%0 Clinical Trial
%T Temperature-controlled laminar airflow (TLA) device in the treatment of children with severe atopic eczema: Open-label, proof-of-concept study.
%A Gore C
%A Gore RB
%A Fontanella S
%A Haider S
%A Custovic A
%J Clin Exp Allergy
%V 48
%N 5
%D 05 2018
%M 29383776
%F 5.401
%R 10.1111/cea.13105
%X Children with severe, persistent atopic eczema (AE) have limited treatment options, often requiring systemic immunosuppression.<BR>To evaluate the effect of the temperature-controlled laminar airflow (TLA) treatment in children/adolescents with severe AE.<BR>We recruited 15 children aged 2-16 years with long-standing, 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.<BR>There was a significant reduction in AE severity ascertained by SCORAD and IGA during the 12-month intervention period (P < .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 = .023) and DFI (P = .011), but not CDQLI or POEM. Compared to 6-month period prior to enrolment, there was a significant reduction at six months after the start of the intervention in potent topical corticosteroids (P = .033). The exploratory cluster analysis revealed two strongly divergent patterns of response, with 9 patients classified as responders, and 6 as non-responders.<BR>Addition of TLA device to standard pharmacological treatment may be an effective add-on to the management of difficult-to-control AE.