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
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 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 September 18, 2014