Klinisk Data - Airsonett

Airsonett TLA har genomgått omfattande kliniska studier. Klinisk data har utvärderats och rekommenderas av ett flertal medicinska organisationer. Kontakta oss gärna om du vill veta mer eller boka ett möte för en utförlig presentation.

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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.