At a glance
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An Open-label, Randomized, Active-controlled Study to Evaluate the Safety of Postbiotic Nasal Spray Using Inactivated DSM32444 Spores in the Treatment of Acute Rhinosinusitis, as Compared With Neomycin/ Dexamethasone/Xylometazoline Spray
In Brief
A clinical study evaluating Neomycin/ Dexameythasone/Xylometazoline and Bacillus subtilis DSM32444 for Rhinosinusitis and Rhinitis. Completed, enrolled 60 participants across 1 site.
Detailed Summary
Rhinitis is a type of upper respiratory infection with a common nasal pathology especially in Southeast Asia, which is characterized by the presence of one or more of the following symptoms: itchy nose, sneezing, runny nose, and nasal congestion. Other symptoms occasionally experienced include headache, excessive pain reaction, cough, fever. Rhinitis can be idiopathic or due to a variety of causes, including allergens, medications, endocrine/metabolic, infectious, inflammatory, and abnormal nasal structures. The treatment of acute rhinosinusitis and allergic rhinitis in hospitals is currently carried out according to the general professional guidance of the Vietnam Ministry of Health. Most patients are prescribed corticosteroids, antihistamines, and antibiotics for immediate decongestion and anti-inflammatory effects. Current concerns about antimicrobial resistance (AMR) as well as side effects of corticosteroids and antihistamines have led to an urgent need for a naturebased next generation therapeutic approach that is safe, effective and helps in addressing the issues of AMR. The goal of this interventional study is to evaluate the safety and efficacy of postbiotic nasal spray using inert bioparticles of Bacillus subtilis DSM32444 in treatment of acute rhinosinusitis; and to compare the efficacy against Neomycin/Dexamethasone//Xylometazoline administered as a nasal spray as an adjunct to Amoxicillin/Clavulanate standard treatment in patients with acute rhinosinusitis. Patients with acute rhinosinusitis who give consent to participate in the study will be randomly assigned in a 1:1 ratio to one of two groups using postbiotic of Bacillus subtilis DSM32444 nasal spray ("Sperovid") or Neomycin/ Dexamethasone nasal spray for a period of 10 days. Investigators will compare whether the nasal spray using postbiotic Bacillus subtilis DSM32444 has similar efficacy as compared to Neomycin/Dexamethasone/Xylometazoline nasal spray as an adjuvant therapy along with the standard Amoxicillin/Clavulanate regimen in patients with acute rhinosinusitis based on time to improvement of rhinosinusitis symptoms.
Study Details
Timeline
Interventions
The active-control in the phase II study was a commercial form of nasal spray containing Dexamethasone/Neomycin/Xylometazoline. This formulation is approved by Vietnam's Ministry of Health as a treatment regime for rhinosinusitis. Dexamethasone sodium phosphate is fluoromethyl prednisolone, a synthetic glucocorticoid. Dexamethasone has the main effects of glucocorticoids as anti-inflammatory, antiallergic and immunosuppressant. Neomycin sulfate is an antibiotic belonging to the group of aminoglycosides that have a bactericidal mechanism due to inhibition of bacterial protein biosynthesis. In this study, the nasal spray is used as an adjunct to Amoxicillin/Clavulanate standard treatment
Postbiotic DSM32444 is manufactured by HURO BIOTECH Company as a drug-grade active pharmaceutical ingredient. The Class A medical device containing Postbiotic DSM32444 is called Sperovid, which is manufactured by Dong Duoc Viet under ISO 13485:2016 standards for medical device. Sperovid has registration number: 220000033/ PCBALA In this study, the nasal spray is used as an adjunct to Amoxicillin/Clavulanate standard treatmen.