Efficacy and Safety of Arbidol in the Treatment of Allergic Rhinitis

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06462417
• Other study ID #: Arbidol-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 20, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: Huazhong University of Science and Technology
• Contact: Zheng Liu, Doctor
• Phone: 86 027 83663807
• Email: zhengliuent[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Allergic rhinitis (AR) is a non-infectious inflammatory disease of the nasal mucosa mediated by Immunoglobulin E after exposure to allergens. AR has become a major chronic inflammatory disease of the respiratory tract, which has a serious impact on the quality of life of patients and social economy. The most important treatment for AR is topical nasal medications (including nasal corticosteroids, nasal antihistamines, nasal decongestants, and nasal saline irrigation etc.). However, even if patients are treated completely according to the standard diagnosis and treatment strategy, a considerable number of patients still do not achieve satisfactory treatment results. Arbidol is a medicine for the prevention and treatment of influenza. Based on our previous laboratory data, Arbidol may inhibit molecular targets involved in the pathogenesis of AR. In order to make the treatment of AR more effective, timely and convenient, this study intends to explore the effect of Arbidol in the treatment of allergic rhinitis and evaluate its efficacy and safety.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Arbidol
Arbidol Hydrochloride Tablets 0.2g/d for 2 weeks

Locations

Country	Name	City	State
China	Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Zheng Liu	National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Changes from baseline in daily total nasal symptom score (TNSS) during 2 weeks of treatment.	The TNSS for allergic rhinitis was used to evaluate the rhinitis-related symptoms and quantity of life scores. Changes from baseline in daily total nasal symptom score (TNSS) during 2 weeks of treatment. The Total Nasal Symptom Score (TNSS) is the sum of four symptom scores, rhinorrhea, nasal congestion, nasal itching, and sneezing, where each symptom is scored on a scale of 0 to 3.	14 days