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OpenTrials
Completed

NCT Number: NCT01495494

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

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

Completed

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Key information

Conditions

Healthy Subjects

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Essex Testing Clinic, Inc

Verona, New Jersey, 07044, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy subjects

Treatment and study plan

Marketed nasal strip

Device

Breathe Right Nasal Strips - Clear small/medium strip

Prototype Nasal Dilator

Device

Prototype Nasal Dilator AB2R11

Primary outcomes

  1. Dermal response score of the application site of the nasal strip

    Time frame: Baseline through 7 days

Secondary outcomes

  1. Subjective questionnaire regarding comfort, overnight adherence, and ease of removal of the strip

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 20, 2011
Registry last updated
Nov 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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