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

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: December 16, 2011
Last updated: November 20, 2014
Last verified: June 2014
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 Blind (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


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

Inclusion Criteria:

  • Healthy subjects
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01495494

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

Responsible Party: GlaxoSmithKline Identifier: NCT01495494     History of Changes
Other Study ID Numbers: B3560692
Study First Received: December 16, 2011
Last Updated: November 20, 2014

Keywords provided by GlaxoSmithKline:
Nasal Strip processed this record on May 25, 2017