Medical devices · Private label
AllersprayTreatment and prevention
of allergic rhinitis
Pollen, dust mites, mould and animal allergens: a response to a wide range of everyday allergens.
Allerspray is a nasal spray for the treatment and prevention of allergic rhinitis in adults and children aged 6 and over. It helps relieve nasal congestion, runny nose, sneezing and itching associated with seasonal or year-round allergies. Its physical action at the nasal surface addresses varied exposures, indoors and outdoors.
This medical device combines local physical action with simple spray application. Supplied in a 15 mlbottle, with a carton and instructions for use, it is available to partners looking to introduce a product under their own brand. Other versions are available to meet their range requirements.
Your nasal spray for allergies,
under your brand
Clinical trial
Randomised, double-blind study against physiological saline.
Population
Adults and children aged 6 and over.
Indication
Treatment and prevention of allergic rhinitis, all allergens.
Benefits
for patients
- Immediate action (osmotic mechanical action).
- Helps relieve nasal congestion, runny nose, sneezing and itching.
- Forms a protective barrier against a wide range of allergens: pollen, dust mites, mould and animal allergens.
- Cleans and helps protect the nasal mucosa.
- Helps reduce eye discomfort associated with allergic rhinitis.
- Free from antihistamines and corticosteroids.
- 100% plant-derived ingredients.
Mode of action
Allerspray forms a protective film on the surface of the nasal mucosa. Based on Vitrobio's film-forming glycerol technology, this film combines three complementary functions that act simultaneously:
- Protecting the mucosa: the film forms a barrier that limits direct contact with allergens.
- Cleaning the nasal surface: its osmotic action draws fluids towards the film and helps remove material present on the surface.
- Trapping allergy-related agents: selected polymers capture allergens and local mediators within the film, reducing their availability at the mucosal surface.
This action takes place on the surface, without polymers penetrating the tissues. Allerspray contains no antihistamines or corticosteroids.
Clinical data · AAG formulation
Clinical study
Nasal relief observed from the first week, progressing over the course of treatment. A randomised, double-blind study compared the AAG formulation with physiological saline for three weeks in patients with seasonal or persistent allergic rhinitis. The protocol specified participants aged 8 to 65; 48 patients received treatment and 46 completed the study, including 31 on AAG and 15 on physiological saline.
| Outcome: decrease in score from baseline | Allerspray (AAG) | Physiological saline | Between-group comparison |
|---|---|---|---|
| Nasal symptoms at 1 week | 45.0 % | 11.7 % | p < 0.05 |
| Nasal symptoms at 3 weeks | 77.5 % | 15.1 % | p < 0.05 |
| Eye symptoms at 3 weeks | 69.7 % | 15.8 % | p < 0.05 |
The nasal score combines runny nose, congestion, sneezing and itching. The eye score combines eye itching, watering and redness. A decrease reflects lower symptom intensity.
Percentages follow the published adjustment of comparator-group scores to harmonise baseline levels. P-values refer to between-group score differences at each time point; a value below 0.05 indicates a statistically significant difference.
Good tolerability was observed in this study, with no adverse event considered related to the product.
The detailed clinical dossier is available on request under a non-disclosure agreement.
Manufacturing & quality
Certified French manufacturing
Allerspray is manufactured in France at the Vitrobio laboratory. Its Origine France Garantie certification is issued by Bureau Veritas.
ISO 13485
Quality management system certified by GMED.
Product details
| Field | Value |
|---|---|
| Code | AAG |
| Public name | Allerspray |
| Product type | Medical device |
| Regulatory class | Class IIa |
| Regulatory framework | Regulation (EU) 2017/745 on medical devices |
| Notified body | GMED |
| Population / age | Adults and children aged 6 and over |
| Category | Allergic rhinitis |
| Full official indication | Treatment and prevention of allergic rhinitis, all allergens |
| Composition | Film-forming glycerol, Allercyanidin-G |
| Format / volume | 15 ml nasal spray, with carton and instructions for use |
| Shelf life before opening | 3 years |
| Storage conditions | Below 25 °C |
| Legal manufacturer | Vitrobio |
| Country of manufacture | France, manufactured in-house |
| Quality system | Quality management system certified to ISO 13485 by GMED |
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