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INTRODUCTION
Intended use
Alleviation of symptoms of allergy induced diseases such as allergic asthma. Airsonett provides a reduction of airborne particle exposure (eg.
allergen) by means of Temperature controlled Laminar Airflow (TLA). The device is intended for home use.
Treatment of allergic asthma and other allergy induced diseases
Allergy induced diseases such as asthma is a common health problem. Having allergic asthma means that allergen exposure can worsen your
asthma symptoms. The allergens that you are sensitized to can trigger inflammation of the airways in your lungs. The lining of your
breathing tubes becomes easily irritated, swollen and clogged with mucus and fluid making it harder to breathe. In addition to taking regular
asthma medications, avoiding exposure to the allergens that you are sensitized to can help to reduce the airway inflammation and asthma
symptoms.
Other allergy induced diseases, such as allergic rhinitis and allergic eczema or atopic dermatitis, can also be triggered by inhalant allergens.
Minimizing inhalant allergens may therefore alleviate symptoms of these diseases as well.
Airsonett is developed to minimize allergen exposure in the breathing zone when lying in bed
During night the concentration of indoor airborne allergens in the breathing zone is primarily generated from bed reservoirs (e.g. house dust
mite and pet allergens) and is higher than the concentration of allergens in the ambient bedroom air.
1
The reason for the difference in
concentration of allergens in the breathing zone and the room in general is the body convection; the air warmed by the body in the bed
creates an airflow that rises due to the lower density of the warm air.
2
The warm air transports the allergens present in the bedding towards
the opening in the duvet where it rises and passes by the breathing zone. Airsonett effectively displaces the allergen rich body convection and
dramatically reduces the level of inhalant allergens during sleep. This way your airways may rest from allergen exposure overnight.
Technology
Airsonett is based on the Temperature controlled Laminar Airflow (TLA) technology. The Airsonett device is placed next to the bed, with air
supply nozzle positioned over the head. The air from the room enters the Airsonett and passes a filter that captures allergens and other
particles. The filtered air is then cooled to slightly below the ambient room temperature before it is gently released from the air supply
nozzle. Since the filtered air is slightly cooler, and therefore heavier than the surrounding air, the filtered air will descend slowly from the air
supply nozzle by means of gravity in a laminar manner (non-turbulent). This descending colder air will push away the particles and allergens
that have risen with the warm air from the bed and gathered in the breathing zone. Airsonett has been shown to reduce the amount of
particles and allergens in the breathing zone by 99.5%, and to keep it clean all through the night.
Clinical data
The effectiveness and safety of the Airsonett TLA technology has been evaluated in three clinical studies, including more than 300 patients
with perennial (all-year round) allergic asthma who had symptoms despite taking regular asthma medications.
3-5
The largest study included
312 patients, aged 7-70 years, that used either the Airsonett or a dummy device (placebo) in their own bedroom for a year.
3
The results
showed that patients who used the Airsonett device in addition to their regular asthma medication had less inflammation in their airways and
felt that they had less asthma symptoms and a better health-related quality of life. The Airsonett treatment was very well tolerated with a
similar side effect profile as placebo.
Precaution
Airsonett is to be used in addition to regular pharmaceutical treatments. Airsonett is used for regular treatment, not for acute relief or
emergency treatment. This means you should use your Airsonett every night in combination with prescribed medication. Always consult
your doctor before changing or reducing your medication. At any uncertainty, contact your doctor.
Pregnancy, breast-feeding and small children
Experience from using Airsonett during pregnancy, breast-feeding and in small children is limited. However, Airsonett does not supply any
substances that can affect the pregnancy, breast-feeding or small children.
Side effects
As a non-invasive, non-pharmacological treatment Airsonett has an inherent beneficial safety profile. The adverse events reported in a large
clinical study were very similar between the Airsonett group and the placebo group.
3
Usage
Airsonett is placed next to the bed and is easy to use. Effectiveness is dependent on following these Instructions for Use. Use your Airsonett
every night in combination with prescribed medication. Sporadic use of Airsonett reduces the effectiveness.
