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| Name | Class |
|---|---|
| JP Moulton Charitable Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active TLA Device | Experimental | 12 week overnight treatment with the active Temperature Controlled Laminar Airflow device. |
|
| Placebo TLA Device | Placebo Comparator | 12 week overnight treatment with the placebo Temperature Controlled Laminar Airflow device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nocturnal Temperature controlled Laminar Airflow (TLA) Treatment | Device | 12 weeks of overnight treatment with active TLA device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| (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) | 12 weeks |
| Change in SCORing Atopic Dermatitis = SCORAD Index |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabrina Kapur | Contact | +44 (0) 7776462345 | imperial.tla4ae@nhs.net | |
| Salina Persand | Contact | 0203 312 5298 | imperial.tla4ae@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Claudia Gore, MD PhD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMPERIAL COLLEGE HEALTHCARE NHS Trust | Recruiting | London | W2 1NY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29383776 | Background | 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. | |
| 24750266 | Background | 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. |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Placebo TLA Device | Device | 12 weeks of overnight use of placebo TLA device |
|
Change in total SCORAD Index at week 12 compared to baseline; higher score = higher severity; range 0-103 (0=no eczema, 103 highest severity) |
| 12 weeks |
| 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 | 12 weeks |
| 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) | 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention) |
| 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 | 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention) |
| 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 | 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention) |
| 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) | 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention) |
| 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) | 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention) |
| 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 | 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention) |
| 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. | 4-6 weeks |
| 27898693 | Background | 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. |
| 22131290 | Background | 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. |