Abstract

Treating acute and chronic rhinosinusitis in children using an osmotic, nasal surface cleaning, non-medicated polymeric film

Author(s): Rémi Shrivastava, Ravi Shrivastava, Megha Vijay, Savali Sadgune, Sandeep Kumar

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, non-irritant, topically applicable, and safe filmogen solution can be considered a breakthrough for the treatment.