NAC Trial for Anosmia

NCT02481609 | Completed Early Phase 1

• 1 other identifier: 20130996
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Anosmia

Keywords

Loss of Smell; Olfaction; Hyposmia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Sino-Nasal Outcome Test (SNOT-20) score

  Baseline and three months after completion of treatment

Study Arms (1)

NAC arm

EXPERIMENTAL

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

Drug: N-acetyl cysteine (NAC)

Interventions

N-acetyl cysteine (NAC) DRUG

NAC arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami, Miller School of Medicine, Clinical Research Building

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Anosmia

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Bradley J Goldstein, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: June 25, 2015
• Study Start: July 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 20, 2018

Record last verified: 2018-03

Locations

US (1)