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/NCT05976919</url>
    </required_header>
    <id_info>
      <org_study_id>323694</org_study_id>
      <nct_id>NCT05976919</nct_id>
    </id_info>
    <brief_title>Evaluating Treatable Traits Across the Spectrum of Chronic Obstructive Airways Disease</brief_title>
    <official_title>Evaluating Treatable Traits Across the Spectrum of Chronic Obstructive Airways Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Leeds</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The Leeds Teaching Hospitals NHS Trust</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Leeds</source>
    <oversight_info>
      <has_dmc>No</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>
        Respiratory disease affects one in five people and is a leading cause of global morbidity and&#xD;
        mortality. Chronic obstructive airways diseases encompass conditions characterised by&#xD;
        expiratory airflow limitation, exertional dyspnoea, activity limitation and impaired quality&#xD;
        of life. The most common conditions include chronic obstructive pulmonary disease (COPD),&#xD;
        asthma, bronchiectasis, cystic fibrosis and primary ciliary dyskinesia. In recent years,&#xD;
        there has been concerted effort in the scientific and respiratory medicine community to&#xD;
        improve the diagnosis and management of chronic obstructive airways diseases using&#xD;
        personalised or precision medicine (i.e., tailoring therapies and interventions according to&#xD;
        specific &quot;treatable traits&quot;) and identifying phenotypes or endotypes using validated&#xD;
        biomarkers. To date, however, research in this setting has primarily focussed on people with&#xD;
        COPD and asthma, with limited studies in other forms of chronic obstructive airways diseases.&#xD;
        The aim of this study is therefore two-fold; first, to compare pulmonary physiology (i.e.,&#xD;
        large and small airway involvement) and extra-pulmonary manifestations across the spectrum of&#xD;
        chronic obstructive airways, and second, to determine how disease-specific treatable traits&#xD;
        associate with physical activity and health-related quality of life.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2025</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Physical activity</measure>
      <time_frame>7 day period</time_frame>
      <description>Step-count</description>
    </primary_outcome>
    <number_of_groups>5</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Airway Disease</condition>
    <arm_group>
      <arm_group_label>COPD</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Asthma</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Bronchiectasis</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Cystic fibrosis</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Primary ciliary dyskinesia</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Pulmonary function testing</intervention_name>
      <description>Physiological assessment of pulmonary physiology (large and small airways), exercise capacity, physical activity and body composition.</description>
      <arm_group_label>Asthma</arm_group_label>
      <arm_group_label>Bronchiectasis</arm_group_label>
      <arm_group_label>COPD</arm_group_label>
      <arm_group_label>Cystic fibrosis</arm_group_label>
      <arm_group_label>Primary ciliary dyskinesia</arm_group_label>
      <other_name>Cardiopulmonary exercise testing</other_name>
      <other_name>Physical activity (daily step count)</other_name>
      <other_name>Dual-energy X-ray absorptiometry (body composition)</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Chronic obstructive airways disease&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Prior diagnosis of airways disease in accordance with European Respiratory Society&#xD;
               guidelines.&#xD;
  &#xD;
            -  Non / ex-smokers (packs recorded as cigarettes per day / years smoked).&#xD;
  &#xD;
            -  Male or female aged 18-65 years&#xD;
  &#xD;
            -  Ability to provide written informed consent.&#xD;
  &#xD;
            -  Full comprehension of spoken and written English language.&#xD;
  &#xD;
            -  Cystic Fibrosis patients on triple CFTR modulators (90% cohort)&#xD;
  &#xD;
            -  Cystic Fibrosis patients on no CFTR modulators&#xD;
  &#xD;
            -  Healthy controls - entirely asymptomatic, no prior history of inhaler medication use&#xD;
               and free from respiratory disease.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Severe exacerbation requiring hospital admission or oral corticosteroids (OCS) in the&#xD;
               past two months.&#xD;
  &#xD;
            -  Absolute or relative contraindications to cardio-pulmonary exercise testing or&#xD;
               submaximal exercise testing.&#xD;
  &#xD;
            -  Absolute or relative contraindications to pulmonary function testing .&#xD;
  &#xD;
            -  Absolute or relative contraindications to dual energy x-ray (DEXA) scanning (i.e.,&#xD;
               pregnancy, recent contrast media administration or subject weight).&#xD;
  &#xD;
            -  Non-ambulant or musculoskeletal impairment that may affect activities of daily living&#xD;
               or maximal exercise testing.&#xD;
  &#xD;
            -  Significant cognitive impairment (i.e., unable to provide written informed consent or&#xD;
               safely / successfully perform tests).&#xD;
  &#xD;
            -  Currently receiving oxygen therapy.&#xD;
  &#xD;
            -  Inability to consent.&#xD;
  &#xD;
            -  Burkholderia Cepacia Complex, mycobacterium tuberculosis or mycobacterium abseccus&#xD;
               infection.&#xD;
  &#xD;
            -  Lung transplantation&#xD;
  &#xD;
            -  Diagnosis of cardiovascular disease.&#xD;
  &#xD;
            -  Abnormal blood screening (anaemia, moderate / severe renal failure etc.)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Leeds</investigator_affiliation>
      <investigator_full_name>Dr Oliver Price</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, 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>
  
  
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/NCT05976919
  org study id: 323694
  nct id: NCT05976919
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Respiratory disease affects one in five people and is a leading cause of global morbidity and
        mortality. Chronic obstructive airways diseases encompass conditions characterised by
        expiratory airflow limitation, exertional dyspnoea, activity limitation and impaired quality
        of life. The most common conditions include chronic obstructive pulmonary disease (COPD),
        asthma, bronchiectasis, cystic fibrosis and primary ciliary dyskinesia. In recent years,
        there has been concerted effort in the scientific and respiratory medicine community to
        improve the diagnosis and management of chronic obstructive airways diseases using
        personalised or precision medicine (i.e., tailoring therapies and interventions according to
        specific "treatable traits") and identifying phenotypes or endotypes using validated
        biomarkers. To date, however, research in this setting has primarily focussed on people with
        COPD and asthma, with limited studies in other forms of chronic obstructive airways diseases.
        The aim of this study is therefore two-fold; first, to compare pulmonary physiology (i.e.,
        large and small airway involvement) and extra-pulmonary manifestations across the spectrum of
        chronic obstructive airways, and second, to determine how disease-specific treatable traits
        associate with physical activity and health-related quality of life.
  observational model: Cohort
  time perspective: Prospective
  measure: Physical activity
  time frame: 7 day period
  description: Step-count
  arm group label: COPD
  arm group label: Asthma
  arm group label: Bronchiectasis
  arm group label: Cystic fibrosis
  arm group label: Primary ciliary dyskinesia
  intervention type: Diagnostic Test
  intervention name: Pulmonary function testing
  description: Physiological assessment of pulmonary physiology (large and small airways), exercise capacity, physical activity and body composition.
  arm group label: Asthma
  arm group label: Bronchiectasis
  arm group label: COPD
  arm group label: Cystic fibrosis
  arm group label: Primary ciliary dyskinesia
  other name: Cardiopulmonary exercise testing
  other name: Physical activity (daily step count)
  other name: Dual-energy X-ray absorptiometry (body composition)
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  gender based: Yes
  minimum age: 18 Years
  maximum age: 65 Years
  responsible party type: Principal Investigator
  investigator affiliation: University of Leeds
  investigator full name: Dr Oliver Price
  investigator title: Principal Investigator
  mesh term: Lung Diseases, Obstructive
  mesh term: Pulmonary Disease, Chronic Obstructive
  sharing ipd: No