| Standardizing selection criteria in nasal medication studies. | |
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MedLine Citation:
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PMID: 20209290 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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Andrei Borin; Eduardo Abib; Cleomines Izidio Araujo; Luis Lopez Martinez; Heloisio Rodrigues |
Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: Brazilian journal of otorhinolaryngology Volume: 75 ISSN: 1808-8686 ISO Abbreviation: Braz J Otorhinolaryngol Publication Date: 2009 Nov-Dec |
Date Detail:
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Created Date: 2010-03-08 Completed Date: 2010-06-22 Revised Date: 2011-10-04 |
Medline Journal Info:
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Nlm Unique ID: 101207337 Medline TA: Braz J Otorhinolaryngol Country: Brazil |
Other Details:
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Languages: eng Pagination: 872-8 Citation Subset: IM |
Affiliation:
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Department of Clinical Research, Libbs Pharmaceutical Ltda., Sao Paulo, SP, Brazil. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Intranasal* Adolescent Adult Case-Control Studies Cross-Sectional Studies Humans Hypersensitivity, Immediate / diagnosis Male Middle Aged Mucociliary Clearance* Patient Selection* Saccharin / diagnostic use Skin Tests Young Adult |
| Chemical | |
Reg. No./Substance:
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81-07-2/Saccharin |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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