An Evaluation of Two Novel Nasal Strip Prototypes on Nasal Patency

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01105949
• Other study ID #: B3560645
• Status: Completed
• Phase: Phase 1
• First received: April 15, 2010
• Last updated: January 25, 2012
• Start date: September 2009
• Est. completion date: October 2009

Study information

• Verified date: January 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Device:
• Marketed nasal strip
Marketed nasal strip
• NexGen AB 2R11
Nasal strip prototype
• NexGen JB Organic PET/PE
Nasal strip

Locations

Country	Name	City	State
United Kingdom	Common Cold Centre	Cardiff	Wales

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in minimum cross sectional area (second restriction) of the nasal valve using acoustic rhinometry		baseline to within 2 hours post application	No
Primary	Change from baseline in total nasal volume of the nose using acoustic rhinometry		baseline to within 2 hours post application	No
Secondary	Nasal airway breathing as measured by Posterior Rhinomanometry		Baseline to 2 hours	No
Secondary	Nasal airway breathing as measured by Peak Nasal Inspiratory Flow (PNIF)		Baseline to 2 hours	No
Secondary	Subjective perceptions of airway breathing		Baseline to 2 hours	No