NCT01105949CompletedPhase 1
An Evaluation of Two Novel Breathe Right Nasal Strip Prototypes on Nasal Patency
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Change from baseline in minimum cross sectional area (second restriction) of the nasal valve using acoustic rhinometry
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Change from baseline in minimum cross sectional area (second restriction) of the nasal valve using acoustic rhinometry
Time Frame: baseline to within 2 hours post application
Change from baseline in total nasal volume of the nose using acoustic rhinometry
Time Frame: baseline to within 2 hours post application
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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