<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/NCT04407598</url>
  </required_header>
  <id_info>
    <org_study_id>0778</org_study_id>
    <nct_id>NCT04407598</nct_id>
  </id_info>
  <brief_title>COPD in the Time of COVID-19</brief_title>
  <official_title>Cross-Sectional Observation Telephone Survey Study to Understand the Changes in COPD Exacerbation Patterns and Potential Causes of These During the COVID-19 Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Leicester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospitals, Leicester</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Leicester</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>
      This cross-sectional observational study will collect information about changes in&#xD;
      exacerbation frequency and behaviour amongst a clinical cohort of severe or complex COPD&#xD;
      clinic patients. This will be done through a combination of telephone survey and access to&#xD;
      electronic heath records.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a cross-sectional observational study utilising a telephone survey.&#xD;
&#xD;
      After obtaining informed verbal consent participants will be asked to recall their symptoms,&#xD;
      exacerbation events and exacerbation medication usage over the periods of 01/03/20 - 14/03/20&#xD;
      (pre-lockdown) and then 15/03/20 to 30/04/20 (lockdown).&#xD;
&#xD;
      A structured survey will follow on from this asking questions regarding behaviour including&#xD;
      self-isolation, shielding, other household contacts, visitors to the home, arrangements for&#xD;
      shopping, changes in smoking behaviour (including that of other smokers in the household),&#xD;
      medication changes, self-reported change in use of preventer medication, self-reported change&#xD;
      in walking/activity levels and self-reported changes in anxiety levels.&#xD;
&#xD;
      Baseline clinical data will subsequently also be collected from the comprehensive respiratory&#xD;
      review previously performed in the complex COPD clinic (comprising both hospital and GP&#xD;
      records.) This will include previous AECOPD phenotyping (eosinophil levels, sputum culture&#xD;
      and viral PCR), previous lung function testing, prescribed medication, BMI and smoking status&#xD;
      and history. Previous AECOPD events will be counted and graded based on GP antibiotic or&#xD;
      steroid prescriptions and hospital admissions.&#xD;
&#xD;
      Participants will be contacted once as part of the main study following verbal informed&#xD;
      consent (via telephone). This will be a brief survey as described above, lasting&#xD;
      approximately 20 minutes. A second similar survey will take place up to 12 months after the&#xD;
      initial contact to evaluate longitudinal changes associated with the lockdown (further&#xD;
      details on this will be submitted as an amendment at a later date due the shifting and&#xD;
      unpredictable nature of the COVID-19 pandemic and lockdown, this will be prior to initiating&#xD;
      these second calls).&#xD;
&#xD;
      Additional clinical data will be collected from healthcare records to quantify disease&#xD;
      severity. Participant postcodes will be collected to link results with changes in local air&#xD;
      pollution as recorded or estimated during the COVID-19 lockdown.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 1, 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Actual">June 8, 2020</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in COPD Exacerbation Rate</measure>
    <time_frame>46 days</time_frame>
    <description>The primary outcome will be the change in number of moderate or severe AECOPD events over the 46 days from the 15th March, 2020 to 30th April, 2020 compared to the same 46 day period in 2019.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in number of Severe AECOPD events during period of interest in 2020 from same period in 2019.</measure>
    <time_frame>46 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Moderate AECOPD events during period of interest in 2020 from same period in 2019.</measure>
    <time_frame>46 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social contact changes during i) pre-lockdown and ii) lockdown period</measure>
    <time_frame>46 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Household contacts during i) pre-lockdown and ii) lockdown period</measure>
    <time_frame>46 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Household visitors during i) pre-lockdown and ii) lockdown period</measure>
    <time_frame>46 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regular shopping behaviour during i) pre-lockdown and ii) lockdown period</measure>
    <time_frame>46 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication changes during i) pre-lockdown and ii) lockdown period</measure>
    <time_frame>46 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reported change in regular medication usage during i) pre-lockdown and ii) lockdown period</measure>
    <time_frame>46 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical activity levels during i) pre-lockdown and ii) lockdown period</measure>
    <time_frame>46 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anxiety levels during i) pre-lockdown and ii) lockdown period</measure>
    <time_frame>46 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived fear of hospitalisation during COVID-19 period</measure>
    <time_frame>46 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient reported changes in perception of symptoms, need for hospitalisation and availability and safety of healthcare resources thought semi-structured interviews in 20 patients (nested qualitative study)</measure>
    <time_frame>46 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between changes in AECOPD event rate and changes in local air pollution during the COVID-19 lockdown</measure>
    <time_frame>46 days</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">160</enrollment>
  <condition>COPD Exacerbation</condition>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>Glenfield Complex COPD Clinic Cohort</arm_group_label>
    <description>Patients previously seen in the complex COPD clinic at the Glenfield Hospital.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients known to have COPD and previously seen in the Complex COPD Clinic at the Glenfield&#xD;
        Hospital, Leicester.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Confirmed clinical diagnosis of COPD&#xD;
&#xD;
          2. Ability to provide informed verbal consent via English language telephone consultation&#xD;
&#xD;
          3. Adults aged over 40 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients currently admitted to hospital&#xD;
&#xD;
          2. Unwilling/unable to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neil J Greening, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Leicester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NIHR Leicester Biomedical Research Centre (Respiratory), Glenfield Hospital</name>
      <address>
        <city>Leicester</city>
        <zip>LE3 9QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>AECOPD</keyword>
  <keyword>COVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>September 28, 2021</submitted>
    <returned>September 30, 2021</returned>
    <submitted>November 1, 2022</submitted>
    <returned>September 11, 2023</returned>
  </pending_results>
  <!-- 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/NCT04407598
org study id: 0778
nct id: NCT04407598
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This cross-sectional observational study will collect information about changes in
      exacerbation frequency and behaviour amongst a clinical cohort of severe or complex COPD
      clinic patients. This will be done through a combination of telephone survey and access to
      electronic heath records.
This study will be a cross-sectional observational study utilising a telephone survey.

