CLINICAL TRIALS PROFILE FOR HYDROCORTISONE; NEOMYCIN SULFATE

All Clinical Trials for hydrocortisone; neomycin sulfate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05999955 ↗	Safety and Efficacy of DSM 32444 Postbiotic in the Treatment of Acute Rhinosinusitis	Completed	Vietstar Biomedical Research	N/A	2022-12-29	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.
NCT05999955 ↗	Safety and Efficacy of DSM 32444 Postbiotic in the Treatment of Acute Rhinosinusitis	Completed	Huro Biotech Joint Stock Company	N/A	2022-12-29	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.

Clinical Trial Conditions for hydrocortisone; neomycin sulfate

Condition Name

Condition Name for hydrocortisone; neomycin sulfate
Intervention	Trials
Rhinitis	1
Rhinosinusitis	1

Condition MeSH

Condition MeSH for hydrocortisone; neomycin sulfate
Intervention	Trials
Sinusitis	1
Rhinosinusitis	1
Rhinitis	1

Clinical Trial Locations for hydrocortisone; neomycin sulfate

Trials by Country

Trials by Country for hydrocortisone; neomycin sulfate
Location	Trials
Vietnam	1

Clinical Trial Progress for hydrocortisone; neomycin sulfate

Clinical Trial Phase

Clinical Trial Phase for hydrocortisone; neomycin sulfate
Clinical Trial Phase	Trials
N/A	1

Clinical Trial Status

Clinical Trial Status for hydrocortisone; neomycin sulfate
Clinical Trial Phase	Trials
Completed	1

Clinical Trial Sponsors for hydrocortisone; neomycin sulfate

Sponsor Name

Sponsor Name for hydrocortisone; neomycin sulfate
Sponsor	Trials
Huro Biotech Joint Stock Company	1
Vietstar Biomedical Research	1

Sponsor Type

Sponsor Type for hydrocortisone; neomycin sulfate
Sponsor	Trials
Industry	2

Hydrocortisone; neomycin sulfate Market Analysis and Financial Projection

Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate: Clinical Trials, Market Analysis, and Projections

Introduction

The combination of hydrocortisone, neomycin sulfate, and polymyxin B sulfate is a widely used otic suspension for treating infections of the external auditory canal. This article delves into the clinical trials, market analysis, and future projections for this drug combination.

Clinical Trials Overview

Comparative Studies

Several clinical trials have compared the efficacy and safety of hydrocortisone; neomycin sulfate; polymyxin B sulfate otic suspension with other treatments. A notable study compared this combination with topical ciprofloxacin 0.3%/dexamethasone 0.1% (CD) otic suspension for the treatment of acute otitis externa (AOE)[3].

• Methodology: The study involved two institutional review board-approved, multicenter, observer-masked, parallel-group, randomized, noninferiority clinical trials. Patients were randomly assigned to receive either CD or the hydrocortisone; neomycin sulfate; polymyxin B sulfate (PNH) otic suspension for 7 days.
• Results: The study found that the time to cure was significantly less with CD compared to PNH, with mean times to cure of 9.7 days for CD and 10.3 days for PNH. However, both treatments showed high cure rates and similar adverse event profiles.

Another study compared once-daily ofloxacin otic solution with the traditional four-times-daily hydrocortisone; neomycin sulfate; polymyxin B sulfate otic suspension in children with otitis externa (OE)[4].

• Methodology: This multicenter, randomized, parallel-group, evaluator-blinded study involved 278 pediatric patients. Patients received either once-daily ofloxacin otic solution or four-times-daily hydrocortisone; neomycin sulfate; polymyxin B sulfate otic suspension for 7-10 days.
• Results: The study found equivalent cure rates between the two treatment groups, with both providing rapid and comparable pain relief. However, the ofloxacin otic solution had the advantage of not carrying the risk of ototoxicity associated with neomycin.

Bioequivalence Studies

For generic versions of hydrocortisone; neomycin sulfate; polymyxin B sulfate otic suspension, the FDA requires bioequivalence studies to ensure the generic product is as effective and safe as the reference listed drug (RLD)[1].

• Design: These studies typically involve randomized, double-blind, parallel, placebo-controlled designs. Patients with superficial bacterial infections of the external auditory canal are treated with either the test product, the RLD, or a vehicle (placebo) control.
• Endpoints: The primary endpoints include the proportion of subjects with clinical cure and the time to end of pain, evaluated at the test of cure visit 7 to 14 days after the end of treatment.

