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Not Yet RecruitingNCT07516977

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
Phase
N/A
Study type
Interventional
Enrollment
2,000 (estimated)
Sponsor
Daewoong Pharmaceutical Co. LTD. · Industry
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICENoseguard and Noseguard NightNasal spray medical devices used to form a protective barrier on the nasal mucosa to reduce viral entry.

Timeline

Start date
2026-04-20
Primary completion
2026-08-31
Completion
2026-12-31
First posted
2026-04-08
Last updated
2026-04-08

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT07516977. Inclusion in this directory is not an endorsement.