Back to resultsTLA in Children With Moderate to Severe Atopic Eczema (TLA4AE)
Primary Purpose
Atopic Dermatitis Eczema
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Nocturnal Temperature controlled Laminar Airflow (TLA) Treatment
Placebo TLA Device
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis Eczema focused on measuring Atopic Dermatitis Eczema
Eligibility Criteria
Inclusion Criteria:
- Age 4 to 16 years at time of consent
- Persistent moderate to severe eczema despite treatment with topical corticosteroids (TCS) Class II or more and/or topical calcineurin inhibitors (TCI, licenced use only) for at least 3 months.
- Eczema Area and Severity Index (EASI) Score ≥12 at screening and randomisation visit and >10% body surface involved
- Sensitisation to house dust mite species, confirmed by specific Immunoglobulin E (ImmunoCAP ≥2) and/or Skin Prick Test (SPT ≥5mm)
- Child able to sleep in their own bed and able to use the device for at least 5 out of 7 nights per week
- Written, informed consent of parent/legal guardian and patient assent
Exclusion Criteria:
- very severe atopic dermatitis
- use of systemic immunosuppression (such as cyclosporine, methotrexate, azathioprine, oral steroids) or UV therapy or extracorporal photopheresis within four weeks prior to the screening visit
- received therapeutic monoclonal antibodies (such as Omalizumab or Dupilumab) within six months prior to the screening visit
- Ongoing or planned desensitisation / immunotherapy during the study
- Infections requiring systemic antimicrobial treatment within four weeks prior to the screening visit
- Introduction of special dietary restriction (for eczema treatment) within three months prior to screening visit
- Severe asthma ≥ Step 4 and/or ≥1 course of systemic oral steroids for asthma in the three months prior to screening visit
- Significant underlying chronic medical condition (chronic other skin disease, inflammatory bowel disease, immunodeficiencies, other uncontrolled systemic disease, cancer)
- Planned time away from home (=unable to use TLA) exceeding 2 days/week; unable to use the device at least 5/7 days in the 2-3 weeks prior to end of intervention period.
- Prior research participation is not an exclusion criterion, except if it involved eczema disease modifying agents.
- Participating in current research
Sites / Locations
- IMPERIAL COLLEGE HEALTHCARE NHS TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active TLA Device
Placebo TLA Device
Arm Description
12 week overnight treatment with the active Temperature Controlled Laminar Airflow device.
12 week overnight treatment with the placebo Temperature Controlled Laminar Airflow device.
Outcomes
Primary Outcome Measures
Change of eczema severity (Eczema Area Severity Index = EASI Score, total) at week 12 compared to baseline
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)
Secondary Outcome Measures
(Eczema Area Severity Index = EASI): EASI 50, EASI 75
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)
Change in SCORing Atopic Dermatitis = SCORAD Index
Change in total SCORAD Index at week 12 compared to baseline; higher score = higher severity; range 0-103 (0=no eczema, 103 highest severity)
Proportion of subjects achieving Investigator Global Assessment (IGA) of 0 or 1
Proportion of subjects achieving Investigator Global Assessment (IGA) of 0 or 1; maximum score is 5 = most severe
Change in health related quality of life [QoL] from baseline for participants: CDQLI
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)
Improvement of itch; Visual Analogue Score (VAS), from baseline
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
Improvement of sleep; Visual Analogue Score (VAS), from baseline
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
Change in adverse impact on participants' families from baseline
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)
Change of patient reported eczema activity from baseline
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)
Change in medication requirements (topical immunomodulators) from baseline
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
Change in sleep quality from baseline: actigraphy
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.
Full Information
NCT ID
NCT03795506
First Posted
December 18, 2018
Last Updated
September 22, 2022
Sponsor
Imperial College London
Collaborators
JP Moulton Charitable Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03795506
Brief Title
TLA in Children With Moderate to Severe Atopic Eczema (TLA4AE)
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
JP Moulton Charitable Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis Eczema
Keywords
Atopic Dermatitis Eczema
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active TLA Device
Arm Type
Experimental
Arm Description
12 week overnight treatment with the active Temperature Controlled Laminar Airflow device.
