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Related Experiment Video

Updated: Jun 15, 2026

Nasal Potential Difference to Quantify Trans-epithelial Ion Transport in Mice
08:55

Nasal Potential Difference to Quantify Trans-epithelial Ion Transport in Mice

Published on: July 4, 2018

Standardizing selection criteria in nasal medication studies.

Andrei Borin1, Eduardo Abib, Cleomines Izidio Araujo

  • 1Department of Clinical Research, Libbs Pharmaceutical Ltda., Sao Paulo, SP, Brazil.

Brazilian Journal of Otorhinolaryngology
|March 9, 2010
PubMed
Summary

Standardizing nasosinusal normality is crucial for clinical trials of nasal topical medications. A sequential evaluation protocol effectively identified suitable candidates for control groups, ensuring study validity.

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Standardized Measurement of Nasal Membrane Transepithelial Potential Difference (NPD)
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Published on: September 13, 2018

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Standardized Measurement of Nasal Membrane Transepithelial Potential Difference (NPD)
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Standardized Measurement of Nasal Membrane Transepithelial Potential Difference (NPD)

Published on: September 13, 2018

Area of Science:

  • Otorhinolaryngology
  • Clinical Pharmacology
  • Medical Research Methodology

Background:

  • Clinical studies investigating nasal topical medications necessitate standardized control groups.
  • Defining 'nasosinusal normality' is essential for accurate upper airway evaluations.

Purpose of the Study:

  • To standardize the evaluation process for identifying suitable control group candidates in nasal topical medication studies.
  • Establish a reliable method for assessing nasosinusal normality.

Main Methods:

  • A sequential and exclusionary assessment protocol was applied to healthy male volunteers (18-50 years).
  • Methods included clinical evaluation, skin hypersensitivity testing, saccharin test for mucociliary clearance, flexible nasofibroscopy, and nasal cytology.
  • A cross-sectional contemporary cohort study design was employed.

Main Results:

  • Out of 33 initial participants, 14 were excluded clinically, and 2 were excluded due to atopy detected by skin testing.
  • Mucociliary clearance was normal in 17 participants; nasal endoscopy excluded 2 more individuals.
  • Nasal cytology confirmed normality in the final 15 participants, representing 45.5% of the initial cohort.

Conclusions:

  • The developed protocol for sequential and exclusionary evaluation effectively identified candidates for control groups.
  • This standardization is vital for the integrity of clinical studies involving nasal topical medications.