Using Arbidol to treat allergic rhinitis

Study on the Efficacy and Safety of Oral Administration of Arbidol in the Treatment of Allergic Rhinitis Patients

This study is testing if Arbidol, a medicine usually used for the flu, can help people with allergic rhinitis feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Huazhong University of Science and Technology (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 2 sites (Wuhan, Hubei and 1 other locations)
• Trial ID: NCT06462417 on ClinicalTrials.gov

What this trial studies

This study explores the efficacy and safety of Arbidol, a medication traditionally used for influenza, in treating allergic rhinitis. Allergic rhinitis is a chronic inflammatory condition of the nasal mucosa that significantly affects patients' quality of life. The research aims to determine if Arbidol can inhibit molecular targets involved in the disease's pathogenesis, potentially providing a new treatment option. Participants will be evaluated based on their nasal symptoms and adherence to the study protocol.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with allergic rhinitis who exhibit moderate to severe nasal symptoms.

Not a fit: Patients with mild allergic rhinitis or those not meeting the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients suffering from allergic rhinitis.

How similar studies have performed: While the use of Arbidol for allergic rhinitis is novel, previous studies have shown its effectiveness in other conditions, suggesting potential for success in this application.

Eligibility criteria

Inclusion Criteria:

* 1\. Patients with allergic rhinitis (in line with the diagnostic criteria of the "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2015, Tianjin)" formulated by the Rhinology Group of the Otolaryngology-Head and Neck Surgery Branch of the Chinese Medical Association).
* 2\. At least 2 nasal symptoms are moderate or above (referring to sneezing, runny nose, nasal itching, nasal congestion with at least 2 symptoms ≥2 points).
* 3\. Female subjects are not pregnant or lactating and have no pregnancy and lactation plans during the trial medication period.
* 4\. The subject has not participated in other clinical trials in the previous three months and agrees not to participate in other clinical trials before reaching the endpoint of this trial.
* 5\. The subject/legally authorized representative understands the purpose and procedures of the trial and voluntarily signs the informed consent form, voluntarily participates in the study and complies with the study regulations, understands and complies with the medication dosage and follow-up plan, and correctly records the scale score, the number of medications, concomitant medication and adverse event records.

Exclusion Criteria:

* 1\. Who are allergic to Arbidol.
* 2\. Patients with abnormal liver and kidney function (ALT and AST exceed the maximum limit of normal value by 1.5 times, and Cr exceeds the upper limit of normal value).
* 3\. Patients with abnormal ECG parameters and clinically significant (PR\>220ms, QRS\>120ms, QTc\>450ms) and bradycardia.
* 4\. Patients with severe asthma or acute asthma exacerbations.
* 5\. Patients with structural heart disease, severe hypertension (blood pressure greater than 180/110mmHg), diabetes, hyperthyroidism, malignant tumors, immunocompromise, and mental illness. Patients with structural heart disease, severe hypertension (blood pressure greater than 180/110mmHg), diabetes, hyperthyroidism, malignant tumors, immunocompromise, and mental illness.
* 6\. Patients with nasal polyps, severe deviated nasal septum, sinusitis, and hypertrophic rhinitis.
* 7\. Who have participated in other clinical studies within 3 months.
* 8\. Women are pregnant or lactating, in childbearing age with positive blood pregnancy test, or have pregnancy and lactation plans during the trial medication.
* 9\. Drug abuse and alcoholism.
* 10\. Who have received allergen-specific immunotherapy within 3 years.
* 11\. Positive infectious disease screening (hepatitis B surface antigen, hepatitis C antibody, AIDS antibody and treponema pallidum antibody).
* 12\. Who should not be included if there are other reasons in the opinion of the investigator.

Where this trial is running

Wuhan, Hubei and 1 other locations

• Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology — Wuhan, Hubei, China (Recruiting)
• Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Zheng Liu, Doctor

Conditions Allergic Rhinitis