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Efficacy and Safety of Arbidol in the Treatment of Allergic Rhinitis

ConditionAllergic Rhinitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorZheng Liu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Arbidol

    Drug

    Arbidol Hydrochloride Tablets 0.2g/d for 2 weeks

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: ArbidolExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
14 days
2

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.

Time frame
14 days
3

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.

Time frame
14 days

Secondary outcomes

1

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.

Time frame
14 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zheng Liu

Lead sponsor

Huazhong University of Science and Technology

Sponsor institution

National Natural Science Foundation of China

Collaborator

Source ClinicalTrials.gov
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