Abstract

A new generation of multitarget and safe topical pharyngitis treatment for children: Clinical efficacy vs Saline solution

Author(s): Dr. Rémi Shrivastava, Dr. Sayali Sadgune, Mr.Ankit Samadhiya, Mrs. Séverine Dameron

Background: Pharyngitis is the most common disease in children involving viral infection, throat mucosa cellular damage, secondary bacterial infection, inflammation, and broken cellular mucosa integrity. When clinical signs appear, the disease has already become multifactorial where only a multi-target treatment can provide quick relief. In the absence of any multi-target treatment, we conceived a new generation of topical, osmotic, throat surface cleaning polymeric film, capable of detaching and draining throat surface contaminants nearly instantly. The clinical efficacy and safety of this medical device is evaluated in children.

Methods: The test product was conceived by rendering osmotic glycerol filmogen and stable through specific polymeric binding. An observational, randomized, placebo-controlled study was performed after the approval of ethics committee on 30 children aged between 3 to 15, presenting symptoms of acute pharyngitis. After randomization, test product (n=20) and saline control (n=10) solutions were applied as 3 spray to 4 spray on the throat, 2 times to 3 times per day for 15 days. Change in all the key pharyngitis symptoms (difficulty swallowing, throat inflammation, irritation, redness, bacterial deposit, need for antibiotics) were evaluated.

Results: The test product was highly efficient in significantly supressing all the pharyngitis symptoms vs comparator product within 3 days of treatment. The need for antibiotics was drastically decreased and no adverse effects were noticed during the study.

Conclusions: 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 for the treatment of pharyngitis in children. This mechanically acting, multi-target, new generation of polymeric drugs can help reduce the problem of antibiotic resistance and long-term side effects of currently used pharyngitis drugs in children.