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/NCT06029543</url>
    </required_header>
    <id_info>
      <org_study_id>WLHS2023001</org_study_id>
      <nct_id>NCT06029543</nct_id>
    </id_info>
    <brief_title>Permian Health Women's Lung Health Study</brief_title>
    <acronym>WLHS</acronym>
    <official_title>Permian Health Women's Lung Health Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Permian Health Lung Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The Gambia Committee on Traditional Practices Affecting the Health of Women and Children (GAMCOTRAP)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Permian Health Lung Institute</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>
        The goal of this cross-sectional observational study is to estimate the prevalence of lung&#xD;
        function impairment as measured by spirometry in a population of Gambian women aged 15 and&#xD;
        older. The main question[s] it aims to answer are:&#xD;
  &#xD;
          -  What is the prevalence of lung function impairment in Gambian women&#xD;
  &#xD;
          -  What is the prevalence of eosinophilic inflammation in Gambian women&#xD;
  &#xD;
        Consenting participants will undergo&#xD;
  &#xD;
          -  Spirometry&#xD;
  &#xD;
          -  Fractional exhaled nitric oxide (FENO) testing&#xD;
  &#xD;
          -  α1-antitrypsin testing in patients with lung function impairment as assessed by&#xD;
             spirometry&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 2023</start_date>
    <completion_date type="Anticipated">December 2026</completion_date>
    <primary_completion_date type="Anticipated">December 2026</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Ecologic or Community</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <target_duration>3 Years</target_duration>
    <primary_outcome>
      <measure>Prevalence of lung function Impairment as measured by spirometry</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Certified technicians will perform Spirometry testing to measure lung function parameters such as FEV1, FVC, and FEV1/FVC ratio. Results will be interpreted by two Pulmonologists using GLI reference equations and z-scores. Bronchodilator reversibility is defined as an improvement of over 10% in FEV1 after albuterol sulfate administration. Lung function impairment will be assessed based on z-scores, with normal lung function being z-scores greater than -1.645, mild impairment between -1.65 and -2.5, moderate impairment between -2.51 and -4, and severe impairment below -4.1.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Prevalence of Type II (Eosinophilic) inflammation in Gambian Women</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>FENO measurements will be taken using handheld devices called NIOX VERO. These devices are compliant with guidelines set by the American Thoracic Society and European Respiratory Society. To measure FENO, participants will be instructed to exhale into the device through a filtered mouthpiece. The exhaling process will be regulated to maintain a controlled flow rate and pressure for a duration of 10 seconds.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">350</enrollment>
    <condition>COPD</condition>
    <condition>Lung Function Decreased</condition>
    <condition>Alpha 1-Antitrypsin</condition>
    <arm_group>
      <arm_group_label>Gambian Women</arm_group_label>
      <description>Gambian women aged 15 and older with lung function impairment as measured by spirometry</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          All women older than 15 years in The Gambia&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
            -  Self-identified female sex&#xD;
  &#xD;
            -  Age &gt; 15 years: This age cutoff was chosen (as opposed to 18) because of the unique&#xD;
               cultural norms and practices in the country where experiences and exposures occur at&#xD;
               an earlier age than women in Western countries.&#xD;
  &#xD;
          Exclusion criteria:&#xD;
  &#xD;
            -  Age &lt; 15 years&#xD;
  &#xD;
            -  Non-resident household member&#xD;
  &#xD;
            -  Any acutely unwell individual&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Any known history of active pulmonary disease (including TB) on treatment.&#xD;
  &#xD;
            -  Individuals unable or unwilling to give consent.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Self-identified female sex</gender_description>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Gamcotrap</name>
        <address>
          <city>Kanifing</city>
          <country>Gambia</country>
        </address>
      </facility>
      <contact>
        <last_name>Musa D Jallow</last_name>
        <phone>+220-712-0569</phone>
        <email>musajah1979@yahoo.com</email>
      </contact>
      <contact_backup>
        <last_name>Adjoa K Hackman-Stevens</last_name>
        <phone>+220-219-4022</phone>
        <email>nanarays12@gmail.com</email>
      </contact_backup>
      <investigator>
        <last_name>Isatou Touray, DPhil</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Sunkaru Touray, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Gambia</country>
    </location_countries>
    <reference>
      <citation>Ale BM, Ozoh OB, Gadanya MA, Li Y, Harhay MO, Adebiyi AO, Adeloye D. Estimating the prevalence of COPD in an African country: evidence from southern Nigeria. J Glob Health Rep. 2022;6:e2022049. doi: 10.29392/001c.38200. Epub 2022 Sep 15.</citation>
      <PMID>36185970</PMID>
    </reference>
    <reference>
      <citation>Chan-Yeung M, Ait-Khaled N, White N, Ip MS, Tan WC. The burden and impact of COPD in Asia and Africa. Int J Tuberc Lung Dis. 2004 Jan;8(1):2-14.</citation>
      <PMID>14974740</PMID>
    </reference>
    <reference>
      <citation>Halbert RJ, Natoli JL, Gano A, Badamgarav E, Buist AS, Mannino DM. Global burden of COPD: systematic review and meta-analysis. Eur Respir J. 2006 Sep;28(3):523-32. doi: 10.1183/09031936.06.00124605. Epub 2006 Apr 12.</citation>
      <PMID>16611654</PMID>
    </reference>
    <reference>
      <citation>Stoller JK, Sandhaus RA, Turino G, Dickson R, Rodgers K, Strange C. Delay in diagnosis of alpha1-antitrypsin deficiency: a continuing problem. Chest. 2005 Oct;128(4):1989-94. doi: 10.1378/chest.128.4.1989.</citation>
      <PMID>16236846</PMID>
    </reference>
    <reference>
      <citation>Chapman KR, Chorostowska-Wynimko J, Koczulla AR, Ferrarotti I, McElvaney NG. Alpha 1 antitrypsin to treat lung disease in alpha 1 antitrypsin deficiency: recent developments and clinical implications. Int J Chron Obstruct Pulmon Dis. 2018 Jan 31;13:419-432. doi: 10.2147/COPD.S149429. eCollection 2018.</citation>
      <PMID>29430176</PMID>
    </reference>
    <reference>
      <citation>American Thoracic Society; European Respiratory Society. American Thoracic Society/European Respiratory Society statement: standards for the diagnosis and management of individuals with alpha-1 antitrypsin deficiency. Am J Respir Crit Care Med. 2003 Oct 1;168(7):818-900. doi: 10.1164/rccm.168.7.818. No abstract available.</citation>
      <PMID>14522813</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Alpha 1-Antitrypsin Deficiency</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/NCT06029543
  org study id: WLHS2023001
  nct id: NCT06029543
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this cross-sectional observational study is to estimate the prevalence of lung
        function impairment as measured by spirometry in a population of Gambian women aged 15 and
        older. The main question[s] it aims to answer are:
  
