<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/NCT03263130</url>
  </required_header>
  <id_info>
    <org_study_id>1234567</org_study_id>
    <nct_id>NCT03263130</nct_id>
  </id_info>
  <brief_title>Site and Mechanism(s) of Expiratory Airflow Limitation in COPD, Emphysema and Asthma-COPD Overlap</brief_title>
  <official_title>Site and Mechanism(s) of Expiratory Airflow Limitation in COPD, Emphysema and Asthma-COPD Overlap</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gelb, Arthur F., M.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this cross-sectional, observational study is to evaluate the site and&#xD;
      mechanism(s) for expiratory airflow limitation in chronic, treated, current or former smokers&#xD;
      (&gt;15 pack years) with COPD, Emphysema, and Asthma-COPD Overlap with mild to severe expiratory&#xD;
      airflow limitation. Treatment may include short and long acting inhaled beta2agonists, short&#xD;
      and long acting inhaled muscarinic receptor antagonists, inhaled and or oral corticosteroid,&#xD;
      oral antibiotic, supplemental oxygen, and PDE type 4 inhibitor. In some cases, the patient&#xD;
      may have had a history of asthma preceding the development of COPD (Asthma COPD Overlap).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators are interested in determining the predominant site of expiratory airflow&#xD;
      limitation including large central airways vs small peripheral airways/alveoli. In mild to&#xD;
      moderate obstructive airways disease and emphysema, I believe routine spirometry including&#xD;
      FEV 1(L), FVC (L), and FEV 1/FVC % may be normal, despite expiratory airflow limitation in&#xD;
      lung peripheral airways. I also want to determine whether the mechanism(s) of expiratory&#xD;
      airflow limitation are related to measured loss of lung elastic recoil or intrinsic&#xD;
      obstruction of small peripheral airways or both. It is also important to determine the extent&#xD;
      and distribution of emphysema using high resolution, thin section lung CT with voxel&#xD;
      quantification. If available pathological analysis of lung surgical specimens and also&#xD;
      formalin inflated lungs obtained at autopsy will also be studied. Blood studies will include&#xD;
      but not limited to CBC, serum IgE, complete metabolic panel, and alpha 1 antitrypsin levels.&#xD;
      Extensive lung function testing will also include spirometry tests before and after inhaled&#xD;
      albuterol bronchodilation, lung volumes measured in a plethysmograph, diffusing capacity,&#xD;
      measurement of lung elasticity that requires placement of an esophageal balloon, measurement&#xD;
      of airflow after breathing a mixture of 80% helium-20%oxygen for 7-10 minutes, and&#xD;
      measurements of exhaled nitric oxide. CAT scans of the lungs will be obtained to evaluate the&#xD;
      presence, extent and distribution of emphysema and bronchiectasis. In some cases,&#xD;
      bronchoscopy may be requested.&#xD;
&#xD;
      The above tests may be uncomfortable but should cause no harm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>2 Months</target_duration>
  <primary_outcome>
    <measure>Site and Mechanism(s) of Expiratory Airflow Limitation</measure>
    <time_frame>4 years</time_frame>
    <description>Contribution of loss of lung lastic recoil vs intrinsic airway obstruction</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>COPD, Emphysema, Asthma COPD Overlap</condition>
  <condition>Emphysema</condition>
  <arm_group>
    <arm_group_label>COPD, Emphysema, Asthma-COPD Overlap</arm_group_label>
    <description>Based on clinical, pathologic, laboratory, physiologic and radiologic differences, patient groups can be described.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>As above: diagnosis: COPD, Emphysema, Asthma-COPD Overlap</intervention_name>
    <arm_group_label>COPD, Emphysema, Asthma-COPD Overlap</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        As above&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  asthma- copd overlap&#xD;
&#xD;
          -  emphysema in smokers with smoking history &gt; 15 pack years&#xD;
&#xD;
          -  COPD/ bronchitis and bronchiectasis in smokers with smoking history&#xD;
&#xD;
          -  &gt;15 pack years&#xD;
&#xD;
        Exclusion Criteria:other pulmonary or systemic diagnosis&#xD;
&#xD;
          -  non smokers&#xD;
&#xD;
          -  any other pulmonary diagnosis&#xD;
&#xD;
          -  pulmonary fibrosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arthur F Gelb, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clin Prof Geffen School of Medicine at UCLA Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Arthur F Gelb, MD</last_name>
    <role>Study Director</role>
    <affiliation>Clin Prof Geffen School of Medicine at UCLA Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Arthur F Gelb, MD</last_name>
    <phone>562-633-2204</phone>
    <email>afgelb@msn.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christine Fraser</last_name>
    <phone>562-633-2204</phone>
    <email>familyfrase@msn.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>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>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Qaseem A, Wilt TJ, Weinberger SE, Hanania NA, Criner G, van der Molen T, Marciniuk DD, Denberg T, Schunemann H, Wedzicha W, MacDonald R, Shekelle P; American College of Physicians; American College of Chest Physicians; American Thoracic Society; European Respiratory Society. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011 Aug 2;155(3):179-91. doi: 10.7326/0003-4819-155-3-201108020-00008.</citation>
    <PMID>21810710</PMID>
  </results_reference>
  <results_reference>
    <citation>Alcaide AB, Sanchez-Salcedo P, Bastarrika G, Campo A, Berto J, Ocon MD, Fernandez-Montero A, Celli BR, Zulueta JJ, de-Torres JP. Clinical Features of Smokers With Radiological Emphysema But Without Airway Limitation. Chest. 2017 Feb;151(2):358-365. doi: 10.1016/j.chest.2016.10.044. Epub 2016 Nov 3.</citation>
    <PMID>27818328</PMID>
  </results_reference>
  <results_reference>
    <citation>Mannino DM, Make BJ. Is it time to move beyond the &quot;O&quot; in early COPD? Eur Respir J. 2015 Dec;46(6):1535-7. doi: 10.1183/13993003.01436-2015. No abstract available.</citation>
    <PMID>26621878</PMID>
  </results_reference>
  <results_reference>
    <citation>Rennard SI, Drummond MB. Early chronic obstructive pulmonary disease: definition, assessment, and prevention. Lancet. 2015 May 2;385(9979):1778-1788. doi: 10.1016/S0140-6736(15)60647-X.</citation>
    <PMID>25943942</PMID>
  </results_reference>
  <results_reference>
    <citation>Harvey BG, Strulovici-Barel Y, Kaner RJ, Sanders A, Vincent TL, Mezey JG, Crystal RG. Risk of COPD with obstruction in active smokers with normal spirometry and reduced diffusion capacity. Eur Respir J. 2015 Dec;46(6):1589-1597. doi: 10.1183/13993003.02377-2014. Epub 2015 Nov 5.</citation>
    <PMID>26541521</PMID>
  </results_reference>
  <results_reference>
    <citation>Johns DP, Walters JA, Walters EH. Diagnosis and early detection of COPD using spirometry. J Thorac Dis. 2014 Nov;6(11):1557-69. doi: 10.3978/j.issn.2072-1439.2014.08.18.</citation>
    <PMID>25478197</PMID>
  </results_reference>
  <results_reference>
