<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/NCT03795506</url>
  </required_header>
  <id_info>
    <org_study_id>18SM4747</org_study_id>
    <nct_id>NCT03795506</nct_id>
  </id_info>
  <brief_title>TLA in Children With Moderate to Severe Atopic Eczema (TLA4AE)</brief_title>
  <official_title>Temperature Controlled Laminar Airflow (TLA) Treatment of Moderate to Severe Atopic Eczema in Children and Adolescents - a Randomized Placebo Controlled Phase 2 Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>JP Moulton Charitable Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Imperial College London</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single centre randomised, placebo-controlled phase 2 study in which 96 children age&#xD;
      4 to 16 years with moderate to severe, longstanding allergic eczema will be enrolled.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following a 4 to 6 week period on standardised treatment (run-in period, to ensure everyone&#xD;
      starts with the same treatment approach), participants will be randomised to an active or&#xD;
      dummy temperature-controlled laminar airflow (TLA) device, which has been shown to markedly&#xD;
      reduce exposure to particles which can cause allergic reactions when being inhaled (inhaled&#xD;
      allergens) and other particles which are in the air the investigators breathe in. This has&#xD;
      been shown to be an effective treatment of atopic asthma.&#xD;
&#xD;
      The participants will undergo a 12-week treatment period. The device will then be removed and&#xD;
      a final follow-up visit occurs at 16 weeks. The total study duration, including the run-in&#xD;
      period is up to 22 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 8, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of eczema severity (Eczema Area Severity Index = EASI Score, total) at week 12 compared to baseline</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change of eczema severity (EASI Score) at week 12 compared to baseline; higher score = higher severity. range 0-72 (0=no eczema, 72 highest severity)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>(Eczema Area Severity Index = EASI): EASI 50, EASI 75</measure>
    <time_frame>12 weeks</time_frame>
    <description>Proportion of participants achieving at least a 50% (EASI 50) or 75% (EASI 75) reduction of eczema severity. EASI range 0-72 (0=no eczema, 72 highest severity)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SCORing Atopic Dermatitis = SCORAD Index</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in total SCORAD Index at week 12 compared to baseline; higher score = higher severity; range 0-103 (0=no eczema, 103 highest severity)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects achieving Investigator Global Assessment (IGA) of 0 or 1</measure>
    <time_frame>12 weeks</time_frame>
    <description>Proportion of subjects achieving Investigator Global Assessment (IGA) of 0 or 1; maximum score is 5 = most severe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in health related quality of life [QoL] from baseline for participants: CDQLI</measure>
    <time_frame>20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)</time_frame>
    <description>Change in health related quality of life during run-in period, 12 week treatment period and 4 weeks after treatment end using Children's Dermatitis Quality of Life Index (CDQLI). Range 0-30 (0=no QoL impairment, 30 severe QoL impairment)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of itch; Visual Analogue Score (VAS), from baseline</measure>
    <time_frame>20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)</time_frame>
    <description>Change of itch intensity during during run-in period, 12 week treatment period; and 4 weeks after treatment end; Visual Analogue Score (VAS) range 0-100; higher score = higher severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement of sleep; Visual Analogue Score (VAS), from baseline</measure>
    <time_frame>20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)</time_frame>
    <description>Change of sleep disturbance during run-in period, 12 week treatment period and 4 weeks after treatment end; Visual Analogue Score (VAS) range 0-100; higher score = higher severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in adverse impact on participants' families from baseline</measure>
    <time_frame>20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)</time_frame>
    <description>Change in adverse impact of participants' eczema on families,during run-in period, 12 week treatment period and 4 weeks after treatment end using Dermatitis Family Impact Questionnaire (DFI); higher score = worse impact. Range 0-30 (0=no impact, 30 severe adverse impact)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of patient reported eczema activity from baseline</measure>
