Clinical trial NCT04374474: Anosmia Rehabilitation in Patients Post Coronavirus Disease (COVID 19)
Official title: Olfactory Retraining Therapy and Budesonide Nasal Rinse for Anosmia Treatment in Patients Post-CoVID 19. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Olfactory Disorder
Keywords: anosmia
hyposmia
CoVID19
post-viral anosmia
snap and sniff olfactory test
budesonide
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from Baseline Snap and Sniff Threshold Test at 3 months
timeFrame: 3 months
measure: Change from baseline Smell Identification Test (SIT) at 3 months
timeFrame: 3 months
measure: Change from Baseline Snap and Sniff Threshold Test at 6 months
timeFrame: 6 months
measure: Change from baseline Smell Identification Test (SIT) at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline QOD-NS at 3 months
timeFrame: 3 months
measure: Change from baseline SF-36 health survey at 3 months
timeFrame: 3 months
measure: Change from baseline QOD-NS at 6 months
timeFrame: 6 months
measure: Change from baseline SF-36 health survey at 6 months
timeFrame: 6 months
measure: Adherence to the Study Protocol
timeFrame: 6 months
measure: Recovery
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Health Care
state: Ontario
Study officials:
affiliation: Western University
name: Leigh Sowerby, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.