    <citation>Woodruff PG, Barr RG, Bleecker E, Christenson SA, Couper D, Curtis JL, Gouskova NA, Hansel NN, Hoffman EA, Kanner RE, Kleerup E, Lazarus SC, Martinez FJ, Paine R 3rd, Rennard S, Tashkin DP, Han MK; SPIROMICS Research Group. Clinical Significance of Symptoms in Smokers with Preserved Pulmonary Function. N Engl J Med. 2016 May 12;374(19):1811-21. doi: 10.1056/NEJMoa1505971.</citation>
    <PMID>27168432</PMID>
  </results_reference>
  <results_reference>
    <citation>Rodriguez-Roisin R, Han MK, Vestbo J, Wedzicha JA, Woodruff PG, Martinez FJ. Chronic Respiratory Symptoms with Normal Spirometry. A Reliable Clinical Entity? Am J Respir Crit Care Med. 2017 Jan 1;195(1):17-22. doi: 10.1164/rccm.201607-1376PP. No abstract available.</citation>
    <PMID>27598473</PMID>
  </results_reference>
  <results_reference>
    <citation>Martinez CH, Diaz AA, Meldrum C, Curtis JL, Cooper CB, Pirozzi C, Kanner RE, Paine R 3rd, Woodruff PG, Bleecker ER, Hansel NN, Barr RG, Marchetti N, Criner GJ, Kazerooni EA, Hoffman EA, Ross BD, Galban CJ, Cigolle CT, Martinez FJ, Han MK; SPIROMICS Investigators. Age and Small Airway Imaging Abnormalities in Subjects with and without Airflow Obstruction in SPIROMICS. Am J Respir Crit Care Med. 2017 Feb 15;195(4):464-472. doi: 10.1164/rccm.201604-0871OC.</citation>
    <PMID>27564413</PMID>
  </results_reference>
  <results_reference>
    <citation>Regan EA, Lynch DA, Curran-Everett D, Curtis JL, Austin JH, Grenier PA, Kauczor HU, Bailey WC, DeMeo DL, Casaburi RH, Friedman P, Van Beek EJ, Hokanson JE, Bowler RP, Beaty TH, Washko GR, Han MK, Kim V, Kim SS, Yagihashi K, Washington L, McEvoy CE, Tanner C, Mannino DM, Make BJ, Silverman EK, Crapo JD; Genetic Epidemiology of COPD (COPDGene) Investigators. Clinical and Radiologic Disease in Smokers With Normal Spirometry. JAMA Intern Med. 2015 Sep;175(9):1539-49. doi: 10.1001/jamainternmed.2015.2735. Erratum In: JAMA Intern Med. 2015 Sep;175(9):1588.</citation>
    <PMID>26098755</PMID>
  </results_reference>
  <results_reference>
    <citation>Gelb AF, Hogg JC, Muller NL, Schein MJ, Kuei J, Tashkin DP, Epstein JD, Kollin J, Green RH, Zamel N, Elliott WM, Hadjiaghai L. Contribution of emphysema and small airways in COPD. Chest. 1996 Feb;109(2):353-9. doi: 10.1378/chest.109.2.353.</citation>
    <PMID>8620705</PMID>
  </results_reference>
  <results_reference>
    <citation>Gelb AF, Schein M, Kuei J, Tashkin DP, Muller NL, Hogg JC, Epstein JD, Zamel N. Limited contribution of emphysema in advanced chronic obstructive pulmonary disease. Am Rev Respir Dis. 1993 May;147(5):1157-61. doi: 10.1164/ajrccm/147.5.1157.</citation>
    <PMID>8484625</PMID>
  </results_reference>
  <results_reference>
    <citation>Gelb AF, Yamamoto A, Verbeken EK, Nadel JA. Unraveling the Pathophysiology of the Asthma-COPD Overlap Syndrome: Unsuspected Mild Centrilobular Emphysema Is Responsible for Loss of Lung Elastic Recoil in Never Smokers With Asthma With Persistent Expiratory Airflow Limitation. Chest. 2015 Aug;148(2):313-320. doi: 10.1378/chest.14-2483.</citation>
    <PMID>25950858</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>Gelb AF, Williams AJ, Zamel N. Spirometry. FEV1 vs FEF25-75 percent. Chest. 1983 Oct;84(4):473-4. doi: 10.1378/chest.84.4.473. No abstract available.</citation>
    <PMID>6617285</PMID>
  </results_reference>
  <results_reference>
    <citation>Gelb AF, Yamamoto A, Mauad T, Kollin J, Schein MJ, Nadel JA. Unsuspected mild emphysema in nonsmoking patients with chronic asthma with persistent airway obstruction. J Allergy Clin Immunol. 2014 Jan;133(1):263-5.e1-3. doi: 10.1016/j.jaci.2013.09.045. Epub 2013 Nov 28. No abstract available. Erratum In: J Allergy Clin Immunol. 2014 Apr;133(4):1232.</citation>
    <PMID>24290280</PMID>
  </results_reference>
  <results_reference>
