Temperature-controlled laminar airflow (TLA) device in the treatment of children with severe atopic eczema: Open-label, proof-of-concept study

Abstract

Background

Children with severe, persistent atopic eczema (AE) have limited treatment options, often requiring systemic immunosuppression.

Objective

To evaluate the effect of the temperature-controlled laminar airflow (TLA) treatment in children/adolescents with severe AE.

Methods

We recruited 15 children aged 2-16 years with longstanding, severe AE and sensitization to ≥1 perennial inhalant allergen. Run-in period of 6-10 weeks (3 visits), was followed by 12-month treatment with overnight TLA (Airsonett^®, Sweden). The primary outcome was eczema severity (SCORAD-Index and Investigator Global Assessment-IGA). Secondary outcomes included child/family dermatology quality of life and family impact questionnaires (CDQLI, FDQLI, DFI), patient oriented eczema measure (POEM), medication requirements, and healthcare contacts. The study is registered as ISRCTN65865773.

Results

There was a significant reduction in AE severity ascertained by SCORAD and IGA during the 12-month intervention period (P<0.001). SCORAD was reduced from a median of 34.9 [interquartile range 28.75-45.15] at baseline to 17.2 [12.95-32.3] at the final visit, and IGA improved significantly from 4 [3-4] to 2 [1-3]. We observed a significant improvement in FDQLI (16.0 [12.25-19.0] to 12 [8-18], P=0.023) and DFI (P=0.011), but not CDQLI or POEM. Compared to 6-month period prior to enrollment, there was a significant reduction at six months after the start of the intervention in potent topical corticosteroids (P=0.033). The exploratory cluster analysis revealed two strongly divergent patterns of response, with 9 patients classified as responders, and 6 as non-responders.

Conclusion and Clinical Relevance

Addition of TLA device to standard pharmacological treatment may be an effective add-on to the management of difficult-to-control AE.

This article is protected by copyright. All rights reserved.

http://ift.tt/2DOR89c