Clinical proof

“Airsonett is the first simple environmental control intervention with proven quality of life benefits for patients with asthma. Its great attraction to patients is the non-pharmacological approach and the consequent absence of adverse effects. Although drug treatment for asthma is safe and effective, patients do not like taking regular medications to suppress chronic inflammation and would prefer a treatment that prevents that inflammation from occurring in the first place.

Airsonett reduces airway inflammation and thereby relieves symptoms, without the need for drugs or burdensome changes to the home environment. I offer it as a treatment option to my patients with atopic asthma who have suboptimal disease control despite using regular inhaled corticosteroids.”

      Dr. Robert Boyle, Consultant Paediatrician St. Mary’s Hospital, London

Airsonett has undergone rigorous clinical trials over a number of years. The largest trial, The 4A Study, included 282 patients in 19 European asthma clinics. It was a randomised, double-blind, placebo-controlled, parallel-group trial. The objective of the 4A Study was to  determine whether environmental control using nocturnal temperature controlled laminar airflow (TLA) treatment could improve the quality of life of patients with persistent atopic asthma.

The conlusion reached was that the inhalant exposure reduction with TLA improves quality of life, airway inflammation and systemic allergy in patients with persistent atopic asthma. TLA may be a treatment option for patients with inadequately controlled persistent atopic asthma.

The results of the 4A Study was published in Thorax, you will find the full article further down on this page. 

In a more recent study with 32 patients who on average had 3.6 exacerbations per year, the number of severe asthma attacks decreased to, on average, 1.3 after one year of Airsonett treatment (TLA). The study also included the effect on asthma symptoms, pharmaceutical consumption, lung function and healthcare utilization. Airsonett treatment showed a significant positive effect on all these parameters.

A large study, called LASER, which is financed by the British state-owned research institute NIHR was initiated in 2014. A BBC interview with a patient and the principal investigator is found here.

Clinical data

Here you find a selection of clinical data and publications regarding Airsonett (which was previously marketed under the product name Protexo).

Publications

  • Warner JO.  Use of temperature-controlled laminar airflow in the management of atopic asthma: clinical evidence and experience. Ther Adv Respir Dis (2017). Pre-published online as DOI: 10.1177/1753465817690505
  • Brazier P, Schauer U, Hamelmann E, Holmes S, Pritchard C and Warner JO. Economic analysis of temperature-controlled laminar airflow (TLA) for the treatment of patients with severe persistent allergic asthma. BMJ Open Resp Res 2016;3:e000117 doi:10.1136/bmjresp-2015-000117 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4809149/#s3title
  • Schauer U, Bergmann K-C, Gerstlauer M, Lehmann S, Gappa M, Brenneken A, Schulz C, Ahrens P, Schreiber J, Wittmann M, Hamelman E. Improved asthma control in patients with severe, persistent allergic asthma after 12 months of nightly temperature-controlled laminar airflow: an observational study with retrospective comparisons. European Clinical Respiratory J. 2015 Vol 2 http://www.ecrj.net/index.php/ecrj/article/view/28531
  • 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. 2014 Apr 19. doi: 10.1111/ina.12122.
    http://www.ncbi.nlm.nih.gov/pubmed/24750266
  • Boyle RJ, Pedroletti C, Wickman M, Bjermer L, Valovirta E, Dahl R, von Berg A, Zetterström O, Warner JO.  Nocturnal temperature controlled laminar airflow for treating atopic asthma: a randomised controlled trial. Thorax (2011). doi:10.1136/thoraxjnl-2011-200665 http://thorax.bmj.com/content/early/2011/11/07/thoraxjnl-2011-200665.long
    Abstract: http://www.ncbi.nlm.nih.gov/pubmed/22131290
  • Brodtkorb T. Cost-effectiveness of clean air administered to the breathing zone in allergic asthma. (2009) submitted. Brodtkorb TH, Zetterström O, Tinghög G. Cost-effectiveness of clean air administered to the breathing zone in allergic asthma. Clin Respir J. 2010 Apr;4(2):104-10
  • Pedroletti C, Millinger E, Dahlén B, Söderman P, Zetterström O. Clinical effects of purified air administered to the breathing zone in allergic asthma: A double-blind randomized cross-over trial. Pedroletti C, Millinger E, Dahlén B, Söderman P, Zetterström O. Respir Med. 2009 May 12
  • Gore RB, Boyle RJ, Hanna H, Custovic A, Gore C, Svensson P, Warner JO. Personal allergen exposures are increased by changes in sleep position and improved by temperature-controlled laminar airflow. Thorax 2010;65:A87-A88 doi:10.1136/thx.2010.150961.27. http://thorax.bmj.com/content/65/Suppl_4/A87.2.abstract?sid=c9c967cd-d694-4504-95a5-39cd73a3f08f
  •  Söderman P, Hyllensved Y, Pedroletti C, The effect of clean air treatment with Airsonett Airshower  – a  clinical case report based on 22 atopic children (article in Swedish), Riksstämman 2008
  • Bräuner EV, Forchhammer L, Møller P, Barregard L, Gunnarsen L, Afshari A, Wåhlin P, Glasius M, Dragsted LO, Basu S, Raaschou-Nielsen O, Loft S. Indoor particles affect vascular function in the aged: an air filtration-based intervention study. Am J Respir Crit Care Med. 2008 Feb 15;177(4):419-25. Epub 2007 Oct 11
  • Svensson P. Influence of clean air directly in the breathing zone on allergy and asthma patients during night-time. The Journal of Allergy and Clinical Immunology, February 2005 Vol. 115, Issue 2, Page 239
  • P. Svensson. Low energy cost and less sick leave with displacement ventilation versus mixing ventilation. Roomvent 9th International conference (2004) 64-65
  • Andersson I-M, Rosén G, Kristensson J. Evaluation of a ceiling-mounted low-impulse air inlet for control of air pollution. National Institute of Health, Sweden, 1995.
  • Kristensson J. Proceedings of the 4th International Symposium on ventilation for contamination control, (1994) 477-484
  • Kristensson J, O A Lind. ASHRAE CH-93-9-4(1993)

