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NCT01495494 Clinical Trial

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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01495494
Other study ID # B3560692
Secondary ID
Status Completed
Phase Phase 1
First received December 16, 2011
Last updated November 20, 2014
Start date November 2009
Est. completion date November 2009

Study information
Verified date June 2014
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date November 2009
Est. primary completion date November 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Healthy subjects

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Marketed Nasal Strip
Breathe Right Nasal Strips - Clear small/medium strip
• Prototype Nasal Dilator
Prototype Nasal Dilator AB2R11

Locations
Country Name City State
United States Essex Testing Clinic, Inc Verona New Jersey

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dermal response score of the application site of the nasal strip Baseline through 7 days Yes
Secondary Subjective questionnaire regarding comfort, overnight adherence, and ease of removal of the strip 7 days No
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