Cough spray – Kids


Coughing in kids:

Coughing in kids is slightly different than in adults. The “big 3” causes of cough in adults (asthma, post-nasal drip & gastroesophageal reflex) are far less common in kids where coughing is mostly related to an infection. The throat mucosa is fragile & sensitive in children. Virus growth & secondary bacterial infections are faster. Coughing is often accompanied by fever, nasal discharge, acid reflux, fatigue & poor sleep in kids.
In fact, coughing is a healthy & important reflex that helps protect the airways in the pharynx & chest. Therefore, coughing should not be suppressed but the cause(s) of coughing (viruses & bacteria on the throat, sticky mucus, dry surface, nasal irritation & inflammation) should be removed to stop the coughing reflex.

An Ideal treatment:

The commonly used cough medications in adults (anti-histamines, codeine, corticosteroids) are not recommended for children as their benefit/risk ration is too poor. To stop the coughing reflex, it is therefore essential to stop viral growth, detach & remove bacterial contaminants, humidify & fluidify the throat mucosa. Children being fragile, an ideal treatment should act topically to avoid side effects & it should have a good taste.

Class I Medical Device: 20mL Sprays For the treatment of Cough in chidren


Currently available treatments:

There is no multi-target & safe cough treatment for children (3-15 years) yet. All the currently available treatments are symptomatic, such as antitussives (centrally acting such as opioids, codeines, morphine), non-opioids (such as anticholinergic Benzonatate), and acting on only one of the parameters involved in coughing. These are symptomatic drugs and have multiple side effects such as addiction, nausea, drowsiness, headache & sedation. Therefore, they are not appropriate to treat cough in children.

VITROBIO’s Completely NEW therapeutic Approach:

The aim of VITROBIO’s research was to find a multi-target, fast-acting, throat-cleaning, topical & safe treatment which is adapted for children.

In 1994, Vitrobio discovered & patented a hypertonic viscous liquid solution, based on Glycerol: VB-Gy, 18 times more osmotically active than sea water yet NON-IRRITANT, capable of generating an instant flow of hypotonic liquid when applied on a live biological, semi-permeable, membrane (International patent 1997: PCT/FR99/01340). Applying this solution on the throat surface, creates a strong outward flow of hypotonic liquid fluidifying the dry throat surface (DRY cough) or diluting the thick & viscous mucus adhered to the throat surface (WET cough) thereby normalizing throat surface hydration. A new patent on the film retention properties of VB-Gy solution was recently filed (N° PCT/EP2013/061835).

Mode of action:

When sprayed on the throat surface, COUGH SPRAY-KIDS forms an osmotically active film over the throat mucosa, that mechanically attracts hypotonic fluid from the deeper parts of the throat. This constant liquid exudation liquefies the mucus and facilitates its natural expelling. This strong outward flow of liquid detaches and removes all the free-floating contaminants present on the throat surface (bacteria, free virus particles, dust particles, dead cells, cell debris) and any other particle so as to clean the throat surface. The viscous nature of the film protects the throat surface from irritation and external aggressions, reducing pain and cough. The product acts as a mechanical antiseptic and cleaning solution. By applying the product at the beginning of the infection, COUGH SPRAY-KIDS stops the propagation of the infection and acts as a preventive measure. (For detailed mode of action: please contact Vitrobio)

Product Presentation: 20 mL Spray

Posology: 3-4 sprays per application, 3-4 times a day, until complete recovery.

Regulatory Status: Due to the mechanical topical filmogen activity without any pharmacological, biological, metabolic or immunological interaction with the cellular structure:  Class I Medical Device in Europe.

Contrindications: Not to be used in pediatric population under 3 years of age.

Side Effects: This product has no known side effects.

Clinical Efficacy:

A comparative, randomized, double-blind, parallel group, observational clinical trial study was conducted at Malons Multispeciality Hospital and ICU (Navi Mumbai/India) to evaluate the efficacy and safety of Vitrobio’s cough spray for kids versus 0.9% NaCl saline solution spray in the treatment of cough. Dates of the study: 18/09/2018-26/10/2018. 30 patients aged 3-15 years old. Study number: COU/OBS/2018. The results of the study clearly show that the test product improves significantly all the cough parameters measured in the study (cough frequency / severity, cough night disturbance, chest discomfort, throat irritation and fever.)