Standardizing selection criteria in nasal medication studies.
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.


OBJECTIVE
to standardize the evaluation of candidates for control groups in clinical studies on nasal topical medications.


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.


METHODS
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.


CONCLUSIONS
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.
Borin
Andrei
A
Department of Clinical Research, Libbs Pharmaceutical Ltda., Sao Paulo, SP, Brazil.
Abib
Eduardo
E
Araujo
Cleomines Izidio
CI
Martinez
Luis Lopez
LL
Rodrigues
Heloisio
H
D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D016022:Case-Control Studies; D003430:Cross-Sectional Studies; D006801:Humans; D006969:Hypersensitivity, Immediate / Q000175:diagnosis; D008297:Male; D008875:Middle Aged; D009079:Mucociliary Clearance; D018579:Patient Selection; D012439:Saccharin; D012882:Skin Tests; D055815:Young Adult
D012439:Saccharin