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Human Safety of Capsaicin Inhalation Challenge Testing for Young and Older Men

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Contents

clinicaltrials.gov/study/NCT01621685
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT016216850
Trial Recruitment Size
400
Trial Sponsor
University of South Florida
University of South Florida
0
Trial Collaborator
Centers for Disease Control and Prevention
Centers for Disease Control and Prevention
0
Clinical Trial Start Date
2004
0
Primary Completion Date
2007
0
Study Completion Date
2007
0
Clinical Trial Study Type
Interventional0
Intervention Type
Biological0
Interventional Trial Phase
Phase 10
Official Name
The Role of Age on the Human Cough Reflex0
Last Updated
June 18, 2012
0
Allocation Type
NA0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0

Other attributes

Intervention Treatment
biological/vaccine0
Study summary

In 2004, the investigators initiated a human Capsaicin inhalation experiment under an Investigational New Drug (IND) protocol approved by the FDA (IND 69,642) and the subject safety procedures instituted and approved by the Institutional Review Board (IRB). As part of the study protocol, inhaled Capsaicin solutions were analyzed using high performance liquid chromatography (HPLC). The investigation employed safety procedures while conducting the human inhalation investigations. In addition, during our investigations we observed discrepancies between the predicted Capsaicin concentrations mixed by a registered pharmacist and the actual capsaicin concentrations determined by HPLC. The stability of Capsaicin solutions stored over a seven month period and refrigerated at 4degrees C and protected against ultraviolet light were examined.

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