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Olfactory DisorderPhase 4NCT04374474

Anosmia Rehabilitation in Patients Post Coronavirus Disease (COVID 19)

A Phase 4 study testing Olfactory retraining, corticosteroid nasal irrigation and smell household Items in people with Olfactory Disorder, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The study will be a randomized controlled trial, involving patients with hyposmia/anosmia of onset immediately after an upper respiratory viral illness, assigned to three distinct study arms. Nasal irrigations will be prescribed to all three groups (BID). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Olfactory Disorder
What is being tested?
Olfactory retraining, corticosteroid nasal irrigation and smell household Items
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteCanada
Study dates
10 Jan 2021to 10 Mar 2022
Phase
Phase 4
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 18 years of age or older
  • Hyposmia/anosmia of onset immediately after an upper respiratory viral illness confirmed on Snap n' Sniff threshold testing,
  • Capable, in the opinion of the primary investigator, of providing informed consent to participate in the study. Participants are required to sign an informed consent form indicating they understand the purpose and nature of the study, and that they are willing to participate.

Who cannot join

  • active cigarette smoker
  • chronic rhinosinusitis
  • head trauma with loss of consciousness
  • inability to read/understand English
  • previous hyposmia/anosmia complaint
  • pregnancy
Show all 9Show fewer
  • previous sinus
  • skull base or brain surgery
  • current participation in another clinical trial at the time of initial visit

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Joseph's Health Care

    London, Ontario, N5A 4V2

Other trials in Canada

About this study

Official title: Olfactory Retraining Therapy and Budesonide Nasal Rinse for Anosmia Treatment in Patients Post-CoVID 19. A Randomized Controlled Trial

The study will be a randomized controlled trial, involving patients with hyposmia/anosmia of onset immediately after an upper respiratory viral illness, assigned to three distinct study arms. Nasal irrigations will be prescribed to all three groups (BID). In addition, one arm will receive a paper hand-out about post-viral anosmia with instructions to smell common household items (current care) and act as a control group. The second group will receive an essential oil retraining kit, whereas the third group will receive the same olfactory training kit and a prescription to use budesonide with the nasal irrigations. Olfactory scores will be tested at the enrollment, 3 months and at 6 months.

Being tested
Olfactory retraining, corticosteroid nasal irrigation, smell household Items, Nasal Irrigation
Keywords
anosmia, hyposmia, CoVID19, post-viral anosmia, snap and sniff olfactory test, budesonide
Medical subject headings
Anosmia, COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Olfactory retrainingOther

    Also called essential oils kit, smell training

    Olfactory retraining Olfactory training is performed by exposing patients twice daily to essential oils with four specific odors, present in glass jars with soaked cotton pads: phenyl ethyl alcohol, rose; eucalyptol, eucalyptus; citronellal, lemon; eugenol, cloves.

  • corticosteroid nasal irrigationDrug

    Also called Budesonide nasal irrigation

    Nasal irrigation with corticosteroid (budesonide) consists of 240-mL nasal irrigation with Pulmicort Respules (0.5mg) across both nose sides via NeilMed Sinus Rinse bottle (Santa Rosa, California, USA).

  • smell household ItemsOther

    Participants will receive a paper hand-out about post-viral anosmia with instructions to smell common household items

  • Nasal IrrigationOther

    Also called Nasal Rinse

    Participants from all three groups will use nasal rinse (NeilMed Sinus Rinse) two times a day.

Study groups in NCT04374474
Study groupRoleWhat they receive
Control GroupSham comparatorThe participants, randomly assigned to this arm, will receive a paper hand-out about post-viral anosmia with instructions to smell common household items (current care). Besides, it will be prescribed nasal irrigation twice a day.
Receives: Other: smell household Items; Other: Nasal Irrigation
Olfactory Retraining GroupExperimentalThe participants, randomly assigned to this arm, will receive instructions on olfactory retraining and will also be given an essential oil retraining kit, which they will use twice a day. Besides, it will be prescribed nasal irrigation twice a day.
Receives: Other: Olfactory retraining; Other: Nasal Irrigation
Olfactory Retraining_Budesonide GroupExperimentalThe participants, randomly assigned to this arm, will receive instructions on olfactory retraining, the olfactory training kit and it will be prescribed nasal irrigation with Budesonise, twice a day.
Receives: Other: Olfactory retraining; Drug: corticosteroid nasal irrigation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline Snap and Sniff Threshold Test at 3 months

    Score from the Snap and Sniff Olfactory Test results

    Measured: 3 months

  2. Change from baseline Smell Identification Test (SIT) at 3 months

    Score from the Smell Identification test results.

