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This study evaluated the safety & tolerability of two Breathe Right nasal strip prototypes. Prototypes were produced as an improvement to the currently marketed product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Marketed nasal strip | Active Comparator | Marketed nasal strip |
|
| Prototype nasal dilator | Experimental | Prototype nasal dilator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marketed Nasal Strip | Device | Breathe Right Nasal Strips - Clear small/medium strip |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dermal response score of the application site of the nasal strip | Baseline through 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective questionnaire regarding comfort, overnight adherence, and ease of removal of the strip | 7 days |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Essex Testing Clinic, Inc | Verona | New Jersey | 07044 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30305980 | Derived | Ward J, Ciesla R, Becker W, Shanga GM. Randomized Trials of Nasal Patency and Dermal Tolerability With External Nasal Dilators in Healthy Volunteers. Allergy Rhinol (Providence). 2018 Oct 5;9:2152656718796740. doi: 10.1177/2152656718796740. eCollection 2018 Jan-Dec. |
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| Prototype Nasal Dilator | Device | Prototype Nasal Dilator AB2R11 |
|