    <citation>Gelb AF, Yamamoto A, Verbeken EK, Schein MJ, Moridzadeh R, Tran D, Fraser C, Barbers R, Elatre W, Koss MN, Glassy EF, Nadel JA. Further Studies of Unsuspected Emphysema in Nonsmoking Patients With Asthma With Persistent Expiratory Airflow Obstruction. Chest. 2018 Mar;153(3):618-629. doi: 10.1016/j.chest.2017.11.016. Epub 2017 Nov 29.</citation>
    <PMID>29197547</PMID>
  </results_reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</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 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD, Emphysema, Asthma COPD Overlap</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
    <mesh_term>Pulmonary Emphysema</mesh_term>
    <mesh_term>Emphysema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Results of tests</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>As indicated for collaborration</ipd_time_frame>
    <ipd_access_criteria>within 2 weeks of testing</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/NCT03263130
org study id: 1234567
nct id: NCT03263130
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this cross-sectional, observational study is to evaluate the site and
      mechanism(s) for expiratory airflow limitation in chronic, treated, current or former smokers
      (>15 pack years) with COPD, Emphysema, and Asthma-COPD Overlap with mild to severe expiratory
      airflow limitation. Treatment may include short and long acting inhaled beta2agonists, short
      and long acting inhaled muscarinic receptor antagonists, inhaled and or oral corticosteroid,
      oral antibiotic, supplemental oxygen, and PDE type 4 inhibitor. In some cases, the patient
      may have had a history of asthma preceding the development of COPD (Asthma COPD Overlap).
The investigators are interested in determining the predominant site of expiratory airflow
      limitation including large central airways vs small peripheral airways/alveoli. In mild to
      moderate obstructive airways disease and emphysema, I believe routine spirometry including
      FEV 1(L), FVC (L), and FEV 1/FVC % may be normal, despite expiratory airflow limitation in
      lung peripheral airways. I also want to determine whether the mechanism(s) of expiratory
      airflow limitation are related to measured loss of lung elastic recoil or intrinsic
      obstruction of small peripheral airways or both. It is also important to determine the extent
      and distribution of emphysema using high resolution, thin section lung CT with voxel
      quantification. If available pathological analysis of lung surgical specimens and also
      formalin inflated lungs obtained at autopsy will also be studied. Blood studies will include
      but not limited to CBC, serum IgE, complete metabolic panel, and alpha 1 antitrypsin levels.
      Extensive lung function testing will also include spirometry tests before and after inhaled
      albuterol bronchodilation, lung volumes measured in a plethysmograph, diffusing capacity,
      measurement of lung elasticity that requires placement of an esophageal balloon, measurement
      of airflow after breathing a mixture of 80% helium-20%oxygen for 7-10 minutes, and
      measurements of exhaled nitric oxide. CAT scans of the lungs will be obtained to evaluate the
      presence, extent and distribution of emphysema and bronchiectasis. In some cases,
      bronchoscopy may be requested.

      The above tests may be uncomfortable but should cause no harm.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Site and Mechanism(s) of Expiratory Airflow Limitation
time frame: 4 years
description: Contribution of loss of lung lastic recoil vs intrinsic airway obstruction
arm group label: COPD, Emphysema, Asthma-COPD Overlap
description: Based on clinical, pathologic, laboratory, physiologic and radiologic differences, patient groups can be described.
