An Evaluation of Two Novel Nasal Strip Prototypes on Nasal Patency

Phase 1

Completed

• Conditions: Healthy Volunteer

• Registration Number: NCT01105949
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Study First Submitted: 2010-04-15
• Study First Submitted QC: 2010-04-15
• Study First Posted: 2010-04-19
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-25
• Last Update Posted: 2012-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Common Cold Centre; 🇬🇧 Cardiff, Wales, United Kingdom