Clinical trial NCT03795506: 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
Overall status: RECRUITING
Phase: NA
Conditions: Atopic Dermatitis Eczema
Keywords: Atopic Dermatitis Eczema
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: JP Moulton Charitable Foundation
First posted: 2019-01-07
Enrollment: 96
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of eczema severity (Eczema Area Severity Index = EASI Score, total) at week 12 compared to baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: (Eczema Area Severity Index = EASI): EASI 50, EASI 75
timeFrame: 12 weeks
measure: Change in SCORing Atopic Dermatitis = SCORAD Index
timeFrame: 12 weeks
measure: Proportion of subjects achieving Investigator Global Assessment (IGA) of 0 or 1
timeFrame: 12 weeks
measure: Change in health related quality of life [QoL] from baseline for participants: CDQLI
timeFrame: 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
measure: Improvement of itch; Visual Analogue Score (VAS), from baseline
timeFrame: 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
measure: Improvement of sleep; Visual Analogue Score (VAS), from baseline
timeFrame: 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
measure: Change in adverse impact on participants' families from baseline
timeFrame: 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
measure: Change of patient reported eczema activity from baseline
timeFrame: 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
measure: Change in medication requirements (topical immunomodulators) from baseline
timeFrame: 20-22 weeks (baseline 4-6 weeks, intervention 12 weeks, 4 weeks after intervention)
measure: Change in sleep quality from baseline: actigraphy
timeFrame: 4-6 weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: IMPERIAL COLLEGE HEALTHCARE NHS Trust
Study officials:
affiliation: Imperial College London
name: Claudia Gore, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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: 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.