NAC Trial for Anosmia

Anosmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02481609
• Other study ID #: 20130996
• Status: Completed
• Phase: Early Phase 1
• First received: June 22, 2015
• Last updated: March 16, 2018
• Start date: July 2014
• Est. completion date: December 1, 2017

Study information

• Verified date: March 2018
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anosmia
• Olfaction Disorders

Intervention

Drug:
• N-acetyl cysteine (NAC)

Locations

Country	Name	City	State
United States	University of Miami, Miller School of Medicine, Clinical Research Building	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 )	Baseline and three months after completion of treatment
Secondary	Change in Sino-Nasal Outcome Test (SNOT-20) score	Validated quality of life assessment tool for nasal and sinus disease patients	Baseline and three months after completion of treatment