A Multiple Use Tolerability Study of a Breathe Right Nasal Strip Prototype

November 20, 2014 updated by: GlaxoSmithKline
This study evaluated the safety & tolerability of two Breathe Right nasal strip prototypes. Prototypes were produced as an improvement to the currently marketed product.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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 States
    • New Jersey
      • Verona, New Jersey, United States, 07044
        • Essex Testing Clinic, Inc

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy subjects

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Marketed nasal strip
Device: Marketed Nasal Strip
Breathe Right Nasal Strips - Clear small/medium strip
Experimental: Prototype nasal dilator
Device: Prototype Nasal Dilator
Prototype Nasal Dilator AB2R11

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dermal response score of the application site of the nasal strip
Time Frame: Baseline through 7 days
Baseline through 7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjective questionnaire regarding comfort, overnight adherence, and ease of removal of the strip
Time Frame: 7 days
7 days

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

November 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

December 16, 2011

First Submitted That Met QC Criteria

December 16, 2011

First Posted (Estimate)

December 20, 2011

Study Record Updates

Last Update Posted (Estimate)

November 24, 2014

Last Update Submitted That Met QC Criteria

November 20, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B3560692

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.

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