AnosmiaEarly Phase 1NCT02481609
NAC Trial for Anosmia
A Early Phase 1 study testing N-acetyl cysteine (NAC) in people with Anosmia, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anosmia
- What is being tested?
- N-acetyl cysteine (NAC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 1 Dec 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Miami, Miller School of Medicine, Clinical Research Building
Miami, Florida, 33136
About this study
Official title: Pilot Study of Topical Intranasal N-acetyl Cysteine Administration for the Treatment of 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.
- Conditions
- Anosmia
- Being tested
- N-acetyl cysteine (NAC)
- Keywords
- Loss of Smell, Olfaction, Hyposmia
- Medical subject headings
- Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl cysteine (NAC)Drug
| Study group | Role | What they receive |
|---|---|---|
| NAC arm | Experimental | Topical intranasal N-acetyl cysteine (NAC 200 mg/2 ml vials) BID for one month Receives: Drug: N-acetyl cysteine (NAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: Baseline and three months after completion of treatment
Secondary outcomes (1)
Change in Sino-Nasal Outcome Test (SNOT-20) score
Validated quality of life assessment tool for nasal and sinus disease patients
Measured: Baseline and three months after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startJul 2014
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnosmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bradley Goldstein, University of Miami
- Investigators
- Bradley J Goldstein, MD, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481609
- Sponsor's protocol ID
- 20130996
- Status last verified
- Mar 2018
- First submitted
- 22 Jun 2015
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Topical Intranasal N-acetyl Cysteine Administration for the Treatment of Anosmia
- ClinicalTrials.gov ID
- NCT02481609
- Acronym / sponsor ID
- 20130996
- Conditions
- Anosmia
- Keywords
- Loss of Smell, Olfaction, Hyposmia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NAC arm | Experimental | Drug: N-acetyl cysteine (NAC)Topical intranasal N-acetyl cysteine (NAC 200 mg/2 ml vials) BID for one month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetyl cysteine (NAC) | Drug | NAC arm |
Primary outcome
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 )
1 secondary outcome
Change in Sino-Nasal Outcome Test (SNOT-20) score
Time frame: Baseline and three months after completion of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley J Goldstein, MD, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing N-acetyl cysteine (NAC) in people with Anosmia, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Smell Identification Test score (time frame: Baseline and three months after completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2018.