An Evaluation of Two Novel Nasal Strip Prototypes on Nasal Patency

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2009-10-31

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.

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Marketed nasal strip

Group Type OTHER

Marketed nasal strip

Intervention Type DEVICE

Marketed nasal strip

NexGen JB Organic PET/PE

NexGen JB Organic PET/PE, prototype nasal dilator strip

Group Type EXPERIMENTAL

NexGen JB Organic PET/PE

Intervention Type DEVICE

Nasal strip

NexGen AB 2R11

Group Type EXPERIMENTAL

NexGen AB 2R11

Intervention Type DEVICE

Nasal strip prototype

Interventions

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Marketed nasal strip

Intervention Type DEVICE

NexGen AB 2R11

Nasal strip prototype

Intervention Type DEVICE

NexGen JB Organic PET/PE

Nasal strip

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes