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Noseguard for Prevention of Respiratory Infections in Real-World Use

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07516977
Enrollment
2000
Registered
2026-04-08
Start date
2026-04-20
Completion date
2026-12-31
Last updated
2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Influenza, Respiratory Infection Virus

Keywords

Nasal Spray, Medical Device, Infection prevention, ePRO, Real-World

Brief summary

This study is a prospective clinical study to evaluate the effectiveness of combined use of two nasal protective medical devices (Noseguard and Noseguard Night) in reducing respiratory infection rates, including COVID-19 and influenza, in real-world conditions. The study will also assess usability, satisfaction, and safety using electronic patient-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.

Interventions

DEVICENoseguard and Noseguard Night

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

Sponsors

Daewoong Pharmaceutical Co. LTD.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Respiratory InfectionWeek 8Incidence of respiratory infections, including COVID-19 and influenza, during the 8-week study period.

Secondary

MeasureTime frameDescription
Incidence of Respiratory Infection by IntervalUp to Week 8Incidence of respiratory infection during each interval

Countries

South Korea

Contacts

CONTACTSoHeui Kim
2210325@daewoong.co.kr82-10-2994-5887

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026