Medical devices · Private label
Allerspray UrbanRhinitis associated
with pollution
Urban pollution, industrial emissions, dust and fumes: nasal protection suited to polluted environments. Allerspray Urban is a nasal spray for the treatment and prevention of allergic rhinitis associated with environmental pollutants, in adults and children aged 8 and over. It relieves symptoms of mild to moderate intermittent allergic rhinitis: nasal congestion, runny nose, sneezing and itching. Its positioning specifically addresses exposure to airborne particles, some of which may contain heavy metals.
This medical device acts locally at the nasal surface to limit contact with irritants and facilitate their removal. It also contributes to eye comfort associated with rhinitis. Supplied as a spray of 15 ml, with carton and instructions for use, Allerspray Urban enables partners to offer a product specifically addressing pollution-related needs under their own brand.
Your product for pollution-related rhinitis,
under your brand
Clinical study
Randomised study over 22 days; 44 participants completed the study.
Population
Adults and children aged 8 and over.
Indication
Treatment and prevention of allergic rhinitis associated with environmental pollutants.
Benefits
for patients
- Immediate action (osmotic mechanical action).
- Forms a protective barrier against airborne environmental irritants.
- Helps remove pollutants and irritants from the nasal surface.
- Relieves nasal congestion, runny nose, sneezing and itching.
- Helps reduce eye discomfort associated with allergic rhinitis.
- Free from antihistamines and corticosteroids.
- 100% plant-derived ingredients.
Mode of action
Allerspray Urban deposits a protective film on the nasal mucosa based on Vitrobio's film-forming glycerol technology. Three complementary functions act simultaneously:
- Protecting the mucosa: the film forms a physical barrier that limits direct contact with airborne environmental irritants.
- Cleaning and decongesting: osmotic action draws fluids towards the film, helps remove surface contaminants and reduces mucosal swelling.
- Retaining contaminants: agents mobilised at the surface are retained within the film, then removed as the film is gradually eliminated.
This action takes place on the surface without polymers penetrating tissues. It supports a clean, protected nasal environment. Osmotic mechanical action begins on application; symptom improvement progresses during treatment.
Clinical study · PCNS formula
Clinical study
Less runny nose from day six, with benefits for eye comfort and quality of life. A randomised parallel-group study compared the PCNS formula, now presented as Allerspray Urban, with 0.9% physiological saline over 22 days. Conducted in a congested urban environment among people with allergen- and/or pollution-induced rhinitis, it planned enrolment between ages 8 and 65. Of 49 randomised participants, 44 completed the study: 29 on PCNS and 15 on physiological saline.
| Benefit and time point | Result from baseline | Between-group score comparison |
|---|---|---|
| Less runny nose on day 6 | 36% decrease in the score with Allerspray Urban | p < 0.001, favouring the product |
| Improved eye comfort on day 22 | 59.7% decrease in the score with Allerspray Urban, versus 26.8% with physiological saline | p < 0.001, favouring the product |
| Less impact of rhinitis on quality of life on day 22 | 46.7% improvement, versus 23.1% with physiological saline | p-value not reported |
The runny nose score measures nasal discharge intensity. The eye score combines eye itching, watering and redness. The quality-of-life questionnaire assesses interference with daily activities, sleep and well-being. Percentages represent decreases in scores from baseline, not proportions of patients cured. P-values show the comparison with physiological saline at the stated time point; a value below 0.001 indicates a statistically significant difference.
Good tolerability observed in this study.
The detailed clinical dossier is available on request under a non-disclosure agreement.
Manufacturing & quality
Certified French manufacturing
Allerspray Urban 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 | PC |
| Public name | Allerspray Urban |
| 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 8 and over |
| Category | Allergic rhinitis associated with environmental pollutants |
| Full official indication | Treatment and prevention of allergic rhinitis caused by environmental pollutants; mild to moderate intermittent allergic rhinitis in adults and children aged 8 and over |
| Composition | Film-forming glycerol, Pollucyanidin-P |
| Format / volume | 15 ml nasal spray, with carton and instructions for use |
| Shelf life before opening | 3 years |
| Storage conditions | Below 25 °C, protected from moisture |
| Shelf life after opening | 1 month |
| Legal manufacturer | Vitrobio SAS |
| Country of manufacture | France, manufactured in-house |
| Quality system | Quality management system certified to ISO 13485 by GMED |
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