Usability and Tolerability Study in Human Subjects with a Novel Precision Olfactory Delivery (POD) Device

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November 15, 2013

Purpose

Summary

To compare the usability and tolerability of the Impel Precision Olfactory Delivery (POD) device to a reference conventional pump nasal spray device (CNS) in the administration of a saline dose.

Background and Objectives

The specific objectives of this study were to identify:
• How well participants tolerated nasal saline administered by each of the devices;
• Whether participants could readily use each of the devices; and
• Whether participants encountered any problems or errors of use that would indicate a potential need for change in device design, device-use instructions, and/or labeling of the Sponsor’s device.

Conclusions

  • The Impel POD outperformed the reference device in overall preference, saline deposition, accurate positioning for administration, impact on nasal conditions and priming before use.
  • The POD matched the reference device for tolerance to saline, and administration of saline.