Efficacy and Safety of Arbidol in the Treatment of Allergic Rhinitis

NCT06462417 | Recruiting

• 1 other identifier: Arbidol-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

The most important treatment for AR is topical nasal medications (including nasal corticosteroids, nasal antihistamines, nasal decongestants, and nasal saline irrigation etc.), which are still limited. Arbidol may inhibit molecular targets involved in the pathogenesis of AR. This study intends to explore the effect of Arbidol in the treatment of allergic rhinitis and evaluate its efficacy and safety.

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (3)

• The protein level of molecular biomarkers in nasal epithelial cells

  The level of molecular biomarkers in nasal epithelial cells at baseline (day 0, prior to treatment), day 14 will be measured by western blotting.

  14 days

• The mRNA level of inflammation molecular biomarkers in nasal epithelial cells

  The relative mRNA level of inflammatory cytokines (including IL-4, IL-13, CCL11, CCL24, CCL26 etc.) in nasal epithelial cells at baseline (day 0, prior to treatment), day 14 will be measured by Real-time PCR.

  14 days

• The level of inflammation molecular biomarkers in nasal lavage fluid

  Investigate the change of inflammation molecular biomarkers using sample of nasal lavage fluid. Biomarkers including IL-4, IL-13, CCL11, CCL24, CCL26 and IgE etc. in nasal lavage fluid at day 7 day 14 were detected to compare the changes of molecular indices relative to baseline at day 0.

  14 days

Secondary Outcomes (1)

• Changes from baseline in daily total nasal symptom score (TNSS) during 2 weeks of treatment.

  14 days

Study Arms (1)

Arbidol

EXPERIMENTAL

Arbidol Hydrochloride Tablets

Drug: Arbidol

Interventions

Arbidol DRUG

Arbidol Hydrochloride Tablets 0.2g/d for 2 weeks

Also known as: Arbidol Hydrochloride

Arbidol

Eligibility Criteria

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

You may qualify if:

• \. 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).
• \. 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).
• \. Female subjects are not pregnant or lactating and have no pregnancy and lactation plans during the trial medication period.
• \. 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.
• \. 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.

You may not qualify if:

• \. Who are allergic to Arbidol.
• \. 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).
• \. Patients with abnormal ECG parameters and clinically significant (PR\>220ms, QRS\>120ms, QTc\>450ms) and bradycardia.
• \. Patients with severe asthma or acute asthma exacerbations.
• \. 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.
• \. Patients with nasal polyps, severe deviated nasal septum, sinusitis, and hypertrophic rhinitis.
• \. Who have participated in other clinical studies within 3 months.
• \. Women are pregnant or lactating, in childbearing age with positive blood pregnancy test, or have pregnancy and lactation plans during the trial medication.
• \. Drug abuse and alcoholism.
• \. Who have received allergen-specific immunotherapy within 3 years.
• \. Positive infectious disease screening (hepatitis B surface antigen, hepatitis C antibody, AIDS antibody and treponema pallidum antibody).
• \. Who should not be included if there are other reasons in the opinion of the investigator.

Sponsors & Collaborators

• Zheng Liu: lead
• National Natural Science Foundation of China: collaborator

Study Sites (2)

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, 430000, China

RECRUITING

Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

umifenovir

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Zheng Liu, Doctor

  Tongji Hospital

  STUDY CHAIR

Central Study Contacts

Zheng Liu, Doctor

CONTACT

86 027 83663807; zhengliuent@hotmail.com

Ming Zeng, Doctor

CONTACT

86 027 83663807; zmsx77@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Otolaryngology-Head & Neck Surgery Vice Director Department of ENT Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: July 11, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

CN (2)