Arm Title
Placebo TLA Device
Arm Type
Placebo Comparator
Arm Description
12 week overnight treatment with the placebo Temperature Controlled Laminar Airflow device.
Intervention Type
Device
Intervention Name(s)
Nocturnal Temperature controlled Laminar Airflow (TLA) Treatment
Intervention Description
12 weeks of overnight treatment with active TLA device
Intervention Type
Device
Intervention Name(s)
Placebo TLA Device
Intervention Description
12 weeks of overnight use of placebo TLA device
Primary Outcome Measure Information:
Title
Change of eczema severity (Eczema Area Severity Index = EASI Score, total) at week 12 compared to baseline
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)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
(Eczema Area Severity Index = EASI): EASI 50, EASI 75
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)
Time Frame
12 weeks
Title
Change in SCORing Atopic Dermatitis = SCORAD Index
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)
Time Frame
12 weeks
Title
Proportion of subjects achieving Investigator Global Assessment (IGA) of 0 or 1
Description
Proportion of subjects achieving Investigator Global Assessment (IGA) of 0 or 1; maximum score is 5 = most severe
Time Frame
12 weeks
Title
Change in health related quality of life [QoL] from baseline for participants: CDQLI
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)
Time Frame
20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
Title
Improvement of itch; Visual Analogue Score (VAS), from baseline
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
Time Frame
20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
Title
Improvement of sleep; Visual Analogue Score (VAS), from baseline
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
Time Frame
20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
Title
Change in adverse impact on participants' families from baseline
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)
Time Frame
20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
Title
Change of patient reported eczema activity from baseline
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)
Time Frame
20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
Title
Change in medication requirements (topical immunomodulators) from baseline
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
Time Frame
20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
Title
Change in sleep quality from baseline: actigraphy
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.
Time Frame
4-6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 4 to 16 years at time of consent
Persistent moderate to severe eczema despite treatment with topical corticosteroids (TCS) Class II or more and/or topical calcineurin inhibitors (TCI, licenced use only) for at least 3 months.
Eczema Area and Severity Index (EASI) Score ≥12 at screening and randomisation visit and >10% body surface involved
Sensitisation to house dust mite species, confirmed by specific Immunoglobulin E (ImmunoCAP ≥2) and/or Skin Prick Test (SPT ≥5mm)
Child able to sleep in their own bed and able to use the device for at least 5 out of 7 nights per week
Written, informed consent of parent/legal guardian and patient assent
Exclusion Criteria:
very severe atopic dermatitis
use of systemic immunosuppression (such as cyclosporine, methotrexate, azathioprine, oral steroids) or UV therapy or extracorporal photopheresis within four weeks prior to the screening visit
received therapeutic monoclonal antibodies (such as Omalizumab or Dupilumab) within six months prior to the screening visit
Ongoing or planned desensitisation / immunotherapy during the study
Infections requiring systemic antimicrobial treatment within four weeks prior to the screening visit
Introduction of special dietary restriction (for eczema treatment) within three months prior to screening visit
Severe asthma ≥ Step 4 and/or ≥1 course of systemic oral steroids for asthma in the three months prior to screening visit
Significant underlying chronic medical condition (chronic other skin disease, inflammatory bowel disease, immunodeficiencies, other uncontrolled systemic disease, cancer)
Planned time away from home (=unable to use TLA) exceeding 2 days/week; unable to use the device at least 5/7 days in the 2-3 weeks prior to end of intervention period.
Prior research participation is not an exclusion criterion, except if it involved eczema disease modifying agents.
Participating in current research
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Gore, MD PhD
Phone
+44 203 312 6650
Email
cgore@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Gore, MD PhD
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
IMPERIAL COLLEGE HEALTHCARE NHS Trust
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudia Gore, PhD
Email
cgore@nhs.net
First Name & Middle Initial & Last Name & Degree
Claudia Gore, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29383776
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.
Results Reference
background
PubMed Identifier
24750266
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.
Results Reference
background
PubMed Identifier
27898693
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.
Results Reference
background
PubMed Identifier
22131290
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.
Results Reference
background
Learn more about this trial
TLA in Children With Moderate to Severe Atopic Eczema (TLA4AE)
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