Anosmia Rehabilitation in Patients Post Coronavirus Disease (COVID 19)

NCT04374474 | Withdrawn Phase 4 DMC

• 1 other identifier: Anosmia_CoVID 19
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Olfactory Disorder

Keywords

anosmia; hyposmia; CoVID19; post-viral anosmia; snap and sniff olfactory test; budesonide

Outcome Measures

Primary Outcomes (4)

• Change from Baseline Snap and Sniff Threshold Test at 3 months

  Score from the Snap and Sniff Olfactory Test results

  3 months

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

  Score from the Smell Identification test results.

  3 months

• Change from Baseline Snap and Sniff Threshold Test at 6 months

  Score from the Snap and Sniff Olfactory Test results

  6 months

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

  Score from the Smell Identification test results.

  6 months

Secondary Outcomes (6)

• Change from baseline QOD-NS at 3 months

  3 months

• Change from baseline SF-36 health survey at 3 months

  3 months

• Change from baseline QOD-NS at 6 months

  6 months

• Change from baseline SF-36 health survey at 6 months

  6 months

• Adherence to the Study Protocol

  6 months

Study Arms (3)

Control Group

SHAM COMPARATOR

The 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.

Other: smell household Items; Other: Nasal Irrigation

Olfactory Retraining Group

EXPERIMENTAL

The 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.

Other: Olfactory retraining; Other: Nasal Irrigation

Olfactory Retraining_Budesonide Group

EXPERIMENTAL

The 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.

Other: Olfactory retraining; Drug: corticosteroid nasal irrigation

Interventions

Olfactory retraining OTHER

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.

Also known as: essential oils kit, smell training

Olfactory Retraining Group; Olfactory Retraining_Budesonide Group

corticosteroid nasal irrigation DRUG

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).

Also known as: Budesonide nasal irrigation

Olfactory Retraining_Budesonide Group

smell household Items OTHER

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

Control Group

Nasal Irrigation OTHER

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

Also known as: Nasal Rinse

Control Group; Olfactory Retraining Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

Study Sites (1)

St. Joseph's Health Care

London, Ontario, N5A 4V2, Canada

Location

Related Publications (5)

• 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.

  PMID: 18677645 BACKGROUND

• 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.

  PMID: 24429163 BACKGROUND

• 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.

  PMID: 24114690 BACKGROUND

• 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.

  PMID: 29901865 BACKGROUND

• 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.

  PMID: 31430061 BACKGROUND

Related Links

• Snap and Sniff threshold test informative website

MeSH Terms

Conditions

Anosmia; COVID-19

Interventions

Olfactory Training; Nasal Lavage

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Therapeutic Irrigation; Investigative Techniques

Study Officials

• Leigh Sowerby, MD, FRCSC

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 5, 2020
• Study Start: January 10, 2021
• Primary Completion: December 10, 2021
• Study Completion: March 10, 2022
• Last Updated: August 1, 2025

Record last verified: 2024-10

Locations

CA (1)