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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01495494
First Posted: December 20, 2011
Last Update Posted: November 24, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
This study evaluated the safety & tolerability of two Breathe Right nasal strip prototypes. Prototypes were produced as an improvement to the currently marketed product.

Condition Intervention Phase
Healthy Subjects Device: Marketed Nasal Strip Device: Prototype Nasal Dilator Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Multiple Use Tolerability Study of a Breathe Right Nasal Strip Prototype

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Dermal response score of the application site of the nasal strip [ Time Frame: Baseline through 7 days ]

Secondary Outcome Measures:
  • Subjective questionnaire regarding comfort, overnight adherence, and ease of removal of the strip [ Time Frame: 7 days ]

Enrollment: 80
Study Start Date: November 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Marketed nasal strip
Marketed nasal strip
Device: Marketed Nasal Strip
Breathe Right Nasal Strips - Clear small/medium strip
Experimental: Prototype nasal dilator
Prototype nasal dilator
Device: Prototype Nasal Dilator
Prototype Nasal Dilator AB2R11

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01495494


Locations
United States, New Jersey
Essex Testing Clinic, Inc
Verona, New Jersey, United States, 07044
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01495494     History of Changes
Other Study ID Numbers: B3560692
First Submitted: December 16, 2011
First Posted: December 20, 2011
Last Update Posted: November 24, 2014
Last Verified: June 2014

Keywords provided by GlaxoSmithKline:
Nasal Strip