Clinical Data

Airsonett TLA has extensive clinical documentation and is reviewed and recommended by several medical agencies. Please contact us to download further literature or to book a meeting.

Asthma

2023
- Swedish Medical Products Agency (MPO)
  
  reviews the guidelines and still recommends TLA as an add-on treatment for Asthma
2022
- Lawton Retrospective data
  - 12 children (age 6-19)
  - ACT significant improvement
  - TLA treatment may have potential as an add-on, non-pharmacological therapy in selected children and young patients with poorly controlled asthma
- Chauhan
  - 226 patients
  - Post hoc Kapoor
  - Exacerbations p = 0.083 (33%)
  - QoL p = 0.034
2021
- Chauhan
  - 179 patients (age 7-75)
  - Meta-analysis Boyle/ Kapoor
  - 52 weeks
  - Exacerbations p = 0.015
  - QoL p = 0.04
- Miller
  - Health economy Chauhan
  - TLA Cost-effective
  - Well below NICE ICER per QALY threshold (£20K)
  - No biologics has achieved ICER per QALY below $150,000
2020
- Boven
  - A meta-analysis of baseline characteristics in trials on mite allergen avoidance in
    asthmatics.
  - Statistically significant mean differences in the AQLQ scores and FeNO levels in patients with mild to moderate asthma at baseline.
- Warner
  - Allergy prevention article
  - TLA treatment showing improvement in QoL and airway inflammation as in FeNO in severe asthma
2019
- Bjermer
  - 312 patients (7-70)
  - Pivotal within Boyle study
  - 52 weeks
  - 87 patients Time-to-onset QoL 3 months
    p = 0.009
  - 7 patients Time-to-onset Sleep 1 month
    p = 0.037
- Kapoor
  - 240 patients (age 16-75)
  - RCT
  - 52 weeks
  - Exacerbations
  - Inconclusive, under powered
2018
- Gupta
  - Refers Boyle et al
  - Significant improvement in QoL
  - Significantly decreased FeNO
  - Importantly, there was a progressively greater significance of difference as the severity of asthma increased.
- Swedish Medical Products Agency (MPO)
  
  Renewed recommendation
- BLFA guidelines (Swedish Paediatricians’ Association) guidelines
  
  Also recommended for Atopic Dermatitis: “Treatment with Airsonett can be particularly valuable in the combination of severe asthma and severe eczema, as the treatment affects both conditions favourably.”
2017
- Warner Publication
  - TLA have demonstrated significant improvements in QoL and reduction in FeNO
  - Significant reduction of severe exacerbation in patient with worse disease
  - TLA treatment below the NICE threshold for the ICER per QALY
- Wang
  - 23 patients
  - RCT, withdrawal of Omalizumab
  - 48 weeks
  - Exacerbations p = 0.001
- BLFA (Swedish Paediatricians’ Association) guidelines
  
  recommends TLA for “patients with verified perennial airway allergy and uncontrolled asthma despite drug treatment step 4”
2016
- Spilak
  - Climate chamber with manikin
  - TLA vs. Air cleaner
  - ≥0.5 µm; particle exposure > 99.5%, p < 0.001
  - 100-fold vs. Air cleaner, p < 0.001
- Gore RB
  - 12 children (age 8-15)
  - Severe atopic eczema
  - Children slept under device OFF two nights and ON two nights.
  - ≥0.5 µm; particle exposure > 99.5% p < 0.001
- Brazier
  - Health economy Boyle/Schauer
  - TLA Cost-effective
  - Well below NICE ICER per QALY threshold (£20K)
2015
- Gore RB
  - 5 subjects
  - Allergen-rich experimental environment incl. cat allergen
  - ≥0.5 µm; particle exposure reduction > 99.5%, p < 0.001
  - Cat allergen exposure reduction p = 0.043
- Schauer
  - 30 patients (age 8-70 )
  - Observation
  - 52 weeks
  - Exacerbations p < 0.0001
  - ACT < 0.0001
- Swedish Medical Products Agency recommendation
  
  Add-on treatment asthma (MPO)
- The Swedish Dental and Pharmaceutical Benefits Agency (TLV)
  
  considers treatment with TLA to be cost-effective given the data available, provided that the patient corresponds to the indication.
2014
- Bakshi
  - 6 subjects
  - 1 week TLA-treatment in inner city environment
  - Nano particle exposure reduction >99.5%,
  - p = < 0.001
2012
- Boyle
  - 312 patients (age 7-70)
  - RCT
  - 52 weeks
  - QoL p = 0.02
  - poorly ctrl. p < 0.001
  - FeNO p = 0.03 high baseline p = 0.001
  - Cat-specific IgE p = 0.005
- HO
  - 14 patients (adults)
  - RCT, cross-over
  - NRQLQ p = 0.013
  - Decrease in IFN-gamma p = 0.028 (nasal secretions)
2011
- Moffat
  - 53 patients (age 8-16)
  - RCT within Boyle study
  - 52 weeks
  - RQLQ sleep p = 0.019
  - Significant reduction in PNIF
2010
- Ragazzo
  - 9 patients (age 7-12)
  - Proof of concept
  - Patient living in the alps randomized to TLA or control, when moving back home.
  - Showed reduction in inflammation markers as FeNO and sputum EOS
2009
- Pedroletti
  - 22 patients (age 12-33)
  - RCT, cross-over
  - 22 weeks
  - QoL p < 0.05
  - FeNO < 0.05
- Brodtkorb
  - Health Economy Pedroletti study
  - TLA Cost-effective
  - Well below NICE ICER per QALY threshold (€30K)

Atopic dermatitis

2023
- Gore (Ongoing)
  - 96 patients (children)
  - RCT, single centre Imperial College London UK
  - 12weeks
  - EASI
  - SCORAD, DLQI, IGE/PGA
2021
- Traidl
  - 10 patients (age >18)
  - Observational, Proof of concept Hannover University
  - 12 weeks and follow up 9 months
  - SCORAD p = 0.037, EASI p = 0.038
  - DLQI p = 0.001
  - IL9 p = 0.0001
  - First study to show invitro data
2018
- Gore
  - 15 patients (age 2-16)
  - Open label, Proof of concept Imperial Collage London UK
  - 52 weeks
  - SCORAD p = 0.015, IGA p = 0.001
  - FDLQI p = 0.032
- Theodosiou publication
  - 1 patient
  - Patient cases
  - Significant improvement in SCORAD, IGA, DLQI
- BLFA (Swedish Paediatricians’ Association) guidelines
  
  “Treatment with Airsonett can be particularly valuable in the combination of severe asthma and severe eczema, as the treatment affects both conditions favourably.”
2014
- Leitao/Gore
  - 6 patients
  - Proof of Concept
  - 52 weeks
  - QoL and SCORAD improved
  - Reduction of aeroallergens exposure by TLA treatment can improve disease severity and quality of life in children with severe atopic eczema.
2012
- Söderman
  - 8 patients (age 5-16)
  - Case report, Multi centre
  - TLA may be an alternative for subjects with severe perennial allergen-induced AD.