intervention type: Other
intervention name: As above: diagnosis: COPD, Emphysema, Asthma-COPD Overlap
arm group label: COPD, Emphysema, Asthma-COPD Overlap
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Arthur F Gelb, MD
role: Principal Investigator
affiliation: Clin Prof Geffen School of Medicine at UCLA Medical Center
last name: Arthur F Gelb, MD
role: Study Director
affiliation: Clin Prof Geffen School of Medicine at UCLA Medical Center
last name: Arthur F Gelb, MD
phone: 562-633-2204
email: afgelb@msn.com
last name: Christine Fraser
phone: 562-633-2204
email: familyfrase@msn.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
citation: Qaseem A, Wilt TJ, Weinberger SE, Hanania NA, Criner G, van der Molen T, Marciniuk DD, Denberg T, Schunemann H, Wedzicha W, MacDonald R, Shekelle P; American College of Physicians; American College of Chest Physicians; American Thoracic Society; European Respiratory Society. Diagnosis and management of stable chronic obstructive pulmonary disease: a clinical practice guideline update from the American College of Physicians, American College of Chest Physicians, American Thoracic Society, and European Respiratory Society. Ann Intern Med. 2011 Aug 2;155(3):179-91. doi: 10.7326/0003-4819-155-3-201108020-00008.
PMID: 21810710
citation: Alcaide AB, Sanchez-Salcedo P, Bastarrika G, Campo A, Berto J, Ocon MD, Fernandez-Montero A, Celli BR, Zulueta JJ, de-Torres JP. Clinical Features of Smokers With Radiological Emphysema But Without Airway Limitation. Chest. 2017 Feb;151(2):358-365. doi: 10.1016/j.chest.2016.10.044. Epub 2016 Nov 3.
PMID: 27818328
citation: Mannino DM, Make BJ. Is it time to move beyond the "O" in early COPD? Eur Respir J. 2015 Dec;46(6):1535-7. doi: 10.1183/13993003.01436-2015. No abstract available.
PMID: 26621878
citation: Rennard SI, Drummond MB. Early chronic obstructive pulmonary disease: definition, assessment, and prevention. Lancet. 2015 May 2;385(9979):1778-1788. doi: 10.1016/S0140-6736(15)60647-X.
PMID: 25943942
citation: Harvey BG, Strulovici-Barel Y, Kaner RJ, Sanders A, Vincent TL, Mezey JG, Crystal RG. Risk of COPD with obstruction in active smokers with normal spirometry and reduced diffusion capacity. Eur Respir J. 2015 Dec;46(6):1589-1597. doi: 10.1183/13993003.02377-2014. Epub 2015 Nov 5.
PMID: 26541521
citation: Johns DP, Walters JA, Walters EH. Diagnosis and early detection of COPD using spirometry. J Thorac Dis. 2014 Nov;6(11):1557-69. doi: 10.3978/j.issn.2072-1439.2014.08.18.
PMID: 25478197
citation: Woodruff PG, Barr RG, Bleecker E, Christenson SA, Couper D, Curtis JL, Gouskova NA, Hansel NN, Hoffman EA, Kanner RE, Kleerup E, Lazarus SC, Martinez FJ, Paine R 3rd, Rennard S, Tashkin DP, Han MK; SPIROMICS Research Group. Clinical Significance of Symptoms in Smokers with Preserved Pulmonary Function. N Engl J Med. 2016 May 12;374(19):1811-21. doi: 10.1056/NEJMoa1505971.
PMID: 27168432
citation: Rodriguez-Roisin R, Han MK, Vestbo J, Wedzicha JA, Woodruff PG, Martinez FJ. Chronic Respiratory Symptoms with Normal Spirometry. A Reliable Clinical Entity? Am J Respir Crit Care Med. 2017 Jan 1;195(1):17-22. doi: 10.1164/rccm.201607-1376PP. No abstract available.
