NCT01495494

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2011

Completed
Last Updated

November 24, 2014

Status Verified

June 1, 2014

Enrollment Period

Same day

First QC Date

December 16, 2011

Last Update Submit

November 20, 2014

Conditions

Healthy Subjects

Keywords

Nasal Strip

Outcome Measures

Primary Outcomes (1)

  • Dermal response score of the application site of the nasal strip

    Baseline through 7 days

Secondary Outcomes (1)

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

    7 days

Study Arms (2)

Marketed nasal strip

ACTIVE COMPARATOR

Marketed nasal strip

Device: Marketed Nasal Strip

Prototype nasal dilator

EXPERIMENTAL

Prototype nasal dilator

Device: Prototype Nasal Dilator

Interventions

Marketed Nasal StripDEVICE

Breathe Right Nasal Strips - Clear small/medium strip

Marketed nasal strip
Prototype Nasal DilatorDEVICE

Prototype Nasal Dilator AB2R11

Prototype nasal dilator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Essex Testing Clinic, Inc

Verona, New Jersey, 07044, United States

Location

Related Publications (1)

  • 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.

    PMID: 30305980DERIVED

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2011

First Posted

December 20, 2011

Study Start

November 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

November 24, 2014

Record last verified: 2014-06

Locations

US(1)