An Early Phase 1 interventional study of N-acetyl cysteine (NAC) in Anosmia, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-20.
Sponsored by University of Miami · Early Phase 1, Interventional, and Treatment
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.
117 studies on the registry are indexed under Anosmia; 39 are open to participants now.
This study's enrollment of 29 is below the median of 68 across 81 interventional studies indexed under Anosmia.
Browse Anosmia studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Topical intranasal N-acetyl cysteine (NAC 200 mg/2 ml vials) BID for one month
Drug: N-acetyl cysteine (NAC)
Change in the Smell Identification Test score
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 )
Time frame: Baseline and three months after completion of treatment
Change in Sino-Nasal Outcome Test (SNOT-20) score
Validated quality of life assessment tool for nasal and sinus disease patients
Time frame: Baseline and three months after completion of treatment
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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University of Miami