Noseguard for Prevention of Respiratory Infections in Real-World Use
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Noseguard and Noseguard Night.
- Who it may be relevant to
- Registry conditions: Respiratory Infection Virus, COVID-19, Influenza. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Device Noseguard and Noseguard Night
Nasal spray medical devices used to form a protective barrier on the nasal mucosa to reduce viral entry.
Primary outcome measures
- Incidence of Respiratory Infection [Time frame: Week 8]
Secondary outcome measures (1)
- Incidence of Respiratory Infection by Interval [Time frame: Up to Week 8]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
South Korea · 1 center
- Jeonbuk University Hospital — Jeonju
Identifiers
NCT: NCT07516977 · DW_NG_01