NSE (Kids) : Rapid and Effective Relief for Rhinosinusitis in Children
The NSE (Kids) product from Vitrobio is an innovative nasal spray designed for the treatment of rhinosinusitis, rhinitis, and nasal congestion in children over 3 years old. It works by creating a filmogenic liquid bandage on the nasal mucosal surface, providing hydration, cleansing, and reducing contaminants and pro-inflammatory proteins through osmotic action. Clinical trials have shown a 20% reduction in nasal congestion within 2 hours.
Introducing NESOSPRAY-E Kids
Vitrobio presents NESOSPRAY-E Kids , a pioneering solution specifically designed for the treatment of rhinosinusitis, rhinitis, and nasal congestion in children over 3 years old. This product is a nasal spray in a convenient 15 ml format, designed for easy application and optimal delivery of the active components.
Mode of action
- Protective Barrier Effect: NESOSPRAY-E Kids works by creating a filmogenic liquid bandage on the nasal mucosal surface. This protective barrier shields the nasal mucosa from further irritation or infection, providing an immediate layer of defense.
- Osmotic Action: The spray also exerts an osmotic action, which attracts fluids towards the exterior, helping to massively unblock congested sinuses. This osmotic action also cleanses the nasal mucosa by effectively drawing out contaminants, debris, and pro-inflammatory proteins such as cytokines and interleukins. This dual action of unblocking and cleansing provides immediate relief and creates a clean environment conducive to healing.
- Cellular Repair and Growth Effect: With the nasal mucosa now in a clean and protected state, the healing process can effectively begin. The spray promotes cell growth and repair, allowing the nasal mucosa to regenerate and regain its integrity. This restoration of the nasal mucosa is crucial for long-term relief from rhinosinusitis, rhinitis, and nasal congestion.
Clinical Trials and Results
The effectiveness of NESOSPRAY-E Kids spray has been evaluated in a randomized, double-blind clinical trial against a placebo, conducted over 2 weeks with 20 patients. The trial included patients with rhinosinusitis, encompassing all symptoms related to this condition.
The main results of the trial were highly promising. There was a 20% reduction in nasal congestion within 2 hours after application.
In conclusion, NESOSPRAY-E Kids reresents a significant advancement in the treatment of rhinosinusitis, rhinitis, and nasal congestion in children. Its unique mechanism of action, combined with its ease of use and rapid results, make it a promising addition to the therapeutic options available for these common pediatric conditions.
Understanding Rhinosinusitis, Rhinitis, and Nasal Congestion in Children
Rhinosinusitis, rhinitis, and nasal congestion are common health issues that can significantly affect children’s comfort and quality of life. These conditions are characterized by inflammation and swelling in the nose and sinuses, leading to symptoms such as a runny or stuffy nose, sneezing, and facial pain or pressure.
Causes and Symptoms of Rhinosinusitis, Rhinitis, and Nasal Congestion
These conditions can be caused by various factors, including common cold, viral infections (like the common cold), allergies, and environmental irritants. In children, these conditions can also be exacerbated by factors such as exposure to secondhand smoke or changes in weather.
The symptoms of rhinosinusitis, rhinitis, and nasal congestion can be particularly bothersome for children, affecting their sleep, appetite, and ability to concentrate in school. These symptoms can also lead to other complications, such as ear infections or sinusitis, if not properly treated.
Treatment for Rhinosinusitis, Rhinitis, and Nasal Congestion in Children
Treatment for these conditions typically involves managing the symptoms and addressing the underlying cause. This can include the use of over-the-counter remedies, prescription medications, and in some cases, lifestyle changes or procedures. It’s important for parents to consult with a healthcare provider to determine the best course of treatment for their child.
Prevention of Rhinosinusitis, Rhinitis, and Nasal Congestion in Children
Prevention strategies include regular hand washing, avoiding known allergens, and maintaining a healthy indoor environment. Regular check-ups with a healthcare provider can also help detect and manage these conditions early.
Rhinosinusitis, rhinitis, and nasal congestion can significantly impact a child’s wellbeing. Understanding these conditions, their causes, symptoms, and treatment options can help parents and caregivers provide the best care for their children. With the right treatment, such as the NSE (Kids) nasal spray, children can find relief from these common conditions and enjoy a better quality of life.
CLAIMS IN LINE WITH THE NEW REGULATION
- Mechanical mode of action
- Instant osmotic action
- Clears, decongests and cleanses the sinuses
- Dual action: Relieves and protects
- Reduces contaminants on the nasal surface
- Reduces nasal congestion, sinus pain (<2h)
- Reduce all the rhinosinusitis symptoms
- No drowsiness . No habituation effect
- Fast action
RHINOSINUSITIS (KIDS) Randomized, double-blind clinical trial
Title : Treating acute and chronic rhinosinusitis in children using an osmotic, nasal surface cleaning, nonmedicated polymeric film
Published: 31-Dec -2022; DOI: 10.37532/2041-6792.2022.12(12).238-247
Objective: Acute and chronic rhinosinusitis is one of the most common diseases in children,
affecting seriously the quality of life of children and parents. The physiopathology is multifactorial involving nasal mucosa inflammation, cellular damage and blocked sinus drainage due to bacterial biofilm on sinus openings. Currently, there are no multi-target treatments available, and nothing is discovered yet to open and drain the blocked sinuses. We evaluated the clinical efficacy of a new generation of multi-target, non-irritant, osmotic, safe, polymeric glycerol film for the treatment of rhinosinusitis in children.
Methods: A 15-day, randomized, placebo-controlled, double-blind, efficacy and safety clinical study was conducted on 20 children in a test product group and 10 in a saline solution comparator group. The children were aged between 3 years to 16 years old and had rhinosinusitis symptom severity score>25/50 at baseline. 2 nasal sprays-3 nasal sprays were applied 3 times to 4 times per day consequently for 15 days. Effects on rhinorrhoea or congestion, fever, cough, sleep, and facial pain were recorded at baseline, 2 h after 1st treatment, and on days 1 (visit 1), 3 (visit 2), 6 (visit 3), and 15 (visit 4). The need for antibiotics and adverse effects were also noted.
Results: The test product as well as saline solution nasal washes reduced rhinosinusitis symptoms, but the reduction was much faster and stronger in the test group compared to the comparator group. Nearly 50% of symptomatic relief was seen within 3 days with test product vs 10 days to 15 days for saline solution and all the patients in the test product group recovered by day 15. Compared to 40% of children in the comparator group, no patients in the test product group required rescue antibiotics therapy. Both products were non-irritant and safe as no adverse effects were observed.
Conclusion: In the absence of any treatment to open and drain the sinuses and act on multiple
factors involved in children’s rhinosinusitis; using a topical multi-target, instant nose cleaning,
applicable, and safe filmogen solution can be considered a breakthrough for the treatment.
|Indication||Filmogen liquid bandage for the treatment of rhinosinusitis, rhinitis and nasal congestion in children.|
|Composition||Filmogenic glycerol, solagum, water, association of Vaccinum macrocarpon, Vaccinum myrtillus, Sambucus nigra, Ribes nigrum and Potassium -Sodium - Acid citric.|
|Presentation||Nasal spray 15ml|
|Class||MDD Class I | MDR Class IIa|
|Direction||Apply 2 sprays in each nostril, 2-3 times a day.|
|Precautions||For topical use only (nasal cavity).|
|Storage conditions||Below 25°C|
|Legal manufacturer||VITROBIO (France)|