Abstract
SummaryClinical 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.Aimto standardize the evaluation of candidates for control groups in clinical studies on nasal topical medications.Materials and Methodshealthy 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 designCross-sectional contemporary cohort.ResultsOf 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.ConclusionThe 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.
Highlights
Estudos clínicos sobre medicações tópicas nasais exigem a padronização de “normalidade nasossinusal” na constituição de grupos controle através de uma avaliação específica da via aérea superior
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
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
Summary
Andrei Borin 1, Eduardo Abib Junior 2, Cleomines Izidio Araujo 3, Luis Lopez Martinez 4, Heloisio Rodrigues 5. Conclusão: O protocolo proposto de avaliação sequencial e excludente foi efetivo na definição de candidatos à constituição de grupos controle em estudos clínicos sobre medicações tópicas nasais. Com o objetivo de estabelecermos um protocolo de testes e exames que permitam padronizar e comprovar um estado saudável e de “normalidade” do ponto de vista nasossinusal e para definir critérios de seleção e exclusão de sujeitos de pesquisa em estudos clínicos com medicações tópicas nasais, realizamos um levantamento das condições nasossinusais de uma população declarada saudável e assintomática recrutada em um centro de pesquisa na cidade de Campinas - SP. Elaboramos um protocolo que engloba uma avaliação clínica criteriosa e a realização sequencial e excludente do teste cutâneo de hipersensibilidade imediata, teste da sacarina, nasofibroscopia flexível e citograma nasal.
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