2021-08-12 09:48News

New observational study shows significant effect of Airsonett TLA treatment on adult atopic dermatitis patients


Airsonett announced today a new observational study showing a significant effect of Airsonett TLA (Temperature-controlled Laminar Airflow) for treating adult atopic dermatitis (AD) patients. The proof-of-concept study is published in the Journal of the European Academy of Dermatology and Venereology.

Atopic dermatitis patients are commonly sensitized to house dust mites. The current consensus-based European guideline underlines the impact of allergens inducing AD flares and the Im-portance of allergen reduction in AD patients. Atopic dermatitis has a complex relationship with atopic comorbidities, including asthma. (1) Nightly treatment with Airsonett TLA reduces allergens and particles in the breathing zone by 99.5%. (2)

The three-month observational study, with an extension phase of an additional 9 months, investigated the effect of an add-on treatment with TLA in 10 HDM-IgE-sensitized patients with moderate-to-severe AD and a history of clinically relevant house dust mite allergy. The study showed significant improvement in a majority of the patients, measured as SCORAD, EASI, PGA, DLQI. In vitro analysis was also performed after 3 and 12 months, underpinning the clinical results.

Excerpt from the conclusion in the publication:
“Together, the findings of this proof-of-concept study indicate improvement of disease severity in HDM-sensitized adult AD patients during the add-on treatment with a TLA device. In conclusion, this study is the first to suggest beneficial effects of TLA in HDM-sensitized adult AD patients regarding objective, subjective and in vitro parameters.”

Anders Due-Boje, CEO of Airsonett, said: “We are very excited for the results of this study, which confirms our experiences of patients that receive Airsonett TLA treatment for their allergic asthma and also have atopic dermatitis. Hopefully, TLA can soon be established as an effective standard treatment for AD patients as well.”

For more information:

Anders Due-Boje, CEO, Airsonett AB
Phone: +46 70 526 03 00
E-mail: anders.due-boje@airsonett.eu


About Airsonett
Airsonett® is a Swedish medical device company that leads the way in the development of non-pharmacologic treatment of allergic severe asthma and eczema. Airsonett® Air4 is a non-invasive device for treatment in the home, based on the patented Temperature-controlled Laminar Airflow technology (TLA). Treatment with the Airsonett® Air4 significantly reduces allergens and other airborne irritants from the patient’s breathing zone during rest and sleep. Airsonett® Air4 is a CE marked class 1 medical device intended to be used for the alleviation of symptoms of allergy-induced diseases such as allergic asthma and eczema. It adheres to relevant EU directives regarding design, function, safety and health requirements and has undergone rigorous clinical research as well as health-economic studies. Airsonett® Air4 holds a 510(k) cleared class II approval from FDA. The company’s main shareholders are SEB Venture Capital, Industrifonden and Magnus Lundberg. For more information visit www.airsonett.eu


About severe, uncontrolled asthma
Patients with severe, uncontrolled asthma treated according to Global Initiative for Asthma (GINA) step 4/5 account for approximately 3% of all patients with persistent asthma, according to recent population-based studies using administrative and prescribed databases, but account for a much larger share of asthma-related healthcare resource use and costs. Treatment alternatives for such patients include high-dose inhaled corticosteroids (ICS) and long-acting β2-antagonists (LABAs) and/or systematic corticosteroids. During the last decade, several new drugs for the treatment of severe asthma have been developed, and some of these drugs, such as anti-immunoglobulin E and anti-interleukin 5 have been included in Step 5 in the latest GINA recommendations. The costs for treatment with these biologics are however very high. Temperature-controlled laminar airflow (TLA) is an effective treatment for patients with severe, uncontrolled asthma. The use of TLA has shown cost-effectiveness according to National Institute for Health and Care Excellence (NICE) standards and the Swedish Dental and Pharmaceutical Benefits Agency, TLV, a central government agency whose remit is to determine whether a pharmaceutical product, medical device or dental care procedure shall be subsidized by the state.


1: Comorbidities and the impact of atopic dermatitis, Jonathan I.SilverbergMD, PhD, MPH

2: Spilak M, Sigsgaard T, Takai H, et al. A comparison between temperature-controlled laminar airflow device and a room air-cleaner in reducing exposure to particles while asleep. PLoS ONE 2016;11(11): e0166882. doi:10.1371/journal.pone.0166882

About Airsonett

Airsonett® är ett svenskt medicintekniskt företag som är ledande inom icke-farmakologisk behandling av patienter med allergisk svår, okontrollerad astma och eksem. Airsonett® Air4 är en icke-invasiv medicinsk utrustning för hembehandling baserad på den patenterade tekniken Temperatur-reglerat laminärt luftflöde (TLA). Behandling med Airsonett® Air4 medför drastisk minskning av allergener och andra luftburna partiklar i patientens andningszon under vila och sömn. Airsonett® Air4 rekommenderas av Socialstyrelsen och Barnläkarföreningen samt ingår sedan 2015 i Läkemedelsverkets riktlinjer för astmabehandling. Airsonett® Air4 är en CE-märkt medicinteknisk utrustning, Klass 1, avsedd att användas för lindring av symtom vid allergiska sjukdomar såsom allergisk astma och eksem. Den följer relevanta EU-direktiv gällande utformning, funktion, säkerhet, hälsokrav och har genomgått rigorös klinisk forskning så väl som hälsoekonomiska analyser. Airsonett® Air4 innehar ett 510(k) godkännande, klass II, från FDA. Bolagets huvudägare är SEB Venture Capital, Industrifonden och Magnus Lundberg. För ytterligare information, besök www.airsonett.se


Head of Marketing
Andreas Arnkvist
Anders Due-Boje