ALLERSPRAY Kids
Physiopathology:
AR is common, affecting 15-30% of children & the prevalence in the industrialized world is increasing very fast. AR in children is characterized by frequent sneezing, rhinorrhea, nasal obstruction, and is often accompanied by itching of eyes, nose & palate. Postnasal drip, cough, irritability & fatigue are other common symptoms.
The physiopathology of AR in children is identical to adults and is related to an exaggerated immune reaction to some native antigens. When allergens come in contact with the nasal mucosa, the activation of mast cells, T & B -immune cells produces histamine & IgE antibodies, which leads to the release of cytokines (proteins), inflammation, & symptoms of allergic rhinitis.
Ideal Treatment should:
- Protect the nasal mucosa by preventing contact between allergen & mucosa to reduce the exaggerated immune response to allergens
- Soothe the nasal mucosa by reducing inflammation and providing an environment favorable to mucosa repair and local defenses.
- Stop rhinorrhea (runny nose), sneezing and itching
- Use a non-toxic, non-irritant, long-lasting, natural, topical bandage without any systemic effects.
Class I Medical Device: 15 ml spray for the treatment of Allergic Rhinitis in children
ALLERSPRAY-KIDS is the 1st preventive, safe & long-lasting allergic rhinitis treatment for children.
Current situation:
Many OTC & a few Rx drugs such as corticosteroids, antihistamines, decongestants, leukotriene receptor antagonists, mast cell stabilizers, anticholinergic have multiple side effects. This is the reason why it’s difficult to treat AR in children.
Estimated market for a safe, topically and nearly instantly acting AR treatment for children: a few billion US$.
VITROBIO’s Completely NEW Therapeutic Approach:
(European PAEXA Research Award & French Academy of Science Award).
For the last 20 years, Vitrobio has been conducting R&D to conceive a topical treatment with preventive & immediate relief properties, capable of protecting the nasal mucosa against allergens and irritants, so as to reduce the allergic reaction, improve natural defenses, and provide symptomatic relief. Vitrobio’s objective was to find a natural, safe, non-irritant and easily applicable liquid bandage that could fulfill all these requirements simultaneously. Vitrobio conceived a filmogen solution containing Allercyanidin-E polymers to form an isotonic, long-lasting, protective film over the nasal mucosa. Allerspray-Kids medical device is specially formulated for the treatment of allergic rhinitis in children aged 3-16 years old. The product acts as a protective absorbent barrier film against allergens, helping to reduce the allergic reaction, irritation, and nasal discharge, thus providing quick relief and improving local natural defenses. (For detailed mode of action: please contact Vitrobio)
Product Presentation: 15 ml spray for topical application on the nasal mucosa.
Posology:
PREVENTIVE TREATMENT: 3-4 sprays in each nostril, preferably half an hour before being exposed to the allergenic substance or before entering the allergenic environment. Repeat every 5-6 h if you remain in contact with the allergen.
SYMPTOMATIC TREATMENT: 2-3 sprays in each nostril, 2-3 times a day or more if necessary, as per the intensity of allergic reaction.
Contraindications: can be used over 3 years of age.
Side Effects: None
Regulatory Status: Due to the mechanical & topical filmogen activity without any pharmacological, biological, metabolic or immunological interaction with the cellular structures, this product is classified as Class I Medical Device in Europe.
Clinical Efficacy:
A double blind, randomized, placebo-controlled study in child AR patients, with 20 patients treated with Allerspray-Kids vs 10 patients treated with saline solution. 3-4 applications per day for 3 weeks showed: Instant & marked reduction in AR symptoms without any side effect. Results showed 36%, 75% & 96% higher reduction of nasal symptoms, and 35%, 75% & 99% of total ocular symptoms for Allerspray-Kids compared to saline, after 1, 2, 3 weeks of treatment respectively, with a corresponding more strongly marked improvement in quality of life score. No side effects were recorded in either group.