Market Analysis

Market Size and Growth

The market for neomycin sulfate, a key component of the hydrocortisone; neomycin sulfate; polymyxin B sulfate combination, is significant and growing.

• Current Market Size: The global market size of neomycin sulfate was approximately 13 thousand tonnes in 2023[2].
• Growth Projections: The market is anticipated to grow at a CAGR of 3.5% until 2034, driven by increasing demand for antimicrobial treatments.

Regional Demand

North America is the leading consumer of neomycin sulfate, reflecting a high demand for otic suspensions in this region[2].

Market Projections

Future Demand

The demand for hydrocortisone; neomycin sulfate; polymyxin B sulfate otic suspension is expected to remain strong due to its efficacy in treating common infections like otitis externa.

• Increasing Incidence of Infections: The incidence of external ear infections is likely to continue, driven by factors such as increased exposure to water activities and rising antibiotic resistance.
• Generic Market: The approval of generic versions, as facilitated by FDA guidelines, will increase market competition and potentially lower prices, making the treatment more accessible to a broader population[1].

Regulatory Environment

The FDA's determination that Cortisporin (hydrocortisone; neomycin sulfate; polymyxin B sulfate) otic solution was not withdrawn from sale for reasons of safety or effectiveness ensures continued regulatory support for this drug combination[5].

Safety and Efficacy Considerations

Ototoxicity Concerns

Neomycin, a component of the combination, carries a risk of ototoxicity, which can be a significant concern. Alternative treatments like ofloxacin otic solution, which do not have this risk, may gain preference in certain cases[4].

Clinical Observations

Close clinical observation is necessary, especially for neomycin-associated sensorineural hearing loss. Patients who do not respond to therapy within 48 hours may require standard therapy as per the early escape clause in clinical trials[1].

Key Takeaways

• Clinical Efficacy: Hydrocortisone; neomycin sulfate; polymyxin B sulfate otic suspension is effective in treating otitis externa, though it may have slightly longer cure times compared to some newer treatments.
• Market Growth: The market for neomycin sulfate is growing, driven by increasing demand for antimicrobial treatments.
• Regulatory Support: FDA guidelines support the continued use and approval of generic versions of this drug combination.
• Safety Considerations: The risk of ototoxicity associated with neomycin necessitates careful clinical monitoring.

FAQs

Q: What is the current market size of neomycin sulfate in terms of volume?

A: The global market size of neomycin sulfate was approximately 13 thousand tonnes in 2023[2].

Q: Which region is the leading consumer of neomycin sulfate?

A: North America is the leading consumer of neomycin sulfate globally[2].

Q: What are the primary endpoints in bioequivalence studies for hydrocortisone; neomycin sulfate; polymyxin B sulfate otic suspension?

A: The primary endpoints include the proportion of subjects with clinical cure and the time to end of pain, evaluated at the test of cure visit 7 to 14 days after the end of treatment[1].

Q: Is hydrocortisone; neomycin sulfate; polymyxin B sulfate otic suspension safe for use in children?

A: Yes, but it must be used under medical supervision due to the risk of ototoxicity associated with neomycin. Alternative treatments like ofloxacin otic solution may be preferred in some cases[4].

Q: What is the projected growth rate of the neomycin sulfate market until 2034?

A: The market is anticipated to grow at a CAGR of 3.5% until 2034[2].

Sources

1. FDA Guidance on Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate Otic Suspension/Drops. FDA.
2. Neomycin Sulphate Market Size, Share, Growth & Forecast. ChemAnalyst.
3. Pooled analysis of two clinical trials comparing the clinical outcomes of patients receiving topical ciprofloxacin 0.3%/dexamethasone 0.1% (CD) otic suspension with those receiving polymyxin B/neomycin/hydrocortisone (PNH) otic suspension for the treatment of acute otitis externa (AOE). PubMed.
4. Once-daily ofloxacin otic solution versus neomycin sulfate/polymyxin B sulfate/hydrocortisone otic suspension in children with otitis externa. PubMed.
5. Federal Register/Vol. 84, No. 65/Thursday, April 4, 2019/Notices. GovInfo.