Otitis Media with Effusion
Conditions
Interventions
Control Groups:N/A
Intervention Groups:IL-4Ra Monoclonal Antibody (Spectrobab) Injection
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old=100 IU/mL); 4. The presence of obvious symptoms, such as a feeling of ear stuffiness, hearing loss, and tinnitus. 5. The tympanic membrane of both ears was intact, and none of them had undergone ear surgery such as tympanic tube placement; 6. The patients voluntarily participated in the study, signed a written informed consent form, and were willing to cooperate with the follow-up. 7. Each subject must meet the above inclusion criteria to be eligible for the study.
Exclusion criteria
Exclusion criteria: 1. A combination of other otological diseases such as tympanic membrane perforation, cholesteatoma, middle ear tumour, or other organic middle ear disease 2. Nasopharyngeal space-occupying lesions (e.g., nasopharyngeal carcinoma) or history of previous head and neck radiotherapy; 3. Acute upper respiratory tract infection or localised infection of the middle ear within 2 weeks before screening, e.g., acute otitis media or active chronic suppurative otitis media; 4. Patients with sensorineural deafness; 5. Loss of visits before completion of 6 months of observation; 6. Patients with hepatic or renal insufficiency, severe immunodeficiency, or poor general condition that makes it difficult for them to tolerate the treatment; 7. Patients who are allergic to Spectrobab or its excipients or have a history of severe allergic reactions; 8. Patients with mental disorders and other patients who are unable to cooperate with the medication and examination; 9. Women who are breastfeeding, pregnant, or may become pregnant; 10. Those who have participated in any clinical drug trial within the last three months; 11. Use of systemic hormones or immunosuppressive agents within 4 weeks before screening. 12. Any other condition that, in the opinion of the investigator, makes the trial unsuitable. 13. Subjects who meet any of the above exclusion criteria at baseline will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clearance of middle ear effusion;Adverse event rates;Hearing improvement; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease recurrence rate;Relief of ear symptoms; | — |
Countries
China
Contacts
Public ContactSun Yu
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed