Status:
COMPLETED
Safety and Efficacy of DSM 32444 Postbiotic in the Treatment of Acute Rhinosinusitis
Lead Sponsor:
Huro Biotech Joint Stock Company
Collaborating Sponsors:
Vietstar Biomedical Research
Conditions:
Rhinosinusitis
Rhinitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 nos...
Detailed Description
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 nos...
Eligibility Criteria
Inclusion
- Confirmed rhinosinusitis patients (according to Vietnam's MOH guidelines for diagnosis of rhinosinusitis), ≥18 years of age, at the time of signing the informed consent.
- Must be in generally good health, except rhinosinusitis
- Patients who are able to use an e-Diary or Paper Diary during the study to report their health status
- Patients capable of giving a signed informed consent form (ICF)
Exclusion
- Presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation (Grade 1b - 4)
- Other nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities.
- Nasal surgery or sinus surgery within the previous year
- Chronic sinusitis - more than 3 episodes per year
- Asthma (with the exception of mild, intermittent asthma). Subjects with mild, intermittent asthma who only require short-acting inhaled bronchodilators (not more often than twice per week) and who do not have nocturnal awakening as a result of asthma are eligible for enrolment.
- Planned travel outside of the study area during the study period.
- Use of any investigational drug within 30 days prior to Day screening. No investigational products are permitted for use during the conduct of this study.
- Existence of any medical condition, which in the opinion of the investigator, might significantly affect the subject's ability to complete this trial; or their safety in this trial.
Key Trial Info
Start Date :
December 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05999955
Start Date
December 29 2022
End Date
May 25 2023
Last Update
March 5 2024
Active Locations (1)
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1
Thai Binh University of Medicine and Pharmacy
Thái Bình, Thai Binh, Vietnam