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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Device: Prototype Nasal Dilator; Device: Marketed Nasal Strip

• Registration Number: NCT01495494
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study evaluated the safety \& tolerability of two Breathe Right nasal strip prototypes. Prototypes were produced as an improvement to the currently marketed product.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Study First Submitted: 2011-12-16
• Study First Submitted QC: 2011-12-16
• Study First Posted: 2011-12-20
• Status Verified: 2014-06
• Last Update Submitted: 2014-11-20
• Last Update Posted: 2014-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Healthy subjects

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prototype nasal dilator	Prototype Nasal Dilator	Prototype nasal dilator
Marketed nasal strip	Marketed Nasal Strip	Marketed nasal strip

Primary Outcome Measures

Name	Time	Method
Dermal response score of the application site of the nasal strip	Baseline through 7 days

Secondary Outcome Measures

Name	Time	Method
Subjective questionnaire regarding comfort, overnight adherence, and ease of removal of the strip	7 days

Trial Locations

Locations (1)

Essex Testing Clinic, Inc; 🇺🇸 Verona, New Jersey, United States