Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The results of this study will help in the development of a new type of nasal strip for management of nasal congestion and snoring.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Marketed nasal strip | Other | Marketed nasal strip |
|
| NexGen JB Organic PET/PE | Experimental | NexGen JB Organic PET/PE, prototype nasal dilator strip |
|
| NexGen AB 2R11 | Experimental | NexGen AB 2R11 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marketed nasal strip | Device | Marketed nasal strip |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in minimum cross sectional area (second restriction) of the nasal valve using acoustic rhinometry | baseline to within 2 hours post application | |
| Change from baseline in total nasal volume of the nose using acoustic rhinometry | baseline to within 2 hours post application |
| Measure | Description | Time Frame |
|---|---|---|
| Nasal airway breathing as measured by Posterior Rhinomanometry | Baseline to 2 hours | |
| Nasal airway breathing as measured by Peak Nasal Inspiratory Flow (PNIF) | Baseline to 2 hours | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Common Cold Centre | Cardiff | Wales | United Kingdom |
| 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| NexGen AB 2R11 |
| Device |
Nasal strip prototype |
|
| NexGen JB Organic PET/PE | Device | Nasal strip |
|
| Subjective perceptions of airway breathing |
| Baseline to 2 hours |