NAC Trial for Anosmia

Early Phase 1

Completed

• Conditions: Anosmia
• Interventions: Drug: N-acetyl cysteine (NAC)

• Registration Number: NCT02481609
• Lead Sponsor: University of Miami

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 Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-06-22
• Study First Submitted QC: 2015-06-22
• Study First Posted: 2015-06-25
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-16
• Last Update Posted: 2018-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NAC arm	N-acetyl cysteine (NAC)	Topical intranasal N-acetyl cysteine (NAC 200 mg/2 ml vials) BID for one month

Primary Outcome Measures

Name	Time	Method
Change in the Smell Identification Test score	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 )

Secondary Outcome Measures

Name	Time	Method
Change in Sino-Nasal Outcome Test (SNOT-20) score	Baseline and three months after completion of treatment	Validated quality of life assessment tool for nasal and sinus disease patients

Trial Locations

Locations (1)

University of Miami, Miller School of Medicine, Clinical Research Building; 🇺🇸 Miami, Florida, United States