- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04918953
Factors Influencing the Prognosis of Olfactory Dysfunction After Upper Sensation
Second Affiliated Hospital, College of Medicine, Zhejiang University
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All patients underwent nasal endoscopy and magnetic resonance imaging (MRI) of the olfactory pathway.
At least 1 week after the symptoms such as nasal congestion and runny nose subsided, olfactory disorders did not improve. Nasal sinusitis and other lesions were excluded by physical and endoscopic examinations and imaging (sinus computed tomography and MRI), and the disorder defined as post-infectious olfactory dysfunction. All participants had a clear history of upper respiratory tract infection; other causes of olfactory disorders were excluded.
All patients underwent a subjective olfactory test at the first visit and after the last treatment. The olfactory detection threshold and recognition threshold were tested using a T&T olfactory meter (Japan's First Drug Industry Co., Ltd.),which is commonly used in patients suffering from smelling disorders in asian, and correlate well with The University of Pennsylvania Smell Identification Test (UPSIT)[13]. The test was carried out according to the instructions on the olfactory meter, and the average recognition threshold of five olfactory elements was calculated to determine the degree of olfactory loss. The test results revealed normal (<1.0), mildly decreased (1.1 ≤ 2.5), moderately decreased (2.6 ≤ 4.0), severely decreased (4.1 ≤ 5.5), and complete lack of the sense of smell (> 5.5). In order to reduce the learning effects of repeated testing, all patients were order to close their eyes during the test.
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; and (3) budesonide atomization suspension (AstraZeneca Trading Co., Ltd.) 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[3].
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.
SAS 9.4 software was used for statistical analysis. The treatment plan was divided into three groups, and the dependent variable was a disordered three categorical variable. The description of the numerical variables of the normal distribution adopts the mean ± standard deviation, and the analysis of variance is used for statistical analysis; the description of the numerical variables of the non-normal distribution adopts the median (interquartile range), and the rank sum test of multi-sample comparison with a completely random design is adopted conduct statistical analysis. Categorical variables are described by R*C contingency table, and the chi-square test and Fisher exact probability method are used for statistical analysis. The alpha level of the statistical test is set to 0.05.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Hong-Gang Duan, doctor
- Phone Number: 86(China)-571-87783774
- Email: 2314061@zju.edu.cn
Study Contact Backup
- Name: Fang Ji, master
- Phone Number: 86(China)-571-87783774
- Email: 1506065@zju.edu.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310000
- Department of Otolaryngology, Second Affiliated Hospital, College of Medicine, Zhejiang University
-
Contact:
- Hong-Gang Duan, doctor
- Phone Number: 86(China)-571-87783774
- Email: 2314061@zju.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The history of upper respiratory tract infection was confirmed, and the previous sense of smell was normal.
Exclusion Criteria:
- Other causes of olfactory disorder suggested by the history
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: group 1
oral methylprednisolone, 40 mg for 3 days, 20 mg for 3 days, and 8 mg for 6 days
|
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
Other Names:
|
Experimental: group 2
oral methylprednisolone, 20 mg for 3 days, 10 mg for 3 days, and 4 mg for 6 days
|
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
Other Names:
|
Experimental: group 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.
|
(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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall effective rate
Time Frame: 5 years
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ze-xing Chen, master, Second Affiliated Hospital, College of Medicine, Zhejiang University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
- Budesonide
Other Study ID Numbers
- 2020-151
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Outcome
-
Lehigh Valley HospitalRecruitingPregnancy OutcomeUnited States
-
Oslo University HospitalCompleted
-
Bnai Zion Medical CenterUnknownAdverse Anesthesia Outcome
-
Bnai Zion Medical CenterUnknownAdverse Anesthesia Outcome
-
Bnai Zion Medical CenterCompletedAdverse Anesthesia OutcomeIsrael
-
Bnai Zion Medical CenterUnknownAdverse Anesthesia Outcome
-
Bnai Zion Medical CenterHospital Italiano de Buenos AiresCompletedAdverse Anesthesia Outcome
-
University of ZurichCompleted
-
Danat Al Emarat HospitalNot yet recruiting
-
JointResearchUppsala University; Göteborg University; Leiden University Medical Center; OLVGEnrolling by invitation
Clinical Trials on methylprednisolone
-
Rennes University HospitalUnknownMultiple Sclerosis, Relapsing-RemittingFrance
-
Chang Gung Memorial HospitalRecruitingMucocutaneous Lymph Node SyndromeTaiwan
-
Fred LublinPfizer; National Multiple Sclerosis SocietyTerminatedMultiple SclerosisUnited States
-
Assistance Publique - Hôpitaux de ParisCompleted
-
Universidad Nacional Autonoma de MexicoInstituto Nacional de Neurología y NeurocirugíaEnrolling by invitationMethylprednisolone | Intranasal Administration | Patients With an Active Multiple Sclerosis RelapseMexico
-
LEO PharmaBayerCompleted
-
Assiut UniversityCompleted
-
University of Colorado, DenverUniversity of Pennsylvania; MallinckrodtTerminatedMultiple SclerosisUnited States
-
Fundação de Medicina Tropical Dr. Heitor Vieira...CompletedSARS-CoV Infection | Severe Acute Respiratory Syndrome (SARS) PneumoniaBrazil
-
Peking University People's HospitalBeijing HospitalUnknownImmune Thrombocytopenia