Journal of Clinical Trials
Open Access

Abstract

Clinical Efficacy of Novel Filmogen, Antimicrobial, Cleaning, Fluidizing Cough Treatment

Remi Shrivastava, Frédéric Carrois, Mehmet Pisak, Thomas Chabrillat and Ravi Shrivastava

Objective: Cough reflex is the body’s protective mechanism to prevent entry of foreign material into the lower respiratory tract. Cough is usually caused by a primary viral infection: virus growth causes lysis of throat mucosa cells, leading to inflammation, secondary bacterial infection, accumulation of contaminants on the throat, increased mucus secretion, and coughing. To treat this multifactorial condition, an effective treatment should be multitarget, but no currently available drug fulfils this complex yet essential requirement. We developed a hypertonic, highly osmotic, filmogen liquid bandage which can mechanically clean the throat surface. A clinical trial was conducted to evaluate its efficacy and safety.

Methods: A 14-day, randomized, placebo-controlled, double blind, efficacy and safety study was conducted on 37 treated vs. 17 comparator (saline solution) patients suffering from dry cough. Products were applied as spray, 3-4 times daily, for maximum 14 days, and cough-related parameters were evaluated on days 1, 2, 3, 6, 9, 12, and 14.

Results: Compared to the comparator product, test product triggered an instant and strong reduction in the mean scores of dry cough severity and frequency, and consequently in throat pain, irritation, swelling, and redness, with remarkable improvement in Leicester cough questionnaire parameters. Test product proved as safe as the comparator product.

Conclusions: Cleaning the throat surface and fluidizing mucus using a new generation of liquid throat bandages opens new therapeutic horizons for the treatment of severe cough.