Standardizing selection criteria in nasal medication studies.

Abstract:

UNLABELLED:Clinical studies on nasal topical medications require the standardization of 'nasosinusal normality' in order to establish control groups through a specific evaluation of the upper airways. AIM:to standardize the evaluation of candidates for control groups in clinical studies on nasal topical medications. MATERIAL AND METHODS:healthy male volunteers of 18 to 50 years of age, asymptomatic from the nasosinusal standpoint were subjected to a sequential and excluding assessment made up of clinical evaluation, immediate hypersensitivity skin test, saccharin test, flexible nasofibroscopy and nasal cytology. STUDY DESIGN:Cross-sectional contemporary cohort. RESULTS:Of the 33 people originally enrolled, 14 (42.4%) were excluded for clinical reasons. Of the 19 remaining, 2 (10.5%) had atopy diagnosed in the skin test and were excluded. 17 were tested with saccharin and presented normal mucociliary clearance. Evaluation by nasal endoscopy showed abnormality in 2 cases (11.8%) and these were excluded. The remaining 15 were submitted to nasal cytology, which proved normal, representing 45.5% of those initially included. CONCLUSION:The proposed protocol for sequential and excluding evaluation was effective in defining candidates for the establishment of control groups in clinical studies on nasal topical medications.

authors

Borin A,Abib E Jr,Araujo CI,Martinez LL,Rodrigues H

doi

10.1016/s1808-8694(15)30552-8

subject

Has Abstract

pub_date

2009-11-01 00:00:00

pages

872-8

issue

6

eissn

1808-8694

issn

1808-8686

pii

S1808-8694(15)30552-8

journal_volume

75

pub_type

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