<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/NCT03839992</url>
  </required_header>
  <id_info>
    <org_study_id>MHS #843-18</org_study_id>
    <nct_id>NCT03839992</nct_id>
  </id_info>
  <brief_title>Detection of Unsuspected Small Airways Obstruction in Cystic Fibrosis</brief_title>
  <official_title>The Measurement and Analysis of Maximal Expiratory Flow Volume Loops at Low Lung Volumes in Children With Cystic Fibrosis and Normal Routine Lung Function.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gelb, Arthur F., M.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Miller Children's &amp; Women's Hospital Long Beach</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Stony Brook University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Gelb, Arthur F., M.D.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Goal is to physiologically detect unsuspected small airways obstruction in children and&#xD;
      adults with treated heterozygous and homozygous cystic fibrosis. Unsuspected refers to normal&#xD;
      routine pre bronchodilator spirometry including normal FEV1(L), FVC (L). and FEV1/FVC%. This&#xD;
      is a retrospective study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current study is based on current investigators previously published patho-physiologic&#xD;
      and lung CT studies in small airways intrinsic obstruction, emphysema, and asthma. Current&#xD;
      investigators have demonstrated that despite the presence of normal routine spirometry&#xD;
      including normal FEV1(L), FVC (L), and FEV1/FVC% that unsuspected small airways obstruction,&#xD;
      and emphysema can be detected. This has been achieved by presence of isolated abnormal&#xD;
      expiratory airflow limitation at low lung volumes on the maximal expiratory flow volume&#xD;
      curves. This includes abnormal expiratory airflow at 75% and 80% expired lung volume. Current&#xD;
      investigators believe investigators will be able to detect unsuspected small airways&#xD;
      intrinsic obstruction, and peripheral airway bronchiectasis proven by lung CT, in patients&#xD;
      with cystic fibrosis despite presence of pre bronchodilator normal routine spirometry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 25, 2018</start_date>
  <completion_date type="Anticipated">November 25, 2023</completion_date>
  <primary_completion_date type="Anticipated">April 25, 2023</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Detection of Unsuspected Small Airway Obstruction in Cystic Fibrosis</measure>
    <time_frame>5 years</time_frame>
    <description>Retrospective analysis of pre bronchodilator spirometry, and lung CT study to detect abnormal FEF75% in the presence of normal spirometry and FEF25-75. Detect isolated abnormal pre bronchodilator spirometry at 75%FVC</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Cystic Fibrosis in Children</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>spirometry</intervention_name>
    <description>measure spirometry and lung CT</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Review pulmonary function and radiologic studies in retrospective records of heterozygote&#xD;
        or homozygote patients with cystic fibrosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Heterozygote or homozygote patients with cystic fibrosis with normal routine pre&#xD;
        bronchodilator spirometry including normal FEV1(L), FVC(L) and FEV1/FVC%.&#xD;
&#xD;
        Exclusion Criteria:Heterozygote or homozygote patients with cystic fibrosis with ABNORMAL&#xD;
        routine pre bronchodilator spirometry&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arthur Gelb, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Arthur F Gelb, MD</last_name>
    <phone>562-565-5333</phone>
    <phone_ext>5625655333</phone_ext>
    <email>afgelb@msn.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Vicki Masson, MD</last_name>
    <phone>631-741-0549</phone>
    <phone_ext>5625655333</phone_ext>
    <email>vicki.masson@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Arthur F Gelb MD</name>
      <address>
        <city>Lakewood</city>
        <state>California</state>
        <zip>90712</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Arthur F Gelb, MD</last_name>
      <phone>562-633-2204</phone>
      <email>afgelb@msn.com</email>
    </contact>
    <contact_backup>
      <last_name>Christine Fraser</last_name>
      <phone>562-633-2204</phone>
      <email>familyfrase@msn.com</email>
    </contact_backup>
    <investigator>
      <last_name>Arthur F Gelb, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Miller Children's Hospital and Long Beach Medical Center</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vicki C Masson, MD</last_name>
      <phone>631-741-0549</phone>
      <phone_ext>6317410549</phone_ext>
      <email>vicki.masson@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Eli C Nussbaum, MD</last_name>
      <phone>714-356-6830</phone>
      <phone_ext>6317410549</phone_ext>
      <email>ENussbaum@memorialcare.org</email>
    </contact_backup>
    <investigator>
      <last_name>Vicki C Masson, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Mead J. The lung's &quot;quiet zone&quot;. N Engl J Med. 1970 Jun 4;282(23):1318-9. doi: 10.1056/NEJM197006042822311. No abstract available.</citation>
    <PMID>5442364</PMID>
