An Evaluation of Two Novel Nasal Strip Prototypes on Nasal Patency

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Device: Marketed nasal strip; Device: NexGen JB Organic PET/PE; Device: NexGen AB 2R11

• 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

Arm && Interventions

Group	Intervention	Description
Marketed nasal strip	Marketed nasal strip	Marketed nasal strip
NexGen JB Organic PET/PE	NexGen JB Organic PET/PE	NexGen JB Organic PET/PE, prototype nasal dilator strip
NexGen AB 2R11	NexGen AB 2R11	NexGen AB 2R11

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