    <time_frame>20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)</time_frame>
    <description>Change of patient reported eczema activity during run-in period, 12 week treatment period and 4 weeks after treatment end, using Patient Oriented Eczema Measure (POEM) tool; total score reported, higher score = higher severity; Range 0-28 (0=no impairment, 28 severe reported eczema symptoms)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in medication requirements (topical immunomodulators) from baseline</measure>
    <time_frame>20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)</time_frame>
    <description>Change in medication requirements during run-in period, 12 week treatment period and 4 weeks after treatment end (topical immunomodulators, topical steroids, topical calcineurin inhibitors) from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sleep quality from baseline: actigraphy</measure>
    <time_frame>4-6 weeks</time_frame>
    <description>Change in sleep quality, measured by actigraphy before and in first month after intervention start (total movement activity reported, higher scores = worse sleep disturbance); this is not a limited scale but simply counts the number of times an individual moves.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Atopic Dermatitis Eczema</condition>
  <arm_group>
    <arm_group_label>Active TLA Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 week overnight treatment with the active Temperature Controlled Laminar Airflow device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo TLA Device</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>12 week overnight treatment with the placebo Temperature Controlled Laminar Airflow device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nocturnal Temperature controlled Laminar Airflow (TLA) Treatment</intervention_name>
    <description>12 weeks of overnight treatment with active TLA device</description>
    <arm_group_label>Active TLA Device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Placebo TLA Device</intervention_name>
    <description>12 weeks of overnight use of placebo TLA device</description>
    <arm_group_label>Placebo TLA Device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 4 to 16 years at time of consent&#xD;
&#xD;
          -  Persistent moderate to severe eczema despite treatment with topical corticosteroids&#xD;
             (TCS) Class II or more and/or topical calcineurin inhibitors (TCI, licenced use only)&#xD;
             for at least 3 months.&#xD;
&#xD;
          -  Eczema Area and Severity Index (EASI) Score ≥12 at screening and randomisation visit&#xD;
             and &gt;10% body surface involved&#xD;
&#xD;
          -  Sensitisation to house dust mite species, confirmed by specific Immunoglobulin E&#xD;
             (ImmunoCAP ≥2) and/or Skin Prick Test (SPT ≥5mm)&#xD;
&#xD;
          -  Child able to sleep in their own bed and able to use the device for at least 5 out of&#xD;
             7 nights per week&#xD;
&#xD;
          -  Written, informed consent of parent/legal guardian and patient assent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  very severe atopic dermatitis&#xD;
&#xD;
          -  use of systemic immunosuppression (such as cyclosporine, methotrexate, azathioprine,&#xD;
             oral steroids) or UV therapy or extracorporal photopheresis within four weeks prior to&#xD;
             the screening visit&#xD;
&#xD;
          -  received therapeutic monoclonal antibodies (such as Omalizumab or Dupilumab) within&#xD;
             six months prior to the screening visit&#xD;
&#xD;
          -  Ongoing or planned desensitisation / immunotherapy during the study&#xD;
&#xD;
          -  Infections requiring systemic antimicrobial treatment within four weeks prior to the&#xD;
             screening visit&#xD;
&#xD;
          -  Introduction of special dietary restriction (for eczema treatment) within three months&#xD;
             prior to screening visit&#xD;
&#xD;
          -  Severe asthma ≥ Step 4 and/or ≥1 course of systemic oral steroids for asthma in the&#xD;
             three months prior to screening visit&#xD;
&#xD;
          -  Significant underlying chronic medical condition (chronic other skin disease,&#xD;
             inflammatory bowel disease, immunodeficiencies, other uncontrolled systemic disease,&#xD;
             cancer)&#xD;
&#xD;
          -  Planned time away from home (=unable to use TLA) exceeding 2 days/week; unable to use&#xD;
             the device at least 5/7 days in the 2-3 weeks prior to end of intervention period.&#xD;
&#xD;
          -  Prior research participation is not an exclusion criterion, except if it involved&#xD;
