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NCT01621685 · ClinicalTrials.gov registry record · Phase 1
Human Safety of Capsaicin Inhalation Challenge Testing for Young and Older Men
A Phase 1 study, sponsored by University of South Florida.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT01621685: Completed Phase 1 study, sponsored by University of South Florida.
NCT01621685 is a Phase 1 study that has completed, run by University of South Florida. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01621685, a Phase 1 study, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
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.
Primary Outcome
Single breaths of capsaicin were delivered in ascending order, with normal saline solution randomly interspersed to increase challenge blindness, until two (C2) and five (C5) or more coughs were reached. The different concentrations were delivered at 2 minute intervals. After each inhalation dose the following were performed: FEV1 measurement, administer of the symptom questionnaire and auscultation of the chest for wheezing.
Interventions
- BIOLOGICAL biological/vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2004-09 |
| Est. Completion | 2007-09 |
| Phase | Phase 1 |
What the finished NCT01621685 record still lists
NCT01621685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 1 intervention - of which biological/vaccine is the first listed.
NCT01621685 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01621685 about?
NCT01621685 is a clinical study titled "Human Safety of Capsaicin Inhalation Challenge Testing for Young and Older Men". 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 Cap...
What is the current status of trial NCT01621685?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2004-09. Estimated completion is 2007-09.
What interventions are being tested in trial NCT01621685?
The interventions under investigation include: biological/vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01621685?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01621685's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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