Ignite Creation Date:
2024-05-06 @ 1:16 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03975257
Status:
COMPLETED
Last Update Posted:
2019-12-10
First Post:
2019-01-22
Brief Title:
Ectoin Lozenges EHT02 in the Treatment of Oropharyngeal Allergic Symptoms
Sponsor:
Bitop AG
Organization:
Bitop AG
Study Overview
Official Title:
Application of Ectoin Lozenges EHT02 in Patients With Oropharyngeal Allergic Symptoms
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this multicentric prospective randomised controlled study 23b German Act on Medical Devices MPG is to investigate the efficacy of Ectoin Lozenges EHT02 in treatment and prevention of oropharyngeal allergic symptoms
Detailed Description:
The immune system of humans can show an overreaction to proteins from the environment allergic reaction Triggers of these allergic reactions may be eg pollen dust mites mold or animal hair Common allergic symptoms include itchy stuffy runny nose sneezing itchy and watery eyes and respiratory complaints Allergen-specific immunotherapy is the only treatment that eliminates the causes of allergic disease An example of such immunotherapies is the sublingual immunotherapy SLIT During SLIT side effects may occur such as local oropharyngeal reactions eg manifesting as itching swelling or irritation
The current study aims to investigate the efficacy of Ectoin Lozenges EHT02 in patients suffering from oropharyngeal allergic symptoms The symptoms are induced by SLIT
Patients are dedicated to one of three groups a preventive application of Ectoin Lozenges before SLIT-initiation b therapeutic application of Ectoin Lozenges after SLIT-initiation or c control SLIT-initiation without application of Ectoin Lozenges
The symptoms itching swelling and irritation of mouth lips and throat will be documented by the patients once 30 minutes after SLIT-initiation
The current study aims to investigate the efficacy of Ectoin Lozenges EHT02 in patients suffering from oropharyngeal allergic symptoms The symptoms are induced by SLIT
Patients are dedicated to one of three groups a preventive application of Ectoin Lozenges before SLIT-initiation b therapeutic application of Ectoin Lozenges after SLIT-initiation or c control SLIT-initiation without application of Ectoin Lozenges
The symptoms itching swelling and irritation of mouth lips and throat will be documented by the patients once 30 minutes after SLIT-initiation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None