Posters in pdf format

Other references for texts published on this website

Custovic A et al. Allergen avoidance in the treatment of asthma and atopic disorders. Thorax 1998;53:6372

Piacentini GL et al. Allergen avoidance is associated with a fall in exhaled nitric oxide in asthmatic children. J Allergy Clin Immun. 1999;104(6):1323-4.

Perons DG et al. Mite avoidance can reduce air trapping and airway inflammation in allergic asthmatic children. Clin Exp Aller. 2002 Jun;32(6):850-5

Grootendorst DC et al. Benefits of high altitude allergen avoidance in atopic adolescents with moderate to severe asthma, over and above treatment with high dose inhaled steroids. Clin Exp Allergy 2001;31:400-408.

Kilburn SA, Lasserson TJ, McKean MC. Pet allergen control measures for allergic asthma in children and adults. Cochrane Database of Systematic Reviews 2001, Issue 1. Art. No.: CD002989. DOI: 10.1002/14651858.CD002989.

Gøtzsche PC, Johansen HK. House dust mite control measures for asthma. Cochrane Database of Systematic Reviews 2008, Issue 2. Art. No.: CD001187. DOI: 10.1002/14651858.CD001187.pub3.

Gerhard Schultze-Werninghaus. Should Asthma Management Include Sojourns at High Altitude? Allergy and Asthma in Modern Society: A Scientific Approach. Chem Immunol Allergy. Basel, Karger, 2006, vol 91, pp 16–29

Custovic A et al. Allergen avoidance in the treatment of asthma and atopic disorders. Thorax 1998;53:6372

Piacentini GL et al. Allergen avoidance is associated with a fall in exhaled nitric oxide in asthmatic children. J Allergy Clin Immun. 1999;104(6):1323-4.

Perons DG et al. Mite avoidance can reduce air trapping and airway inflammation in allergic asthmatic children. Clin Exp Aller. 2002 Jun;32(6):850-5

Grootendorst DC et al. Benefits of high altitude allergen avoidance in atopic adolescents with moderate to severe asthma, over and above treatment with high dose inhaled steroids. Clin Exp Allergy 2001;31:400-408.

Kilburn SA, Lasserson TJ, McKean MC. Pet allergen control measures for allergic asthma in children and adults. Cochrane Database of Systematic Reviews 2001, Issue 1. Art. No.: CD002989. DOI: 10.1002/14651858.CD002989.

Gøtzsche PC, Johansen HK. House dust mite control measures for asthma. Cochrane Database of Systematic Reviews 2008, Issue 2. Art. No.: CD001187. DOI: 10.1002/14651858.CD001187.pub3.

Gerhard Schultze-Werninghaus. Should Asthma Management Include Sojourns at High Altitude? Allergy and Asthma in Modern Society: A Scientific Approach. Chem Immunol Allergy. Basel, Karger, 2006, vol 91, pp 16–29.