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

April 15, 2010
January 25, 2012
September 2009
October 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01105949 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
An Evaluation of Two Novel Nasal Strip Prototypes on Nasal Patency
An Evaluation of Two Novel Breathe Right Nasal Strip Prototypes on Nasal Patency

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Volunteer
  • Device: Marketed nasal strip
    Marketed nasal strip
  • Device: NexGen AB 2R11
    Nasal strip prototype
  • Device: NexGen JB Organic PET/PE
    Nasal strip
  • Marketed nasal strip
    Marketed nasal strip
    Intervention: Device: Marketed nasal strip
  • Experimental: NexGen JB Organic PET/PE
    NexGen JB Organic PET/PE, prototype nasal dilator strip
    Intervention: Device: NexGen JB Organic PET/PE
  • Experimental: NexGen AB 2R11
    NexGen AB 2R11
    Intervention: Device: NexGen AB 2R11
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
October 2009
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01105949
B3560645
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP