NCT01411969

Brief Summary

The aim of this study is to present new data for a better understanding of the anatomic correlation of these two notches. This study included 32 nasal cavities (16 individuals) with external nasal dilator strip (Breath Right®) and after decongestion (0.05% oxymetazoline chloride applied as an aerosol spray);

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2010

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 8, 2011

Completed
Last Updated

August 8, 2011

Status Verified

June 1, 2011

Enrollment Period

1 month

First QC Date

July 26, 2011

Last Update Submit

August 5, 2011

Conditions

Nasal Obstruction

Keywords

external nasal dilator stripnasal valveacoustic rhinometry

Study Arms (1)

External nasal dilator, decongestion

Drug: External Nasal Dilator Strip; 0.05% oxymetazoline chloride

Interventions

External Nasal Dilator Strip; 0.05% oxymetazoline chlorideDRUG

External Nasal Dilator Strip placed above the upper lateral cartilage; 20 minutes after decongestion with 0.05% oxymetazoline chloride applied as an aerosol spray (two times); after decongestion with ENDS.

Also known as: Breath Right®
External nasal dilator, decongestion

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

32 nasal cavities of 16 normal adult Caucasian individuals

You may qualify if:

  • Adult, Caucasian

You may not qualify if:

  • Allergies, sinusitis, nasal polyps, external nasal deformities congenital or acquired, obstructive nasal deviation and regular use of any drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, São Paulo, 3471, Brazil

Location

Related Publications (2)

  • Seren E. The effect of an adhesive external nasal dilator strip on the inspiratory nasal airflow. Am J Rhinol Allergy. 2010 Jan-Feb;24(1):e29-31. doi: 10.2500/ajra.2010.24.3426.

    PMID: 20109318RESULT

  • Nigro CE, Mion O, Mello JF Jr, Voegels RL, Roithmann R. Acoustic rhinometry: impact of external nasal dilator on the two first notches of the rhinogram. Am J Rhinol Allergy. 2011 Nov-Dec;25(6):e247-50. doi: 10.2500/ajra.2011.25.3708.

    PMID: 22185733DERIVED

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic Diseases

Study Officials

  • Joao F Mello-Jr, Ph.D

    University of Sao Paulo General Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 26, 2011

First Posted

August 8, 2011

Study Start

June 1, 2010

Primary Completion

July 1, 2010

Study Completion

December 1, 2010

Last Updated

August 8, 2011

Record last verified: 2011-06

Locations

BR(1)