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NAC Trial for Anosmia

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02481609
Enrollment
29
Registered
2015-06-25
Start date
2014-07-31
Completion date
2017-12-01
Last updated
2018-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anosmia

Keywords

Loss of Smell, Olfaction, Hyposmia

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.

Interventions

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* adults at least 18 years of age with documented microsmia or anosmia by University of Pennsylvania Smell Identification Test. * patients must have no evidence of active sinonasal disease by nasal endoscopy or CT or MRI * negative CT or MRI

Exclusion criteria

* adults unable to consent * individuals who are not yet adults (infants, children, teenagers) * pregnant women, prisoners, employees or subordinates, * patients with known sensitivity to NAC or severe asthma * patients with sinus or central disease on CT or MRI imaging.

Design outcomes

Primary

MeasureTime frameDescription
Change in the Smell Identification Test scoreBaseline and three months after completion of treatmentSense of smell is measured using the Smell Identification Test (a standardized 40-item forced choice self administered microencapsulated odor scratch-and-sniff style test )

Secondary

MeasureTime frameDescription
Change in Sino-Nasal Outcome Test (SNOT-20) scoreBaseline and three months after completion of treatmentValidated quality of life assessment tool for nasal and sinus disease patients

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026