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Impact of External Nasal Dilator on the Rhinogram (ARENDS)

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01411969
First received: July 26, 2011
Last updated: August 5, 2011
Last verified: June 2011
History of Changes
  Purpose

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);


Condition Intervention
Nasal Obstruction
 Drug: External Nasal Dilator Strip; 0.05% oxymetazoline chloride

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Acoustic Rhinometry: Impact of External Nasal Dilator on the Two First Notches of the Rhinogram

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo General Hospital:

Enrollment: 16
Study Start Date: June 2010
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
External nasal dilator, decongestion Drug: External Nasal Dilator Strip; 0.05% oxymetazoline chloride
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.
Other Name: Breath Right®

Detailed Description:

Acoustic rhinometry is more accurate in the anterior portion of the nasal cavities, from the nostril to the nasal valve (NV), the most important site of nasal obstruction. Literature presents different opinions regarding the anatomical correlation of the two notches at the beginning of the rhinogram curve in normal adult Caucasian individuals.

This prospective study included 32 nasal cavities under the following conditions: 1st - basal condition; 2nd - with external nasal dilator strip (ENDS) (Breath Right®); 3rd - after decongestion (0.05% oxymetazoline chloride applied as an aerosol spray); 4th - after decongestion with ENDS.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

32 nasal cavities of 16 normal adult Caucasian individuals

Criteria

Inclusion Criteria:

  • Adult, Caucasian

Exclusion Criteria:

  • Allergies, sinusitis, nasal polyps, external nasal deformities congenital or acquired, obstructive nasal deviation and regular use of any drug.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01411969

Locations
Brazil
University of Sao Paulo General Hospital
Sao Paulo, SP, Brazil, 3471
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Study Director: Joao F Mello-Jr, Ph.D University of Sao Paulo General Hospital
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Carlos Eduardo Nazareth Nigro, Ph.D, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01411969     History of Changes
Other Study ID Numbers: 306/03
Study First Received: July 26, 2011
Last Updated: August 5, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo General Hospital:
external nasal dilator strip
nasal valve
acoustic rhinometry

Additional relevant MeSH terms:
Nasal Obstruction
Nose Diseases
Respiratory Tract Diseases
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Otorhinolaryngologic Diseases
Oxymetazoline
Phenylephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Cardiotonic Agents
Mydriatics
Protective Agents

ClinicalTrials.gov processed this record on May 22, 2013