NAC Trial for Anosmia

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

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.

Study Overview

• Status: Completed
• Conditions: Anosmia
• Intervention / Treatment: Drug: N-acetyl cysteine (NAC)

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami, Miller School of Medicine, Clinical Research Building

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NAC arm; Topical intranasal N-acetyl cysteine (NAC 200 mg/2 ml vials) BID for one month	Drug: N-acetyl cysteine (NAC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Bradley J Goldstein, MD, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: June 22, 2015
• First Submitted That Met QC Criteria: June 22, 2015
• First Posted (Estimate): June 25, 2015

Study Record Updates

• Last Update Posted (Actual): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 16, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Loss of Smell; Olfaction; Hyposmia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Sensation Disorders; Olfaction Disorders; Anosmia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Protective Agents; Respiratory System Agents; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine
• Other Study ID Numbers: 20130996