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.

Background: Pollution induced allergic rhinitis and respiratory symptoms is becoming a major health problem in the world for which still there is no safe and preventive treatment. Objectives: Conceive and evaluate the allergen preventive properties and clinical efficacy of an osmotic, polymeric, stable filmogen spray, called PCNS. Materials and Methods: Amb A 1 (ragweed), Der P 1 and 2 (dust mite), Bet v 1 (birch), Alt a 1 (Alternaria, fungus), and Fel d 1 (cat dander) allergens were exposed at a concentration of 5µg/ml (20 µl per tube) on the polymeric test product film (120 and 240µl layer) and the allergens crossing the barrier were quantified in the agar gel beneath the film. 0.40% HPMC and PBS solutions, tested identically, served as controls. Clinical efficacy of PCNS nasal spray was evaluated in patients suffering from allergic rhinitis and/or respiratory symptoms (29 in test product v/s 15 in saline controls) for 22 days. Nasal, ocular, respiratory symptoms and Rhino conjunctivitis Quality of Life Questionnaire (RQLQ) were measured. Statistical analyses: The normality of the populations was determined by the Shapiro-Wilk test, then statistical analysis was performed by two-tailed Student’s test for comparisons between two groups and the two-way ANOVA followed by the post hoc Bonferroni’s test for comparisons of multiple groups. p<0.05 was considered statistically significant. The analyses were performed with the software GraphPad Prism (version 8.4.2, La Jolla, USA). NS indicates not significant. Results: PCNS polymeric spray blocked the diffusion of all the allergens while 0.40% HPMC was able to prevent diffusion of only Alt a 1 and Fel d 1 allergens. Mean reflective total nasal symptom scores (rTNSS), reflective total ocular symptom score (rTOSS), and respiratory symptoms including effect on wheezing, cough, dyspnea, and chest tightness were moderately improved in the control saline group, but the improvements were nearly twice better in the PCNS group. RQLQ was improved by 23% in saline spray v/s 46% PCNS group. 4/15 patients in saline group v/s 1/29 in PCNS group required rescue medication during the study. PCNS was highly effective in reducing allergen and pollution induced respiratory symptoms. Conclusion: a polymeric, osmotic, and stable nasal barrier against pollutants and allergens represents an innovative approach against pollution induced respiratory symptoms.

BACKGROUND The efficacy and safety of Mig-RL (Commercial name HERBA MIG), a synergistic association of two plant extracts, Tanacetum parthenium (150mg, 0.5% parthenolide) and Salix Alba (150mg, 25% salicin) were investigated as a preventive treatment for episodic migraine. Mig-RL was compared with a placebo in a randomized, double-blind clinical trial. MATERIALS AND METHODS This trial included 129 patients having episodic migraine and diagnosed with migraines without aura for over a year and meeting the migraine criteria, as defined in the International Classification of Headache Disorder (ICHD-3 :1.1). P). Baseline data was collected for 28 days before the start of the three-months treatment period. Patients were randomized in a 1:1 ratio to receive either Mig-RL (a single dose of 300mg per day, per os) or placebo (identical capsules containing 300 mg starch, 1 per day, per os) for a period of 12 consecutive weeks. The primary endpoint was the mean change in the average number of migraine days per month, comparing the baseline 28-days pre-intervention period with the weeks 9 to 12 after the first dose of the trial regimen. Secondary endpoints were the percentage of patients with a reduction of at least 30% in the average number of migraine days per month and days of use of any acute headache medication per month. The HIT-6 and MIDAS scores were also evaluated vs. baseline between the two groups. RESULTS Out of 172 patients enrolled, 129 were randomly assigned to the Mig-RL arm (n=65) or the placebo arm (n=64). The mean (±SD) number of baseline migraine days per month was 8.4±1.9 and 8.7±1.9, respectively. The mean reduction in the average number of migraine days per month was 2.5±0.4 (p<0.001) with Mig-RL and 1.9±0.4 (p<0.001) with placebo. A difference of 0.6±0.4 (p=0.01) between the two groups. The percentage of patients with at least 30% reduction in average number of migraine days per month was 49% in Mig-RL and 32% in placebo (p<0.05 vs. placebo). Only a few isolated and minor side effects were reported and overall Mig-RL was well tolerated by patients. CONCLUSIONS Mig-RL, a synergistic combination of two plant extracts, seems to have a moderate effect in the prevention of migraines. Without side effects, the combination of Tanacetum parthenium and Salix alba could be an additional help for some patients. However, further investigations and an improvement in the quality of the plants are still necessary.