Clinical Trial: NAC Trial for Anosmia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Pilot Study of Topical Intranasal N-acetyl Cysteine Administration for the Treatment of Anosmia

Brief Summary: The purpose of this research study is to evaluate the use of NAC in the treatment of anosmia (a loss of the sense of smell). This drug is already approved by the Food and Drug Administration (FDA) for oral or pulmonary (lung) inhaled use for other medical conditions. However, there is research evidence that the medication may promote nerve recovery (help nerves work better after they are damaged). Since anosmia involves nerve problems, we believe the nasal spray may help treat anosmia. The medication has been in use for many years for other conditions, without safety problems.

Detailed Summary:
Sponsor: University of Miami

Current Primary Outcome: Change in the Smell Identification Test score [ Time Frame: Baseline and three months after completion of treatment ]

Sense of smell is measured using the Smell Identification Test (a standardized 40-item forced choice self administered microencapsulated odor "scratch-and-sniff" style test )


Original Primary Outcome: Same as current

Current Secondary Outcome: Change in Sino-Nasal Outcome Test (SNOT-20) score [ Time Frame: Baseline and three months after completion of treatment ]

Validated quality of life assessment tool for nasal and sinus disease patients


Original Secondary Outcome: Same as current

Information By: University of Miami

Dates:
Date Received: June 22, 2015
Date Started: July 2014
Date Completion: December 31, 2017
Last Updated: February 15, 2017
Last Verified: February 2017