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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Noseguard Combined Use | Experimental | Participants will use Noseguard during daytime activities and Noseguard Night before sleep for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noseguard and Noseguard Night | Device | Nasal spray medical devices used to form a protective barrier on the nasal mucosa to reduce viral entry. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Respiratory Infection | Incidence of respiratory infections, including COVID-19 and influenza, during the 8-week study period. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Respiratory Infection by Interval | Incidence of respiratory infection during each interval | Up to Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SoHeui Kim | Contact | 82-10-2994-5887 | 2210325@daewoong.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeonbuk University Hospital | Jeonju | South Korea |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |