Efficacy and tolerability of SEDIFLÙ® in treating dry or productive cough in the paediatric population (SEPEDIA). A pilot, randomized, double blind, placebo-controlled, multicentre clinical trial.

Abstract

Background: Nonpharmacological interventions, such as throat and pharynx demulcents and emollients, are an alternative for cough management and mucosa protection, especially in children, who experience upper respiratory infection-associated acute cough almost four times more than adults. The aim of this trial was to assess the effectiveness of Sediflù®, a medical device containing active herbal ingredients, on nocturnal and diurnal persistent coughs in children, with a duration of 3 to 7 days. Methods: Children with a dry and/or productive cough were enrolled in this prospective, interventional, multicentre, placebo-controlled, double-blind, randomized clinical study. Clinical efficacy was assessed through the evaluation of the soothing action of Sediflù® against dry and/or productive coughing, both at night and during the day and other effects of coughing associated with quality of sleep: frequency, child’s quality of sleep, parental quality of sleep, severity and bothersomeness. Results: Treatment with Sediflù® improved both night- and day-time cough scores from D2. The improvement of the night-time cough score is statistically significantly higher in the Sediflù® group (28% and 71% lower) at D4 and D7, respectively, in comparison to the placebo group (p<0.05). The diurnal score improved significantly in the Sediflù® group (22% and 71% lower) at D3 and D7, respectively, in comparison to the placebo group (p<0.05 and p<0.01, respectively). There was also a significant decrease in the scores of five nocturnal variables associated with sleep quality (frequency, severity, bothersomeness, child’s and parental quality of sleep) from D2, and it was maintained throughout the rest of the days (D3-D7). Considering the inter-group analysis, Sediflù® showed a more significant improvement for frequency, severity, bothersomeness, child’s and parental quality of sleep (70%, 51%, 52%, 58% and 66% lower, respectively) at D7, in comparison to the placebo group (p<0.01). The analysis of a subgroup of children, with cough scores ≥ 3, showed a significant reduction of both frequency and severity scores from the first day of treatment with Sediflù® (p<0.05). Conclusions: Sediflù® syrup can be considered a valid treatment for cough management, especially in younger children with upper respiratory tract infections, shortening the cough duration in children, with a very good safety profile. Trial registration: NEOPS-AEMPS, NEOPS Num 20-0040, Registered 22 December 2020, https://neops.aemps.es/