HAY FEVER: ALLERGIC RHINITIS
Physiopathology:
Nearly 15-20% world population suffers from Allergic Rhinitis. Mast cells are naturally present on the surface of the nasal mucosa. When an allergen comes in contact with the nasal mucosa, T&B cell activation produces IgE antibiodies which attach to the mast cells & trigger the release of histamines. This increases vascular permeability, mucus secretion, and consequently the signs of sneezing, runny nose, itchy eyes, … Histamine, in turn, leads to the production of multiple cytokines: anti-inflammatory to heal & pro-inflammatory to maintain the inflammation & the repair process. The key pro-inflammatory cytokines (proteins) involved are: IL-1, IL-6, IL-12, IL-17, IL-18, TNF-α
Ideal Treatment Approach:
MUST BE MULTI-TARGET TO:
- Protect the nasal mucosa by preventing contact between allergen & mucosa to reduce trigger of exaggerated immune response to allergens
- Clean the nasal mucosa by reducing inflammation and providing an environment favorable to mucosa repair and local defenses. Stop allergen entry.
- Stop rhinorrhea (runny nose), sneezing and itching. Use a non-toxic, non-irritant, long-lasting, natural, topical bandage without any systemic effects.
Current situation:
Many OTC & a few Rx drugs such as corticosteroids, antihistamines, decongestants, leukotriene receptor antagonists, mast cell stabilizers, anticholinergic are used but they may have multiple side effects & they are chemicals.
Class I Medical Device: 15 ml spray for the treatment of Allergic Rhinitis
ALLERSPRAY is the 1st preventive, safe & long-lasting treatment for allergic rhinitis.
VITROBIO’s Completely NEW Therapeutic Approach:
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 polymers to form an isotonic, long-lasting, protective film over the nasal mucosa. Allerspray medical device 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. Stopping allergen entry into the body by filling-up nasal mucosa gaps constitute an ideal remedy against hay fever allergy (For detailed mode of action: please contact Vitrobio).
Product Presentation: 15 ml spray for topical application on the nasal mucosa.
Posology:
PREVENTIVE & SYMPTOMATIC TREATMENTS : 3-4 sprays in each nostril, preferably half an hour before being exposed to the allergenic substance or before entering the allergenic environment every 5-6 h. Less frequent applications for symptomatic relief.
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 (soon Class II) in Europe.
Contraindications: None (can be used over 8 years of age).
Side Effects: None
Clinical Efficacy:
A double blind, randomized, placebo-controlled study was conducted in continuous allergen exposed AR suffering patients at Nexus Clinical Research. 31 patients were treated with Allerspray v/s 15 with saline solution, 3-4 applications per day for 3 weeks. Results show that Day 1 post dose (scoring made 30min after 1st product administration) effects are very marked. Day 2 mean rTNSS is comparable to Day 1 iTNSS, but all allergic rhinitis relief progresses continuously through week 3, indicating that unlike currently available anti-allergic drugs, Allerspray reduces progressively and effectively the allergen-induced symptomatic manifestations of rhinitis. Even after 3 weeks of treatment, there were no side effects or rebound effects, which is a big plus compared to existing drugs.
Full trial published in Journal of Allergy & Therapy, 2017: A New Class of Polymeric Anti-Allergen Nasal Barrier Film Solution for the Treatment of Allergic Rhinitis
