimum age: 40 Years
maximum age: 60 Years
healthy volunteers: No
last name: AZZA BAHAA EL-DIN ALI
phone: 01090078962
email: zozo8928@yahoo.com
last name: Gamal Mohamed Rabie
phone: 01221729476
citation: Vogelmeier CF, Criner GJ, Martinez FJ, Anzueto A, Barnes PJ, Bourbeau J, Celli BR, Chen R, Decramer M, Fabbri LM, Frith P, Halpin DMG, Varela MVL, Nishimura M, Roche N, Rodriguez-Roisin R, Sin DD, Singh D, Stockley R, Vestbo J, Wedzicha JA, Agusti A. Erratum to "Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report: GOLD Executive Summary" [Arch Bronconeumol. 2017;53:128-49]. Arch Bronconeumol. 2017 Jul;53(7):411-412. doi: 10.1016/j.arbres.2017.06.001. No abstract available. English, Spanish.
PMID: 28668138
citation: "Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Lung Disease 2017 Report: GOLD Executive Summary." Claus F. Vogelmeier, Gerard J. Criner, Fernando J. Martinez, Antonio Anzueto, Peter J. Barnes, Jean Bourbeau, Bartolome R. Celli, Rongchang Chen, Marc Decramer, Leonardo M. Fabbri, Peter Frith, David M.G. Halpin, M. Victorina Lopez Varela, Masaharu Nishimura, Nicolas Roche, Roberto Rodriguez-Roisin, Don D. Sin, Dave Singh, Robert Stockley, Jorgen Vestbo, Jadwiga A. Wedzicha and Alvar Agusti. Eur Respir J 2017; 49: 1700214. Eur Respir J. 2017 Jun 22;49(6):1750214. doi: 10.1183/13993003.50214-2017. Print 2017 Jun. No abstract available.
PMID: 28642306
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Azza Bahaa El-Din Ali Mohamed
investigator title: Principal Investigator
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No