An Evaluation of Two Novel Nasal Strip Prototypes on Nasal Patency

Study Overview
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Brief Summary
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The results of this study will help in the development of a new type of nasal strip for management of nasal congestion and snoring.

Official Title
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An Evaluation of Two Novel Breathe Right Nasal Strip Prototypes on Nasal Patency

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Device: Marketed nasal strip
* Device: NexGen AB 2R11
* Device: NexGen JB Organic PET/PE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Marketed nasal strip<br>Marketed nasal strip | Device: Marketed nasal strip<br>* Marketed nasal strip<br>|
| Experimental: NexGen JB Organic PET/PE<br>NexGen JB Organic PET/PE, prototype nasal dilator strip | Device: NexGen JB Organic PET/PE<br>* Nasal strip<br>|
| Experimental: NexGen AB 2R11<br>NexGen AB 2R11 | Device: NexGen AB 2R11<br>* Nasal strip prototype<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Subjective perceptions of airway breathing |  | Baseline to 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasal patency, acoustic rhinometry, nasal strip