New study evaluates Airsonett TLA technology in the treatment of children with severe atopic eczema
Airsonett announced today that the company’s novel and proprietary technology TLA (Temperature-controlled Laminar Airflow) would be evaluated in the treatment of children with severe atopic eczema. Imperial College London UK will perform and sponsor the single centre, randomized placebo-controlled study. The study is a result of the positive results already seen in the proof of concept study published in May 2018 (ref.1,2)
The primary objective is to assess the clinical efficacy of overnight treatment with the TLA device in children and adolescents with chronic, moderate to severe atopic eczema. The primary endpoint is mean change of eczema severity EASI at week 12 compared to baseline. The study was initially scheduled to start in early 2020 but was delayed due to Covid-19. The first patients were enrolled in October 2020.
"We are excited to see the outcome of this study, hopefully confirming the good results in the previous proof of concept study. We often see promising improvements in eczema symptoms among many patients that receive TLA treatment for their allergic asthma “, says Anders Due-Boje, CEO of Airsonett.
“We are very pleased, that we are now finally able to go ahead and investigate if the TLA provides benefit to children with moderate to severe eczema” says Dr Claudia Gore, trial Chief Investigator at Imperial College London.
For more information:
Anders Due-Boje, CEO, Airsonett AB
Phone: +46 70 526 03 00
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.
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
1: Effect of a novel temperature-controlled laminar airflow device on personal breathing zone aeroallergen exposure.
Gore RB, Boyle RJ, Gore C, Custovic A, Hanna H, Svensson P, Warner JO.
Indoor Air. 2015 Feb;25(1):36-44. doi: 10.1111/ina.12122. Epub 2014 Jun 10.
2: Temperature-controlled laminar airflow (TLA) device in the treatment of children with severe atopic eczema: Open-label, proof-of-concept study.
Gore C, Gore RB, Fontanella S, Haider S, Custovic A.
Clin Exp Allergy. 2018 May;48(5):594-603. doi: 10.1111/cea.13105. Epub 2018 Mar 13.