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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014