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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01495494
First received: December 16, 2011
Last updated: February 27, 2014
Last verified: February 2014
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Subjective questionnaire regarding comfort, overnight adherence, and ease of removal of the strip [ Time Frame: 7 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01495494     History of Changes
Other Study ID Numbers: B3560692
Study First Received: December 16, 2011
Last Updated: February 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by GlaxoSmithKline:
Nasal Strip

ClinicalTrials.gov processed this record on April 22, 2014