    Measured: 3 months

  3. Change from Baseline Snap and Sniff Threshold Test at 6 months

    Score from the Snap and Sniff Olfactory Test results

    Measured: 6 months

  4. Change from baseline Smell Identification Test (SIT) at 6 months

    Score from the Smell Identification test results.

    Measured: 6 months

Secondary outcomes (6)

  1. Change from baseline QOD-NS at 3 months

    Scores from the short version of the Questionnaire of Olfactory Disorders Negative Statements (QOD-NS)

    Measured: 3 months

  2. Change from baseline SF-36 health survey at 3 months

    Short Form 36 Health Survey scores

    Measured: 3 months

  3. Change from baseline QOD-NS at 6 months

    Scores from the short version of the Questionnaire of Olfactory Disorders Negative Statements (QOD-NS)

    Measured: 6 months

  4. Change from baseline SF-36 health survey at 6 months

    Short Form 36 Health Survey scores

    Measured: 6 months

  5. Adherence to the Study Protocol

    Adherence comparison between participants post-CoVID 19 and patients post other viral infections.

    Measured: 6 months

  6. Recovery

    Compare the rate of recovery between post-COVID 19 patients and patients post other viral infections.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2020
  2. Study start10 Jan 2021 (estimated)
  3. Primary completion10 Dec 2021 (estimated)
  4. Study completion10 Mar 2022 (estimated)

Why it stopped: Study withdrawn before any enrollment (site's research goals adjustments).

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04374474
Sponsor's protocol ID
Anosmia_CoVID 19
Status last verified
Oct 2024
First submitted
29 Apr 2020
Last updated
1 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Vennemann MM, Hummel T, Berger K. The association between smoking and smell and taste impairment in the general population. J Neurol. 2008 Aug;255(8):1121-6. doi: 10.1007/s00415-008-0807-9. Epub 2008 Jul 28.

    PubMed 18677645

  • Croy I, Nordin S, Hummel T. Olfactory disorders and quality of life--an updated review. Chem Senses. 2014 Mar;39(3):185-94. doi: 10.1093/chemse/bjt072. Epub 2014 Jan 15.

    PubMed 24429163

  • Konstantinidis I, Tsakiropoulou E, Bekiaridou P, Kazantzidou C, Constantinidis J. Use of olfactory training in post-traumatic and postinfectious olfactory dysfunction. Laryngoscope. 2013 Dec;123(12):E85-90. doi: 10.1002/lary.24390. Epub 2013 Oct 4.

    PubMed 24114690

  • Nguyen TP, Patel ZM. Budesonide irrigation with olfactory training improves outcomes compared with olfactory training alone in patients with olfactory loss. Int Forum Allergy Rhinol. 2018 Sep;8(9):977-981. doi: 10.1002/alr.22140. Epub 2018 Jun 14.

    PubMed 29901865

  • Mattos JL, Edwards C, Schlosser RJ, Hyer M, Mace JC, Smith TL, Soler ZM. A brief version of the questionnaire of olfactory disorders in patients with chronic rhinosinusitis. Int Forum Allergy Rhinol. 2019 Oct;9(10):1144-1150. doi: 10.1002/alr.22392. Epub 2019 Aug 20.

    PubMed 31430061

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Olfactory retraining, corticosteroid nasal irrigation and smell household Items in people with Olfactory Disorder, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

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 9 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: withdrawn, as of the sponsor's last update on 1 Aug 2025. 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 Canada. 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. Some participants in this study may receive a placebo. 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?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 was withdrawn before enrolling participants, so there are no results.

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 from Baseline Snap and Sniff Threshold Test at 3 months (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04374474, which also lists 5 linked publications.

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 1 Aug 2025.

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