Healthy Volunteer
Conditions
Keywords
nasal patency, acoustic rhinometry, nasal strip
Brief summary
The results of this study will help in the development of a new type of nasal strip for management of nasal congestion and snoring.
Interventions
DEVICEMarketed nasal strip
Marketed nasal strip
DEVICENexGen AB 2R11
Nasal strip prototype
DEVICENexGen JB Organic PET/PE
Nasal strip
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history
Exclusion criteria
* Currently experiencing cold or flu * History of perennial or allergic rhinitis or rhinitis medicamentosa * Evidence of nasal polyps as documented by anterior rhinoscopy * Evidence of significant nasal tract structural malformations including a severe deviated septum (where subjects are indicated for surgery) or a concha bullosa as documented by anterior rhinoscopy * Visible open sores, sunburn, irritation, eczema or chronic skin condition on the face to nose * Bacterial sinusitis infection during 2 weeks prior to entry in the baseline phase of the study * Any other condition that in the opinion of the investigator would have an affect on nasal breathing * Use of any product containing menthol within two hours prior to any subjective measures involved in the study * Had an allergic contact dermatitis on the face within 30 days prior to entry * History of chronic or active skin or other immunologic (rheumatoid, psoriasis) disease * History of skin cancer * Use of antibiotics or alpha adrenergic drugs (all forms) within 1 week prior to entry in the baseine phase of the study * Use of glucocorticosteroids (all forms) within 1 month prior to entry in the baseline phase of the study * Any current treatment which in the opinion of the investigator will affect nasal congestion
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| Subjective perceptions of airway breathing | Baseline to 2 hours |
Countries
United Kingdom
Outcome results
None listed