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NCT Number: NCT07516977

Noseguard for Prevention of Respiratory Infections in Real-World Use

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).

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Noseguard and Noseguard Night

Device

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

Primary outcomes

  1. Incidence of Respiratory Infection

    Time frame: Week 8

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

Secondary outcomes

  1. Incidence of Respiratory Infection by Interval

    Time frame: Up to Week 8

    Incidence of respiratory infection during each interval

Study contacts

Contact information is provided by the study sponsor or research team.

SoHeui Kim

CONTACT

[email protected]

82-10-2994-5887

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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