  </results_reference>
  <results_reference>
    <citation>Gelb AF, Gold WM, Wright RR, Bruch HR, Nadel JA. Physiologic diagnosis of subclinical emphysema. Am Rev Respir Dis. 1973 Jan;107(1):50-63. doi: 10.1164/arrd.1973.107.1.50. No abstract available.</citation>
    <PMID>4683321</PMID>
  </results_reference>
  <results_reference>
    <citation>Gelb AF, Zamel N. Simplified diagnosis of small-airway obstruction. N Engl J Med. 1973 Feb 22;288(8):395-8. doi: 10.1056/NEJM197302222880805. No abstract available.</citation>
    <PMID>4684043</PMID>
  </results_reference>
  <results_reference>
    <citation>Hogg JC, Pare PD, Hackett TL. The Contribution of Small Airway Obstruction to the Pathogenesis of Chronic Obstructive Pulmonary Disease. Physiol Rev. 2017 Apr;97(2):529-552. doi: 10.1152/physrev.00025.2015. Erratum In: Physiol Rev. 2018 Jul 1;98(3):1909.</citation>
    <PMID>28151425</PMID>
  </results_reference>
  <results_reference>
    <citation>Lukic KZ, Coates AL. Does the FEF25-75 or the FEF75 have any value in assessing lung disease in children with cystic fibrosis or asthma? Pediatr Pulmonol. 2015 Sep;50(9):863-8. doi: 10.1002/ppul.23234. Epub 2015 Jun 16.</citation>
    <PMID>26079395</PMID>
  </results_reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 5, 2021</last_update_submitted>
  <last_update_submitted_qc>February 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>abnormal FEF75</keyword>
  <keyword>bronchiectasis</keyword>
  <keyword>lung CT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All individual published data will be shared</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>when published</ipd_time_frame>
    <ipd_access_criteria>published data</ipd_access_criteria>
  </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/NCT03839992
org study id: MHS #843-18
nct id: NCT03839992
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
Goal is to physiologically detect unsuspected small airways obstruction in children and
      adults with treated heterozygous and homozygous cystic fibrosis. Unsuspected refers to normal
      routine pre bronchodilator spirometry including normal FEV1(L), FVC (L). and FEV1/FVC%. This
      is a retrospective study.
The current study is based on current investigators previously published patho-physiologic
      and lung CT studies in small airways intrinsic obstruction, emphysema, and asthma. Current
      investigators have demonstrated that despite the presence of normal routine spirometry
      including normal FEV1(L), FVC (L), and FEV1/FVC% that unsuspected small airways obstruction,
      and emphysema can be detected. This has been achieved by presence of isolated abnormal
      expiratory airflow limitation at low lung volumes on the maximal expiratory flow volume
      curves. This includes abnormal expiratory airflow at 75% and 80% expired lung volume. Current
      investigators believe investigators will be able to detect unsuspected small airways
      intrinsic obstruction, and peripheral airway bronchiectasis proven by lung CT, in patients
      with cystic fibrosis despite presence of pre bronchodilator normal routine spirometry.
observational model: Cohort
time perspective: Retrospective
measure: Detection of Unsuspected Small Airway Obstruction in Cystic Fibrosis
time frame: 5 years
description: Retrospective analysis of pre bronchodilator spirometry, and lung CT study to detect abnormal FEF75% in the presence of normal spirometry and FEF25-75. Detect isolated abnormal pre bronchodilator spirometry at 75%FVC
intervention type: Diagnostic Test
intervention name: spirometry
description: measure spirometry and lung CT
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 40 Years
healthy volunteers: No
last name: Arthur Gelb, MD
role: Principal Investigator
affiliation: University of California, Los Angeles
last name: Arthur F Gelb, MD
phone: 562-565-5333
phone ext: 5625655333
email: afgelb@msn.com
last name: Vicki Masson, MD
phone: 631-741-0549
phone ext: 5625655333
email: vicki.masson@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
citation: Mead J. The lung's "quiet zone". N Engl J Med. 1970 Jun 4;282(23):1318-9. doi: 10.1056/NEJM197006042822311. No abstract available.
PMID: 5442364
citation: Gelb AF, Gold WM, Wright RR, Bruch HR, Nadel JA. Physiologic diagnosis of subclinical emphysema. Am Rev Respir Dis. 1973 Jan;107(1):50-63. doi: 10.1164/arrd.1973.107.1.50. No abstract available.
PMID: 4683321
citation: Gelb AF, Zamel N. Simplified diagnosis of small-airway obstruction. N Engl J Med. 1973 Feb 22;288(8):395-8. doi: 10.1056/NEJM197302222880805. No abstract available.
PMID: 4684043
citation: Hogg JC, Pare PD, Hackett TL. The Contribution of Small Airway Obstruction to the Pathogenesis of Chronic Obstructive Pulmonary Disease. Physiol Rev. 2017 Apr;97(2):529-552. doi: 10.1152/physrev.00025.2015. Erratum In: Physiol Rev. 2018 Jul 1;98(3):1909.
PMID: 28151425
citation: Lukic KZ, Coates AL. Does the FEF25-75 or the FEF75 have any value in assessing lung disease in children with cystic fibrosis or asthma? Pediatr Pulmonol. 2015 Sep;50(9):863-8. doi: 10.1002/ppul.23234. Epub 2015 Jun 16.
PMID: 26079395
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Fibrosis
sharing ipd: Yes
ipd description: All individual published data will be shared
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: when published
ipd access criteria: published data