Back to resultsNAC Trial for Anosmia
Primary Purpose
Anosmia
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
N-acetyl cysteine (NAC)
Sponsored by
About this trial
This is an interventional treatment trial for Anosmia focused on measuring Loss of Smell, Olfaction, Hyposmia
Eligibility Criteria
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.
Sites / Locations
- University of Miami, Miller School of Medicine, Clinical Research Building
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
NAC arm
Arm Description
Topical intranasal N-acetyl cysteine (NAC 200 mg/2 ml vials) BID for one month
Outcomes
Primary Outcome Measures
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 )
Secondary Outcome Measures
Change in Sino-Nasal Outcome Test (SNOT-20) score
Validated quality of life assessment tool for nasal and sinus disease patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02481609
Brief Title
NAC Trial for Anosmia
Official Title
Pilot Study of Topical Intranasal N-acetyl Cysteine Administration for the Treatment of Anosmia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anosmia
Keywords
Loss of Smell, Olfaction, Hyposmia
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NAC arm
Arm Type
Experimental
Arm Description
Topical intranasal N-acetyl cysteine (NAC 200 mg/2 ml vials) BID for one month
Intervention Type
Drug
Intervention Name(s)
N-acetyl cysteine (NAC)
Primary Outcome Measure Information:
Title
Change in the Smell Identification Test score
Description
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 )
Time Frame
Baseline and three months after completion of treatment
Secondary Outcome Measure Information:
Title
Change in Sino-Nasal Outcome Test (SNOT-20) score
Description
Validated quality of life assessment tool for nasal and sinus disease patients
Time Frame
Baseline and three months after completion of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley J Goldstein, MD, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami, Miller School of Medicine, Clinical Research Building
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
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NAC Trial for Anosmia
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