Official Title
A Clinical Study to Evaluate the Effectiveness of Combined Use of Two Nasal Protective Medical Devices (Noseguard and Noseguard Night) for Reducing Respiratory Infection Rates and Assessing Usability
Brief Summary

This study is a prospective clinical study to evaluate the effectiveness of combined useof two nasal protective medical devices (Noseguard and Noseguard Night) in reducingrespiratory infection rates, including COVID-19 and influenza, in real-world conditions.The study will also assess usability, satisfaction, and safety using electronicpatient-reported outcomes (ePRO).

Detailed Description

This study is a prospective clinical study conducted in Korea to evaluate the
effectiveness of combined use of two nasal protective medical devices, Noseguard and
Noseguard Night, for preventing respiratory infections.

A total of approximately 2,000 adult participants will be enrolled and followed for 8
weeks. Participants will use Noseguard during daytime activities and Noseguard Night
before sleep.

Data will be collected using electronic patient-reported outcomes (ePRO) at baseline and
at Weeks 2, 4, 6, and 8. The primary endpoint is the incidence of respiratory infections,
including COVID-19 and influenza.

Secondary endpoints include symptom severity, duration of symptoms, usability,
satisfaction, and safety outcomes such as adverse events.

This study aims to generate real-world evidence on the effectiveness and usability of
nasal protective devices for respiratory infection prevention.

Not yet recruiting
Respiratory Infection Virus
COVID-19
Influenza

Device: Noseguard and Noseguard Night

Nasal spray medical devices used to form a protective barrier on the nasal mucosa to
reduce viral entry.

Eligibility Criteria

Inclusion Criteria:

- Adults aged ≥19 years

- Able to provide informed consent

Exclusion Criteria:

- Hypersensitivity to device components

- Current COVID-19 or influenza infection

- Severe nasal disease

- Pregnant or breastfeeding women

Eligibility Gender
All
Eligibility Age
Minimum: 19 Years ~ Maximum: N/A
Countries
South Korea
Locations

Jeonbuk University Hospital
Jeonju, South Korea

Investigator: SoHeui Kim
Contact: 82-10-2994-5887
2210325@daewoong.co.kr

Contacts

SoHeui Kim
82-10-2994-5887
2210325@daewoong.co.kr

Not Provided

Daewoong Pharmaceutical Co. LTD.
NCT Number
Keywords
nasal spray
medical device
Infection prevention
ePRO
Real-World
MeSH Terms
COVID-19
Influenza, Human