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