An Evaluation of Two Novel Nasal Strip Prototypes on Nasal Patency

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01105949
First received: April 15, 2010
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

The results of this study will help in the development of a new type of nasal strip for management of nasal congestion and snoring.


Condition Intervention Phase
Healthy Volunteer
Device: Marketed nasal strip
Device: NexGen AB 2R11
Device: NexGen JB Organic PET/PE
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Evaluation of Two Novel Breathe Right Nasal Strip Prototypes on Nasal Patency

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in total nasal volume of the nose using acoustic rhinometry [ Time Frame: baseline to within 2 hours post application ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nasal airway breathing as measured by Posterior Rhinomanometry [ Time Frame: Baseline to 2 hours ] [ Designated as safety issue: No ]
  • Nasal airway breathing as measured by Peak Nasal Inspiratory Flow (PNIF) [ Time Frame: Baseline to 2 hours ] [ Designated as safety issue: No ]
  • Subjective perceptions of airway breathing [ Time Frame: Baseline to 2 hours ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: September 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Marketed nasal strip
Marketed nasal strip
Device: Marketed nasal strip
Marketed nasal strip
Experimental: NexGen JB Organic PET/PE
NexGen JB Organic PET/PE, prototype nasal dilator strip
Device: NexGen JB Organic PET/PE
Nasal strip
Experimental: NexGen AB 2R11
NexGen AB 2R11
Device: NexGen AB 2R11
Nasal strip prototype

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01105949

Locations
United Kingdom
Common Cold Centre
Cardiff, Wales, United Kingdom, Not Available
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01105949     History of Changes
Other Study ID Numbers: B3560645
Study First Received: April 15, 2010
Last Updated: January 25, 2012
Health Authority: United Kingdom: Ethics Committee

Keywords provided by GlaxoSmithKline:
nasal patency
acoustic rhinometry
nasal strip

ClinicalTrials.gov processed this record on April 16, 2014