PMID: 27598473
citation: Martinez CH, Diaz AA, Meldrum C, Curtis JL, Cooper CB, Pirozzi C, Kanner RE, Paine R 3rd, Woodruff PG, Bleecker ER, Hansel NN, Barr RG, Marchetti N, Criner GJ, Kazerooni EA, Hoffman EA, Ross BD, Galban CJ, Cigolle CT, Martinez FJ, Han MK; SPIROMICS Investigators. Age and Small Airway Imaging Abnormalities in Subjects with and without Airflow Obstruction in SPIROMICS. Am J Respir Crit Care Med. 2017 Feb 15;195(4):464-472. doi: 10.1164/rccm.201604-0871OC.
PMID: 27564413
citation: Regan EA, Lynch DA, Curran-Everett D, Curtis JL, Austin JH, Grenier PA, Kauczor HU, Bailey WC, DeMeo DL, Casaburi RH, Friedman P, Van Beek EJ, Hokanson JE, Bowler RP, Beaty TH, Washko GR, Han MK, Kim V, Kim SS, Yagihashi K, Washington L, McEvoy CE, Tanner C, Mannino DM, Make BJ, Silverman EK, Crapo JD; Genetic Epidemiology of COPD (COPDGene) Investigators. Clinical and Radiologic Disease in Smokers With Normal Spirometry. JAMA Intern Med. 2015 Sep;175(9):1539-49. doi: 10.1001/jamainternmed.2015.2735. Erratum In: JAMA Intern Med. 2015 Sep;175(9):1588.
PMID: 26098755
citation: Gelb AF, Hogg JC, Muller NL, Schein MJ, Kuei J, Tashkin DP, Epstein JD, Kollin J, Green RH, Zamel N, Elliott WM, Hadjiaghai L. Contribution of emphysema and small airways in COPD. Chest. 1996 Feb;109(2):353-9. doi: 10.1378/chest.109.2.353.
PMID: 8620705
citation: Gelb AF, Schein M, Kuei J, Tashkin DP, Muller NL, Hogg JC, Epstein JD, Zamel N. Limited contribution of emphysema in advanced chronic obstructive pulmonary disease. Am Rev Respir Dis. 1993 May;147(5):1157-61. doi: 10.1164/ajrccm/147.5.1157.
PMID: 8484625
citation: Gelb AF, Yamamoto A, Verbeken EK, Nadel JA. Unraveling the Pathophysiology of the Asthma-COPD Overlap Syndrome: Unsuspected Mild Centrilobular Emphysema Is Responsible for Loss of Lung Elastic Recoil in Never Smokers With Asthma With Persistent Expiratory Airflow Limitation. Chest. 2015 Aug;148(2):313-320. doi: 10.1378/chest.14-2483.
PMID: 25950858
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: Gelb AF, Williams AJ, Zamel N. Spirometry. FEV1 vs FEF25-75 percent. Chest. 1983 Oct;84(4):473-4. doi: 10.1378/chest.84.4.473. No abstract available.
PMID: 6617285
citation: Gelb AF, Yamamoto A, Mauad T, Kollin J, Schein MJ, Nadel JA. Unsuspected mild emphysema in nonsmoking patients with chronic asthma with persistent airway obstruction. J Allergy Clin Immunol. 2014 Jan;133(1):263-5.e1-3. doi: 10.1016/j.jaci.2013.09.045. Epub 2013 Nov 28. No abstract available. Erratum In: J Allergy Clin Immunol. 2014 Apr;133(4):1232.
PMID: 24290280
citation: Gelb AF, Yamamoto A, Verbeken EK, Schein MJ, Moridzadeh R, Tran D, Fraser C, Barbers R, Elatre W, Koss MN, Glassy EF, Nadel JA. Further Studies of Unsuspected Emphysema in Nonsmoking Patients With Asthma With Persistent Expiratory Airflow Obstruction. Chest. 2018 Mar;153(3):618-629. doi: 10.1016/j.chest.2017.11.016. Epub 2017 Nov 29.
PMID: 29197547
responsible party type: Sponsor
mesh term: Asthma
mesh term: Pulmonary Emphysema
mesh term: Emphysema
sharing ipd: Yes
ipd description: Results of tests
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: As indicated for collaborration
ipd access criteria: within 2 weeks of testing