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

Phase 1

Completed

• Conditions: Healthy Subjects

• 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

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