TLA in Children With Moderate to Severe Atopic Eczema (TLA4AE)

Atopic Dermatitis Eczema Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03795506
• Other study ID #: 18SM4747
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2019
• Est. completion date: May 31, 2025

Study information

• Verified date: January 2024
• Source: Imperial College London
• Contact: Sabrina Kapur
• Phone: +44 (0) 7776462345
• Email: imperial.tla4ae[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: May 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis Eczema
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Device:
• Nocturnal Temperature controlled Laminar Airflow (TLA) Treatment
12 weeks of overnight treatment with active TLA device
• Placebo TLA Device
12 weeks of overnight use of placebo TLA device

Locations

Country	Name	City	State
United Kingdom	IMPERIAL COLLEGE HEALTHCARE NHS Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
Imperial College London	JP Moulton Charitable Foundation

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	(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
Secondary	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)	12 weeks
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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