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Completed

NCT Number: NCT02481609

NAC Trial for Anosmia

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

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

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N-Acetyl Cysteine (NAC)

Drug

Primary outcomes

  1. Change in the Smell Identification Test score

    Time frame: Baseline and three months after completion of treatment

    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 outcomes

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

    Time frame: Baseline and three months after completion of treatment

    Validated quality of life assessment tool for nasal and sinus disease patients

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Pilot Study of Topical Intranasal N-acetyl Cysteine Administration for the Treatment of Anosmia

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 25, 2015
Registry last updated
Mar 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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