Skip to main content
OpenTrials
Completed

NCT Number: NCT01105949

An Evaluation of Two Novel 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Common Cold Centre

Cardiff, Wales, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Marketed nasal strip

Device

Marketed nasal strip

NexGen AB 2R11

Device

Nasal strip prototype

NexGen JB Organic PET/PE

Device

Nasal strip

Primary outcomes

  1. 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

  2. Change from baseline in total nasal volume of the nose using acoustic rhinometry

    Time frame: baseline to within 2 hours post application

Secondary outcomes

  1. Nasal airway breathing as measured by Posterior Rhinomanometry

    Time frame: Baseline to 2 hours

  2. Nasal airway breathing as measured by Peak Nasal Inspiratory Flow (PNIF)

    Time frame: Baseline to 2 hours

  3. Subjective perceptions of airway breathing

    Time frame: Baseline to 2 hours

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 19, 2010
Registry last updated
Jan 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.