Clinical efficacy and safety of the 1st non-medicated, safe, and nearly instant cough treatment for children

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Abstract

Background: Acute and chronic coughs are the most frequent pathologies in children and are closely associated with recurrent epidemics
of Covid-19. This is a multi-factorial disease, involving viral infection, broken throat mucosa integrity, secondary bacterial infection,
inflammation and excessive mucus production, responsible for triggering cough reflex. When clinical signs appear, the disease has already
become multifactorial, only a multitarget treatment can provide quick relief. In the absence of any multitarget treatment, we conceived a
new generation of topical, osmotic, throat surface-cleaning polymeric film, capable of cleaning the throat surface and fluidizing mucus,
nearly instantly. The clinical efficacy and safety of this medical device compared to saline solution are evaluated in kids.
Methods: The test product contained a glycerol-based, mechanically resistant, osmotic, polymeric film solution for application on the throat
surface. An observational, randomized, placebo-controlled study was performed after Ethics Committee approval on 30 children aged 3
to 15, presenting symptoms of acute and/or chronic cough. After randomization, test product (n=20) and saline control (n=10) solutions
were applied as 3-4 sprays 4-5 times/day for 15 days. Changes in all the key cough symptoms (cough frequency, throat irritation, sleep
disturbances, chest discomfort) as well as effect on the quality of life and need for anti-biotherapy were compared against saline solution
treatment.
Results: The test product was highly efficient in significantly suppressing all the cough symptoms vs the comparator product within 3 days
of treatment. The need for antibiotics was drastically decreased and no adverse effects were recorded during the study.
Conclusion: Detaching and draining all the free-floating throat surface contaminants with a nearly instant, polymeric osmotic film, without
the use of any chemical drug, represents a totally new approach to the treatment of cough in children. This mechanically acting, multitarget,
new generation of polymeric drugs can help reduce the problem of antibiotic resistance and long-term side effects of currently used
chemical cough treatments in children.

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