      After obtaining informed verbal consent participants will be asked to recall their symptoms,
      exacerbation events and exacerbation medication usage over the periods of 01/03/20 - 14/03/20
      (pre-lockdown) and then 15/03/20 to 30/04/20 (lockdown).

      A structured survey will follow on from this asking questions regarding behaviour including
      self-isolation, shielding, other household contacts, visitors to the home, arrangements for
      shopping, changes in smoking behaviour (including that of other smokers in the household),
      medication changes, self-reported change in use of preventer medication, self-reported change
      in walking/activity levels and self-reported changes in anxiety levels.

      Baseline clinical data will subsequently also be collected from the comprehensive respiratory
      review previously performed in the complex COPD clinic (comprising both hospital and GP
      records.) This will include previous AECOPD phenotyping (eosinophil levels, sputum culture
      and viral PCR), previous lung function testing, prescribed medication, BMI and smoking status
      and history. Previous AECOPD events will be counted and graded based on GP antibiotic or
      steroid prescriptions and hospital admissions.

      Participants will be contacted once as part of the main study following verbal informed
      consent (via telephone). This will be a brief survey as described above, lasting
      approximately 20 minutes. A second similar survey will take place up to 12 months after the
      initial contact to evaluate longitudinal changes associated with the lockdown (further
      details on this will be submitted as an amendment at a later date due the shifting and
      unpredictable nature of the COVID-19 pandemic and lockdown, this will be prior to initiating
      these second calls).

      Additional clinical data will be collected from healthcare records to quantify disease
      severity. Participant postcodes will be collected to link results with changes in local air
      pollution as recorded or estimated during the COVID-19 lockdown.
observational model: Cohort
time perspective: Cross-Sectional
measure: Change in COPD Exacerbation Rate
time frame: 46 days
description: The primary outcome will be the change in number of moderate or severe AECOPD events over the 46 days from the 15th March, 2020 to 30th April, 2020 compared to the same 46 day period in 2019.
measure: Change in number of Severe AECOPD events during period of interest in 2020 from same period in 2019.
time frame: 46 days
measure: Change in Moderate AECOPD events during period of interest in 2020 from same period in 2019.
time frame: 46 days
measure: Social contact changes during i) pre-lockdown and ii) lockdown period
time frame: 46 days
measure: Household contacts during i) pre-lockdown and ii) lockdown period
time frame: 46 days
measure: Household visitors during i) pre-lockdown and ii) lockdown period
time frame: 46 days
measure: Regular shopping behaviour during i) pre-lockdown and ii) lockdown period
time frame: 46 days
measure: Medication changes during i) pre-lockdown and ii) lockdown period
time frame: 46 days
measure: Reported change in regular medication usage during i) pre-lockdown and ii) lockdown period
time frame: 46 days
measure: Change in physical activity levels during i) pre-lockdown and ii) lockdown period
time frame: 46 days
measure: Change in anxiety levels during i) pre-lockdown and ii) lockdown period
time frame: 46 days
measure: Perceived fear of hospitalisation during COVID-19 period
time frame: 46 days
measure: Patient reported changes in perception of symptoms, need for hospitalisation and availability and safety of healthcare resources thought semi-structured interviews in 20 patients (nested qualitative study)
time frame: 46 days
measure: Association between changes in AECOPD event rate and changes in local air pollution during the COVID-19 lockdown
time frame: 46 days
arm group label: Glenfield Complex COPD Clinic Cohort
description: Patients previously seen in the complex COPD clinic at the Glenfield Hospital.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Neil J Greening, PhD
role: Principal Investigator
affiliation: University of Leicester
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No
submitted: September 28, 2021
returned: September 30, 2021
submitted: November 1, 2022
returned: September 11, 2023