          -  What is the prevalence of lung function impairment in Gambian women
  
          -  What is the prevalence of eosinophilic inflammation in Gambian women
  
        Consenting participants will undergo
  
          -  Spirometry
  
          -  Fractional exhaled nitric oxide (FENO) testing
  
          -  α1-antitrypsin testing in patients with lung function impairment as assessed by
             spirometry
  observational model: Ecologic or Community
  time perspective: Cross-Sectional
  measure: Prevalence of lung function Impairment as measured by spirometry
  time frame: Through study completion, an average of 1 year
  description: Certified technicians will perform Spirometry testing to measure lung function parameters such as FEV1, FVC, and FEV1/FVC ratio. Results will be interpreted by two Pulmonologists using GLI reference equations and z-scores. Bronchodilator reversibility is defined as an improvement of over 10% in FEV1 after albuterol sulfate administration. Lung function impairment will be assessed based on z-scores, with normal lung function being z-scores greater than -1.645, mild impairment between -1.65 and -2.5, moderate impairment between -2.51 and -4, and severe impairment below -4.1.
  measure: Prevalence of Type II (Eosinophilic) inflammation in Gambian Women
  time frame: Through study completion, an average of 1 year
  description: FENO measurements will be taken using handheld devices called NIOX VERO. These devices are compliant with guidelines set by the American Thoracic Society and European Respiratory Society. To measure FENO, participants will be instructed to exhale into the device through a filtered mouthpiece. The exhaling process will be regulated to maintain a controlled flow rate and pressure for a duration of 10 seconds.
  arm group label: Gambian Women
  description: Gambian women aged 15 and older with lung function impairment as measured by spirometry
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Self-identified female sex
  minimum age: 15 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: Gambia
  citation: Ale BM, Ozoh OB, Gadanya MA, Li Y, Harhay MO, Adebiyi AO, Adeloye D. Estimating the prevalence of COPD in an African country: evidence from southern Nigeria. J Glob Health Rep. 2022;6:e2022049. doi: 10.29392/001c.38200. Epub 2022 Sep 15.
  PMID: 36185970
  citation: Chan-Yeung M, Ait-Khaled N, White N, Ip MS, Tan WC. The burden and impact of COPD in Asia and Africa. Int J Tuberc Lung Dis. 2004 Jan;8(1):2-14.
  PMID: 14974740
  citation: Halbert RJ, Natoli JL, Gano A, Badamgarav E, Buist AS, Mannino DM. Global burden of COPD: systematic review and meta-analysis. Eur Respir J. 2006 Sep;28(3):523-32. doi: 10.1183/09031936.06.00124605. Epub 2006 Apr 12.
  PMID: 16611654
  citation: Stoller JK, Sandhaus RA, Turino G, Dickson R, Rodgers K, Strange C. Delay in diagnosis of alpha1-antitrypsin deficiency: a continuing problem. Chest. 2005 Oct;128(4):1989-94. doi: 10.1378/chest.128.4.1989.
  PMID: 16236846
  citation: Chapman KR, Chorostowska-Wynimko J, Koczulla AR, Ferrarotti I, McElvaney NG. Alpha 1 antitrypsin to treat lung disease in alpha 1 antitrypsin deficiency: recent developments and clinical implications. Int J Chron Obstruct Pulmon Dis. 2018 Jan 31;13:419-432. doi: 10.2147/COPD.S149429. eCollection 2018.
  PMID: 29430176
  citation: American Thoracic Society; European Respiratory Society. American Thoracic Society/European Respiratory Society statement: standards for the diagnosis and management of individuals with alpha-1 antitrypsin deficiency. Am J Respir Crit Care Med. 2003 Oct 1;168(7):818-900. doi: 10.1164/rccm.168.7.818. No abstract available.
  PMID: 14522813
  responsible party type: Sponsor
  mesh term: Alpha 1-Antitrypsin Deficiency
  sharing ipd: No