<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/NCT02977078</url>
  </required_header>
  <id_info>
    <org_study_id>14RM008</org_study_id>
    <secondary_id>193750</secondary_id>
    <nct_id>NCT02977078</nct_id>
  </id_info>
  <brief_title>Improving Asthma Treatment Using Inhaler Technology</brief_title>
  <official_title>Improving Asthma Treatment Using Inhaler Technology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nottingham University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Nottingham University Hospitals NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will use inhaler technology to observe and feedback overall patterns of medication&#xD;
      use. We will look at whether this improves preventer inhaler use and reduces reliever inhaler&#xD;
      overuse.&#xD;
&#xD;
      We will also assess whether inhaler technology is patient-friendly and cost effective,&#xD;
      whether it helps with treatment decisions in asthma and whether it can help us to predict and&#xD;
      prevent asthma attacks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The SmartTouch™ range of electronic casings will record the use of metered dose inhalers&#xD;
      (MDI) by participants in the study. The actuation data can be remotely viewed and analyzed by&#xD;
      the investigators.&#xD;
&#xD;
      The hypothesis is that employing such technology to measure medication patterns and to help&#xD;
      provide patient feedback improves inhaler adherence and potentially clinical outcomes (asthma&#xD;
      control and exacerbations) in asthma patients with recent asthma attacks in a practical,&#xD;
      real-world setting.&#xD;
&#xD;
      We will assess whether electronic inhaler data capture can identify patients requiring more&#xD;
      frequent reviews or treatment change and enable proactive self- management.&#xD;
&#xD;
      Using qualitative methods, we will explore participants' attitudes to their asthma&#xD;
      management, whether the use of inhaler technology has had an impact on this and whether they&#xD;
      found its use acceptable.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">April 2018</completion_date>
  <primary_completion_date type="Anticipated">April 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Impact on adherence to preventative medication use based on the mean percentage of prescribed doses taken daily over the study period</measure>
    <time_frame>Upto 24 weeks (study duration)</time_frame>
    <description>Co-primary endpoint</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact on adherence to reliever medication use based on the number of days with &gt;16 actuations/day of Salbutamol taken in a 24-hour period</measure>
    <time_frame>Upto 24 weeks (study duration)</time_frame>
    <description>Co-primary endpoint</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient acceptability via qualitative feedback with questionnaires</measure>
    <time_frame>Upto 24 weeks (study duration)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Inhaler use monitored by device but no feedback to participants (control); this group is unaware of the second arm receiving feedback on inhaler use.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inhaler use monitored with feedback to participants (active); participants randomized to this group sign an additional consent to receive feedback on inhaler use</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active feedback on monitored inhaler use</intervention_name>
    <description>Feedback given on inhaler use by research nurse/ doctor based on mobile application feedback</description>
    <arm_group_label>Active</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Inhaler casing</intervention_name>
    <description>Monitors inhaler use</description>
    <arm_group_label>Active</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mobile application</intervention_name>
    <description>Mobile application software linked to inhaler casing</description>
    <arm_group_label>Active</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Use of systemic corticosteroids for worsening asthma (or an increase from baseline&#xD;
             dose in patients on long-term oral corticosteroids) in the prior 12 months [i.e. at&#xD;
             least one asthma exacerbation requiring additional systemic corticosteroid in the&#xD;
             prior 12 months] patient reported.&#xD;
&#xD;
          -  Doctor's diagnosis of asthma for at least 12 months&#xD;
&#xD;
          -  On BTS step 2-5 treatment via MDI [monitoring devices to be utilised in the study are&#xD;
             compatible with MDI inhalers]&#xD;
&#xD;
          -  Use of own internet-enabled and compatible mobile phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of COPD or onset of symptoms after the age of 40 in patients with ≥10 Pack&#xD;
             Year History of smoking&#xD;
&#xD;
          -  Other clinically significant coexisting respiratory disease e.g. fibrosis,&#xD;
             bronchiectasis&#xD;
&#xD;
          -  Patients on maintenance and reliever therapy ('SMART' or 'Fostair® MART')&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dominick Shaw</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nottingham</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dominick Shaw</last_name>
    <email>Dominic.Shaw@nottingham.ac.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maria Koufali</last_name>
    <email>researchsponsor@nuh.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nottingham University Hospitals NHS Trust, Queens Medical Centre Campus</name>
      <address>
        <city>Nottingham</city>
        <state>Nottinghamshire</state>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ireti Adejumo</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Inhaler</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share IPD</ipd_description>
  </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/NCT02977078
org study id: 14RM008
secondary id: 193750
nct id: NCT02977078
lead sponsor: 
collaborator: 
has dmc: No
This study will use inhaler technology to observe and feedback overall patterns of medication
      use. We will look at whether this improves preventer inhaler use and reduces reliever inhaler
      overuse.

      We will also assess whether inhaler technology is patient-friendly and cost effective,
      whether it helps with treatment decisions in asthma and whether it can help us to predict and
      prevent asthma attacks.
The SmartTouch™ range of electronic casings will record the use of metered dose inhalers
      (MDI) by participants in the study. The actuation data can be remotely viewed and analyzed by
      the investigators.

      The hypothesis is that employing such technology to measure medication patterns and to help
      provide patient feedback improves inhaler adherence and potentially clinical outcomes (asthma
      control and exacerbations) in asthma patients with recent asthma attacks in a practical,
      real-world setting.

      We will assess whether electronic inhaler data capture can identify patients requiring more
      frequent reviews or treatment change and enable proactive self- management.

      Using qualitative methods, we will explore participants' attitudes to their asthma
      management, whether the use of inhaler technology has had an impact on this and whether they
      found its use acceptable.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Impact on adherence to preventative medication use based on the mean percentage of prescribed doses taken daily over the study period
time frame: Upto 24 weeks (study duration)
description: Co-primary endpoint
measure: Impact on adherence to reliever medication use based on the number of days with >16 actuations/day of Salbutamol taken in a 24-hour period
time frame: Upto 24 weeks (study duration)
description: Co-primary endpoint
measure: Patient acceptability via qualitative feedback with questionnaires
time frame: Upto 24 weeks (study duration)
arm group label: Control
arm group type: Sham Comparator
description: Inhaler use monitored by device but no feedback to participants (control); this group is unaware of the second arm receiving feedback on inhaler use.
arm group label: Active
arm group type: Experimental
description: Inhaler use monitored with feedback to participants (active); participants randomized to this group sign an additional consent to receive feedback on inhaler use
intervention type: Behavioral
intervention name: Active feedback on monitored inhaler use
description: Feedback given on inhaler use by research nurse/ doctor based on mobile application feedback
arm group label: Active
intervention type: Device
intervention name: Inhaler casing
description: Monitors inhaler use
arm group label: Active
arm group label: Control
intervention type: Device
intervention name: Mobile application
description: Mobile application software linked to inhaler casing
arm group label: Active
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Dominick Shaw
role: Principal Investigator
affiliation: University of Nottingham
last name: Dominick Shaw
email: Dominic.Shaw@nottingham.ac.uk
last name: Maria Koufali
email: researchsponsor@nuh.nhs.uk
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No
ipd description: No plan to share IPD