NAC Trial for Anosmia | NCT02481609

Studies
NAC Trial for Anosmia

NCT02481609

Sponsor

University of Miami

Status

Completed

Last Update Posted

Mar 20, 2018Actual

Enrollment

29Actual

Phase

Early Phase 1

Conditions

Anosmia

Interventions

N-acetyl cysteine (NAC)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Dec 1, 2017Actual

Completion Date

Dec 1, 2017Actual

First Submitted Date

Jun 22, 2015

First Submission Date that Met QC Criteria

Jun 22, 2015

First Posted Date

Jun 25, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2018

Last Update Posted Date

Mar 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NAC arm	Experimental	Topical intranasal N-acetyl cysteine (NAC 200 mg/2 ml vials) BID for one month	Drug: N-acetyl cysteine (NAC)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
N-acetyl cysteine (NAC)	Drug		NAC arm

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bradley J Goldstein, MD, PhD	University of Miami	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Miami, Miller School of Medicine, Clinical Research Building		Miami	Florida	33136	United States

Condition Browse Module

MeSH Terms

ID	Term
D000086582	Anosmia

Ancestor Terms

ID	Term
D000857	Olfaction Disorders
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000111	Acetylcysteine

Ancestor Terms

ID	Term
D003545	Cysteine
D000603	Amino Acids, Sulfur
D013457	Sulfur Compounds
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided