<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/NCT04410120</url>
  </required_header>
  <id_info>
    <org_study_id>20038</org_study_id>
    <nct_id>NCT04410120</nct_id>
  </id_info>
  <brief_title>Impact of Asthma Exacerbations</brief_title>
  <acronym>IMPAX</acronym>
  <official_title>Impact of Asthma Exacerbations: A Qualitative Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nottingham</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 purpose of the study is to gain a deeper understanding of the impact of asthma attacks on&#xD;
      the lives of patients who experience them. This will help us to describe the true extent of&#xD;
      the impact of asthma attacks on factors of importance to patients which have not previously&#xD;
      been well described, including the psychological, social, financial and emotional burden of&#xD;
      asthma attacks.&#xD;
&#xD;
      Additionally, it is hoped that detailed questioning regarding features of asthma attacks from&#xD;
      a patient perspective will improve our understanding of patient recognition of attacks,&#xD;
      consistency of certain features of attacks and patient views regarding preventative&#xD;
      strategies for attacks. Patient experiences of asthma attacks are poorly described in&#xD;
      previous research. Hence this work is expected to provide useful insights into these&#xD;
      experiences which will contribute to improvements in detecting, treating and preventing&#xD;
      asthma attacks.&#xD;
&#xD;
      The study will consist of a one-off interview lasting about 45 minutes with patients who have&#xD;
      recently had asthma attacks. We plan to recruit patients for the study from an outpatient&#xD;
      clinic for those who have had a recent attack or from a register of patients who have&#xD;
      volunteered for future asthma research studies. The interviews will take place in person at&#xD;
      the Respiratory Research Unit at the Nottingham City Hospital or over the telephone depending&#xD;
      on patient preference.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Thematic analysis of interview transcripts using framework approach</measure>
    <time_frame>One off 45 minute interview</time_frame>
    <description>Thematic analysis of interview transcripts using framework approach</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Asthma Attack</condition>
  <arm_group>
    <arm_group_label>Asthma with recent (&lt;4/52) asthma attack</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interview</intervention_name>
    <description>Semi-structured 45 minute interviews regarding impact of asthma attacks</description>
    <arm_group_label>Asthma with recent (&lt;4/52) asthma attack</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with previous clinician diagnosis of asthma who have had a recent (≤4 weeks) asthma&#xD;
        attack for which they received ≥3 days of systemic corticosteroid treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults with previous clinician diagnosis of asthma (16 years and above)&#xD;
&#xD;
          -  Recent (≤4 weeks) asthma attack for which patient received ≥3 days of systemic&#xD;
             corticosteroid treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anyone under the age of 16 years.&#xD;
&#xD;
          -  Anyone unable to speak or understand English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Nottingham Respiratory Research Unit</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG5 1PB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <contact>
      <last_name>Matthew J Martin, PhD, MBChB</last_name>
      <email>matthew.martin@nottingham.ac.uk</email>
    </contact>
    <investigator>
      <last_name>Matthew J Martin, PhD, MBChB</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Manpreet Bains, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</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>Asthma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04410120
org study id: 20038
nct id: NCT04410120
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to gain a deeper understanding of the impact of asthma attacks on
      the lives of patients who experience them. This will help us to describe the true extent of
      the impact of asthma attacks on factors of importance to patients which have not previously
      been well described, including the psychological, social, financial and emotional burden of
      asthma attacks.

      Additionally, it is hoped that detailed questioning regarding features of asthma attacks from
      a patient perspective will improve our understanding of patient recognition of attacks,
      consistency of certain features of attacks and patient views regarding preventative
      strategies for attacks. Patient experiences of asthma attacks are poorly described in
      previous research. Hence this work is expected to provide useful insights into these
      experiences which will contribute to improvements in detecting, treating and preventing
      asthma attacks.

      The study will consist of a one-off interview lasting about 45 minutes with patients who have
      recently had asthma attacks. We plan to recruit patients for the study from an outpatient
      clinic for those who have had a recent attack or from a register of patients who have
      volunteered for future asthma research studies. The interviews will take place in person at
      the Respiratory Research Unit at the Nottingham City Hospital or over the telephone depending
      on patient preference.
observational model: Other
time perspective: Prospective
measure: Thematic analysis of interview transcripts using framework approach
time frame: One off 45 minute interview
description: Thematic analysis of interview transcripts using framework approach
arm group label: Asthma with recent (<4/52) asthma attack
intervention type: Other
intervention name: Interview
description: Semi-structured 45 minute interviews regarding impact of asthma attacks
arm group label: Asthma with recent (<4/52) asthma attack
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
facility: 
contact: 
investigator: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: Undecided