Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2020-08-08
2020-11-03
Brief Summary
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Detailed Description
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Complete medical history will be taken, and essential clinical assessment with appropriate protective measures will be performed in all patients.The patients in the study will be randomly divided into two groups: - Group I: -who will receive topical corticosteroid nasal spray (mometasone furoate nasal spray) beside olfactory training Group II: -who will not receive topical corticosteroid nasal spray but only olfactory training.
As regards the assessment of smell,the patient will assess his smell sensation using familiar substances with distinctive odor. A jar of coffee, a branch of mint and garlic are some used substances. The patient will report the degree of anosmia subjectively with score on a scale from 0 to 10.The assessment of smell will be done initially after recovery/discharge, after 1 week, 2 weeks and after 3 weeks for all patients. The duration of smell loss will be recorded from the onset of anosmia till full recovery of the sensation.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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mometasone nasal spray
Patients will receive topical corticosteroid nasal spray (mometasone furoate nasal spray) in appropriate dose of 2 puff in each nostril (100 µg once daily) beside olfactory training.
mometasone furoate nasal spray
dose of 2 puff in each nostril (100 µg once daily each nostril).
control
Patients will not receive topical corticosteroid nasal spray but only olfactory training.
No interventions assigned to this group
Interventions
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mometasone furoate nasal spray
dose of 2 puff in each nostril (100 µg once daily each nostril).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* confirmed case (+ve PCR),
* recovered/discharged (2 -ve PCR),
* suffered from sudden recent anosmia or hyposmia
Exclusion Criteria
* with previous chronic rhinological pathologies,
* patients on systemic steroid for previous systemic disease,
* anosmia improved before COVID19 recovery,
* pregnancy
* patients who will not complete the follow up period.
18 Years
ALL
No
Sponsors
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Benha University
OTHER
Responsible Party
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Abdelrahman Ahmed Abdelalim
MD lecturer
Principal Investigators
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Abdelrahman A Abdelalim, MD
Role: PRINCIPAL_INVESTIGATOR
Benha University
Rasha A Elsayed, MD
Role: STUDY_CHAIR
Benha University
Mona A Elawady, MD
Role: STUDY_CHAIR
Benha University
Abdelhakim F Ghallab, MD
Role: STUDY_CHAIR
Benha University
Ayman A Mohamady, MD
Role: STUDY_CHAIR
Benha University
Locations
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Benha University Hospital, Faculty of Medicine
Banhā, Qalyubia Governorate, Egypt
Countries
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References
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Heilmann S, Just T, Goktas O, Hauswald B, Huttenbrink KB, Hummel T. [Effects of systemic or topical administration of corticosteroids and vitamin B in patients with olfactory loss]. Laryngorhinootologie. 2004 Nov;83(11):729-34. doi: 10.1055/s-2004-825676. German.
Hura N, Xie DX, Choby GW, Schlosser RJ, Orlov CP, Seal SM, Rowan NR. Treatment of post-viral olfactory dysfunction: an evidence-based review with recommendations. Int Forum Allergy Rhinol. 2020 Sep;10(9):1065-1086. doi: 10.1002/alr.22624. Epub 2020 Jun 25.
Webster KE, O'Byrne L, MacKeith S, Philpott C, Hopkins C, Burton MJ. Interventions for the prevention of persistent post-COVID-19 olfactory dysfunction. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD013877. doi: 10.1002/14651858.CD013877.pub3.
Abdelalim AA, Mohamady AA, Elsayed RA, Elawady MA, Ghallab AF. Corticosteroid nasal spray for recovery of smell sensation in COVID-19 patients: A randomized controlled trial. Am J Otolaryngol. 2021 Mar-Apr;42(2):102884. doi: 10.1016/j.amjoto.2020.102884. Epub 2021 Jan 4.
Other Identifiers
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RC 4-7-2020
Identifier Type: -
Identifier Source: org_study_id