An Evaluation of Two Novel Nasal Strip Prototypes on Nasal Patency

January 25, 2012 updated by: GlaxoSmithKline

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Wales
      • Cardiff, Wales, United Kingdom
        • Common Cold Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Device: NexGen AB 2R11
Nasal strip prototype

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
baseline to within 2 hours post application
Change from baseline in total nasal volume of the nose using acoustic rhinometry
Time Frame: baseline to within 2 hours post application
baseline to within 2 hours post application

Secondary Outcome Measures

Outcome Measure
Time Frame
Nasal airway breathing as measured by Posterior Rhinomanometry
Time Frame: Baseline to 2 hours
Baseline to 2 hours
Nasal airway breathing as measured by Peak Nasal Inspiratory Flow (PNIF)
Time Frame: Baseline to 2 hours
Baseline to 2 hours
Subjective perceptions of airway breathing
Time Frame: Baseline to 2 hours
Baseline to 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

April 15, 2010

First Submitted That Met QC Criteria

April 15, 2010

First Posted (Estimate)

April 19, 2010

Study Record Updates

Last Update Posted (Estimate)

January 30, 2012

Last Update Submitted That Met QC Criteria

January 25, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B3560645

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Volunteer

Clinical Trials on Marketed nasal strip

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe