Abstract

Clinical efficacy and safety of a long-acting osmotic nasal filmogen spray for the treatment of rhinosinusitis

Author(s): Rémi Shrivastava1*, S. DAMERON1, J. IEHL1, Megha VH2, Deepti Shrivastava3, Marius ALBINO4

Objective: Rhinosinusitis is the most common diseases affecting nearly 10%-15% world population. The
physiopathology is multifactorial involving nasal mucosa inflammation, cellular damage, and obstruction
of sinus drainage due to bacterial biofilm on the sinus openings. Currently available chemical or biological
treatments are mono-target and may have serious side effects in sensitive population. We evaluated the
clinical efficacy of NESOSPRAY HE-G nasal spray, a new generation of safe, multi-target, non-irritant, osmotic,
polymeric glycerol film for the treatment of rhinosinusitis in adults, including pregnant women, against
placebo spray as control.
Methods: A 15-day, randomized, placebo-controlled, double-blind, efficacy and safety clinical study was
conducted in 12 males and 8 females in the placebo group and 9 males and 11 females in NESOSPRAY HE-G
group, with 7+7 pregnant women in each group suffering from acute rhinosinusitis. 2 nasal sprays
were applied 3 to 4 times a day for 15 consecutive days. Effects on rhinorrhoea or congestion, fever,
cough, sleep, and facial pain were recorded at baseline, 2 h after 1st treatment, and on day 1, 2, 3, 6 and 15.
The need for antibiotics as well as adverse effects was also recorded.
Results: Both NESOSPRAY HE-G and nasal rinses with placebo spray reduced rhinosinusitis symptoms, but
the reduction was much faster and stronger in the test group compared to the placebo group. The
efficacy of NESOSPRAY HE-G treatment was highly significant vs placebo on all parameters right from
day 2. Due to the rapidity of effects of NESOSPRAY HE-G, only 1/20 patients in this group required
antibiotherapy vs 15/20 in the placebo group. No adverse effects were observed, including in pregnant
women.
Conclusions: To avoid the use of chemical, biological, and mono-target drugs for the treatment of rhinosinusitis,
a mechanically acting, totally safe, rapid and multi-target treatment represents a breakthrough
discovery for the treatment of rhinosinusitis in both adults and childbearing women.