Sediflù Syrup Effective and Safe for Managing Pediatric Cough, Study Finds

Coughing, a common symptom of upper respiratory tract infections (URTIs), significantly impacts children’s quality of life, often disrupting sleep and causing distress. URTIs, highly recurrent in children, can lead to persistent coughs lasting beyond three days, requiring effective management to relieve symptoms without hindering natural recovery.

SEDIFLÙ syrup, a medical device combining natural ingredients like eucalyptus honey and herbal extracts, offers a dual action: mucolytic effects for productive coughs and a demulcent effect for dry coughs. By forming a protective barrier, increasing saliva production, and reducing inflammation, it soothes mucosa and alleviates the cough reflex, promoting faster symptom relief.

Against the above background, Ester Risco, Unitat de Farmacologia, Farmacognòsia i Terapèutica, Facultat de Farmàcia, Universitat de Barcelona, Barcelona, Spain, and colleagues aimed to evaluate the efficacy of Sediflù, a medical device formulated with active herbal ingredients, in managing nocturnal and diurnal persistent coughs in children lasting 3 to 7 days.

For this purpose, the researchers conducted a prospective, interventional, multicenter, placebo-controlled, double-blind, randomized clinical study involving children with dry and/or productive coughs. The study assessed the clinical efficacy of Sediflù by evaluating its soothing effects on coughing during both day and night. Additionally, the researchers examined the impact of coughing on sleep-related outcomes, including cough frequency, the child’s sleep quality, parental sleep quality, and overall symptom severity.

Study Results on Sediflù Efficacy and Safety

Baseline Characteristics

• 60 children with dry/productive cough were recruited; 56 completed the study (Sediflù: 27, Placebo: 29).
• Mean age: 8.65 years.
• Gender distribution: 53% boys, 47% girls.

Efficacy of Sediflù

1. Cough Scores
   • Significant reduction in night-time and day-time cough scores in the Sediflù group from Day 2 (D2) to Day 7 (D7) than baseline.
   • Sediflù group had a 28%-71% lower night-time scores and 22%-71% lower day-time scores than the placebo group across D3-D7.
2. Sleep-Related Variables
   • Nocturnal variables (frequency, severity, bothersomeness, child and parental sleep quality) were significantly improved from D2 to D7.
   • By D7, Sediflù reduced frequency by 89%, severity by 87%, and bothersomeness by 87% compared to baseline.
   • Child’s sleep quality improved by 89%, and parental sleep quality by 92%.
3. Severe Cough Subgroup
   • There were significant reductions in frequency and severity scores from D1 in children with severe cough.
   • At D7, Sediflù showed 51%-70% improvement across all variables compared to placebo.

Safety

• No adverse effects were observed in either group.

The study showed that Sediflù syrup effectively alleviates disturbances associated with day-time and night-time cough, significantly reducing cough severity and frequency from the first day of treatment. It also shortens the duration of coughs in children while demonstrating an excellent safety profile.

"These results support Sediflù as a reliable treatment option for managing cough, particularly in younger children with upper respiratory tract infections. Its efficacy is attributed to the formation of a protective mechanical barrier on the oropharyngeal mucosa, combined with complementary physicochemical effects," the researchers concluded.

Reference:

Núñez C, Chiatti MC, Tansella F, Coronel-Rodríguez C, Risco E. Efficacy and tolerability of SEDIFLÙ in treating dry or productive cough in the pediatric population (SEPEDIA): A pilot, randomized, double-blind, placebo-controlled, multicenter clinical trial. Clin Pediatr (Phila). 2024 Nov;63(11):1510-1519. doi: 10.1177/00099228241228074. Epub 2024 Feb 7. PMID: 38323572; PMCID: PMC11468240.