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

NCT ID: NCT01495494

Last Updated: 2014-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2009-11-30

Brief Summary

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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

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Marketed nasal strip

Marketed nasal strip

Group Type ACTIVE_COMPARATOR

Marketed Nasal Strip

Intervention Type DEVICE

Breathe Right Nasal Strips - Clear small/medium strip

Prototype nasal dilator

Prototype nasal dilator

Group Type EXPERIMENTAL

Prototype Nasal Dilator

Intervention Type DEVICE

Prototype Nasal Dilator AB2R11

Interventions

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Marketed Nasal Strip

Breathe Right Nasal Strips - Clear small/medium strip

Intervention Type DEVICE

Prototype Nasal Dilator

Prototype Nasal Dilator AB2R11

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Essex Testing Clinic, Inc

Verona, New Jersey, United States

Site Status

Countries

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United States

References

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Ward J, Ciesla R, Becker W, Shanga GM. Randomized Trials of Nasal Patency and Dermal Tolerability With External Nasal Dilators in Healthy Volunteers. Allergy Rhinol (Providence). 2018 Oct 5;9:2152656718796740. doi: 10.1177/2152656718796740. eCollection 2018 Jan-Dec.

Reference Type DERIVED
PMID: 30305980 (View on PubMed)

Other Identifiers

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B3560692

Identifier Type: -

Identifier Source: org_study_id