Factors Influencing the Prognosis of Olfactory Dysfunction After Upper Sensation

NCT04918953 | Not Yet Recruiting Phase 2

• 1 other identifier: 2020-151
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: This study aimed to analyze the outcomes of post-infectious olfactory dysfunction treated with different doses of corticosteroids and specify factors related to the curative effect. Methods: The medical records of patients diagnosed with post-infectious olfactory dysfunction from January 2020 to december 2025 were reviewed. All patients were treated with different doses of oral corticosteroids for 12 days or they inhaled corticosteroids for 1 month.

Conditions

Outcome

Keywords

Corticosteroid, olfactory dysfunction, Smell.

Outcome Measures

Primary Outcomes (1)

• overall effective rate

  A repeat T\&T subjective olfactory test will be performed after the treatment. Patients with normal sense of smell will be defined as cured; patients with average T\&T recognition threshold decreased by 1 point will be defined as improved; patients with average T\&T recognition threshold decreased by 2 points or more, which did not reach the normal range, will be defined as significantly improved; and patients with average T\&T recognition threshold decreased by 1 point, with or without falling, will be defined as invalid.

  5 years

Study Arms (3)

group 1

EXPERIMENTAL

oral methylprednisolone, 40 mg for 3 days, 20 mg for 3 days, and 8 mg for 6 days

Drug: methylprednisolone

group 2

EXPERIMENTAL

oral methylprednisolone, 20 mg for 3 days, 10 mg for 3 days, and 4 mg for 6 days

Drug: methylprednisolone

group 3

EXPERIMENTAL

budesonide atomization suspension (AstraZeneca Trading Co., Ltd, AU.) inhaled through the nose atomized with an air compression atomizer for 4 weeks, 2 mg for the first 2 weeks and reduced to 1 mg for the last 2 weeks.

Drug: budesonide atomization suspension

Interventions

methylprednisolone DRUG

The patients were treated with three protocols: (1) oral methylprednisolone, 40 mg for 3 days, 20 mg for 3 days, and 8 mg for 6 days; (2) oral methylprednisolone, 20 mg for 3 days, 10 mg for 3 days, and 4 mg for 6 days. At the same time, all patients received olfactory training for 12 weeks as proposed by Hummel et al

Also known as: Olfactory training

group 1; group 2

budesonide atomization suspension DRUG

(3) budesonide atomization suspension (AstraZeneca Trading Co., Ltd, AU.) inhaled through the nose atomized with an air compression atomizer for 4 weeks, 2 mg for the first 2 weeks and reduced to 1 mg for the last 2 weeks. At the same time, all patients received olfactory training for 12 weeks as proposed by Hummel et al

Also known as: Olfactory training

group 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The history of upper respiratory tract infection was confirmed, and the previous sense of smell was normal.

You may not qualify if:

• Other causes of olfactory disorder suggested by the history

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Department of Otolaryngology, Second Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Anosmia

Interventions

Methylprednisolone; Olfactory Training

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Therapeutics

Study Officials

• Ze-xing Chen, master

  Second Affiliated Hospital, College of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong-Gang Duan, doctor

CONTACT

86(China)-571-87783774; 2314061@zju.edu.cn

Fang Ji, master

CONTACT

86(China)-571-87783774; 1506065@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 9, 2021
• Study Start: June 2, 2021
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 9, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)