NAC Trial for Anosmia

University of Miami

Status and phase: Completed; Early Phase 1

Conditions: Anosmia

Treatments: Drug: N-acetyl cysteine (NAC)

Study type: Interventional

Funder types: Other

Identifiers

NCT02481609

20130996

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

NAC arm

Experimental group

Description:

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

Treatment:

Drug: N-acetyl cysteine (NAC)