             eczema disease modifying agents.&#xD;
&#xD;
          -  Participating in current research&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claudia Gore, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Imperial College London</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Claudia Gore, MD PhD</last_name>
    <phone>+44 203 312 6650</phone>
    <email>cgore@nhs.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>IMPERIAL COLLEGE HEALTHCARE NHS Trust</name>
      <address>
        <city>London</city>
        <zip>W2 1NY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claudia Gore, PhD</last_name>
      <email>cgore@nhs.net</email>
    </contact>
    <investigator>
      <last_name>Claudia Gore, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Gore C, Gore RB, Fontanella S, Haider S, Custovic A. Temperature-controlled laminar airflow (TLA) device in the treatment of children with severe atopic eczema: Open-label, proof-of-concept study. Clin Exp Allergy. 2018 May;48(5):594-603. doi: 10.1111/cea.13105. Epub 2018 Mar 13.</citation>
    <PMID>29383776</PMID>
  </reference>
  <reference>
    <citation>Gore RB, Boyle RJ, Gore C, Custovic A, Hanna H, Svensson P, Warner JO. Effect of a novel temperature-controlled laminar airflow device on personal breathing zone aeroallergen exposure. Indoor Air. 2015 Feb;25(1):36-44. doi: 10.1111/ina.12122. Epub 2014 Jun 10.</citation>
    <PMID>24750266</PMID>
  </reference>
  <reference>
    <citation>Spilak MP, Sigsgaard T, Takai H, Zhang G. A Comparison between Temperature-Controlled Laminar Airflow Device and a Room Air-Cleaner in Reducing Exposure to Particles While Asleep. PLoS One. 2016 Nov 29;11(11):e0166882. doi: 10.1371/journal.pone.0166882. eCollection 2016.</citation>
    <PMID>27898693</PMID>
  </reference>
  <reference>
    <citation>Boyle RJ, Pedroletti C, Wickman M, Bjermer L, Valovirta E, Dahl R, Von Berg A, Zetterstrom O, Warner JO; 4A Study Group. Nocturnal temperature controlled laminar airflow for treating atopic asthma: a randomised controlled trial. Thorax. 2012 Mar;67(3):215-21. doi: 10.1136/thoraxjnl-2011-200665. Epub 2011 Nov 30.</citation>
    <PMID>22131290</PMID>
  </reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>September 22, 2022</last_update_submitted>
  <last_update_submitted_qc>September 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atopic Dermatitis Eczema</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03795506
org study id: 18SM4747
nct id: NCT03795506
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a single centre randomised, placebo-controlled phase 2 study in which 96 children age
      4 to 16 years with moderate to severe, longstanding allergic eczema will be enrolled.
Following a 4 to 6 week period on standardised treatment (run-in period, to ensure everyone
      starts with the same treatment approach), participants will be randomised to an active or
      dummy temperature-controlled laminar airflow (TLA) device, which has been shown to markedly
      reduce exposure to particles which can cause allergic reactions when being inhaled (inhaled
      allergens) and other particles which are in the air the investigators breathe in. This has
      been shown to be an effective treatment of atopic asthma.

      The participants will undergo a 12-week treatment period. The device will then be removed and
      a final follow-up visit occurs at 16 weeks. The total study duration, including the run-in
      period is up to 22 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change of eczema severity (Eczema Area Severity Index = EASI Score, total) at week 12 compared to baseline
time frame: 12 weeks
description: Change of eczema severity (EASI Score) at week 12 compared to baseline; higher score = higher severity. range 0-72 (0=no eczema, 72 highest severity)
measure: (Eczema Area Severity Index = EASI): EASI 50, EASI 75
time frame: 12 weeks
description: Proportion of participants achieving at least a 50% (EASI 50) or 75% (EASI 75) reduction of eczema severity. EASI range 0-72 (0=no eczema, 72 highest severity)
measure: Change in SCORing Atopic Dermatitis = SCORAD Index
time frame: 12 weeks
description: Change in total SCORAD Index at week 12 compared to baseline; higher score = higher severity; range 0-103 (0=no eczema, 103 highest severity)
measure: Proportion of subjects achieving Investigator Global Assessment (IGA) of 0 or 1
time frame: 12 weeks
description: Proportion of subjects achieving Investigator Global Assessment (IGA) of 0 or 1; maximum score is 5 = most severe
measure: Change in health related quality of life [QoL] from baseline for participants: CDQLI
time frame: 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
description: Change in health related quality of life during run-in period, 12 week treatment period and 4 weeks after treatment end using Children's Dermatitis Quality of Life Index (CDQLI). Range 0-30 (0=no QoL impairment, 30 severe QoL impairment)
measure: Improvement of itch; Visual Analogue Score (VAS), from baseline
time frame: 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
description: Change of itch intensity during during run-in period, 12 week treatment period; and 4 weeks after treatment end; Visual Analogue Score (VAS) range 0-100; higher score = higher severity
measure: Improvement of sleep; Visual Analogue Score (VAS), from baseline
time frame: 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
description: Change of sleep disturbance during run-in period, 12 week treatment period and 4 weeks after treatment end; Visual Analogue Score (VAS) range 0-100; higher score = higher severity
measure: Change in adverse impact on participants' families from baseline
time frame: 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
description: Change in adverse impact of participants' eczema on families,during run-in period, 12 week treatment period and 4 weeks after treatment end using Dermatitis Family Impact Questionnaire (DFI); higher score = worse impact. Range 0-30 (0=no impact, 30 severe adverse impact)
measure: Change of patient reported eczema activity from baseline
time frame: 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
description: Change of patient reported eczema activity during run-in period, 12 week treatment period and 4 weeks after treatment end, using Patient Oriented Eczema Measure (POEM) tool; total score reported, higher score = higher severity; Range 0-28 (0=no impairment, 28 severe reported eczema symptoms)
measure: Change in medication requirements (topical immunomodulators) from baseline
time frame: 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
description: Change in medication requirements during run-in period, 12 week treatment period and 4 weeks after treatment end (topical immunomodulators, topical steroids, topical calcineurin inhibitors) from baseline
measure: Change in sleep quality from baseline: actigraphy
time frame: 4-6 weeks
description: Change in sleep quality, measured by actigraphy before and in first month after intervention start (total movement activity reported, higher scores = worse sleep disturbance); this is not a limited scale but simply counts the number of times an individual moves.
arm group label: Active TLA Device
arm group type: Experimental
description: 12 week overnight treatment with the active Temperature Controlled Laminar Airflow device.
arm group label: Placebo TLA Device
arm group type: Placebo Comparator
description: 12 week overnight treatment with the placebo Temperature Controlled Laminar Airflow device.
intervention type: Device
intervention name: Nocturnal Temperature controlled Laminar Airflow (TLA) Treatment
description: 12 weeks of overnight treatment with active TLA device
arm group label: Active TLA Device
intervention type: Device
intervention name: Placebo TLA Device
description: 12 weeks of overnight use of placebo TLA device
arm group label: Placebo TLA Device
criteria: 
gender: All
minimum age: 4 Years
maximum age: 16 Years
healthy volunteers: No
last name: Claudia Gore, MD PhD
role: Principal Investigator
affiliation: Imperial College London
last name: Claudia Gore, MD PhD
phone: +44 203 312 6650
email: cgore@nhs.net
facility: 
status: Recruiting
contact: 
investigator: 
country: United Kingdom
citation: Gore C, Gore RB, Fontanella S, Haider S, Custovic A. Temperature-controlled laminar airflow (TLA) device in the treatment of children with severe atopic eczema: Open-label, proof-of-concept study. Clin Exp Allergy. 2018 May;48(5):594-603. doi: 10.1111/cea.13105. Epub 2018 Mar 13.
PMID: 29383776
citation: Gore RB, Boyle RJ, Gore C, Custovic A, Hanna H, Svensson P, Warner JO. Effect of a novel temperature-controlled laminar airflow device on personal breathing zone aeroallergen exposure. Indoor Air. 2015 Feb;25(1):36-44. doi: 10.1111/ina.12122. Epub 2014 Jun 10.
PMID: 24750266
citation: Spilak MP, Sigsgaard T, Takai H, Zhang G. A Comparison between Temperature-Controlled Laminar Airflow Device and a Room Air-Cleaner in Reducing Exposure to Particles While Asleep. PLoS One. 2016 Nov 29;11(11):e0166882. doi: 10.1371/journal.pone.0166882. eCollection 2016.
PMID: 27898693
citation: Boyle RJ, Pedroletti C, Wickman M, Bjermer L, Valovirta E, Dahl R, Von Berg A, Zetterstrom O, Warner JO; 4A Study Group. Nocturnal temperature controlled laminar airflow for treating atopic asthma: a randomised controlled trial. Thorax. 2012 Mar;67(3):215-21. doi: 10.1136/thoraxjnl-2011-200665. Epub 2011 Nov 30.
PMID: 22131290
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: No