NAC Trial for Anosmia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Anosmia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NAC arm

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

Group Type EXPERIMENTAL

N-acetyl cysteine (NAC)

Intervention Type DRUG

Interventions

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N-acetyl cysteine (NAC)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No