Allergic RhinitisNCT06462417
Efficacy and Safety of Arbidol in the Treatment of Allergic Rhinitis
A study testing Arbidol in people with Allergic Rhinitis, run by Zheng Liu at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Arbidol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesChina
- Study dates
- 11 Jul 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430000
Zeng Ming, chief physician, 86-027-83663807, zmsx77@163.com
- Recruiting
Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Zheng Liu, doctor, 86 027 83663807, zhengliuent@hotmail.com
Wang, Doctor
About this study
Official title: Study on the Efficacy and Safety of Oral Administration of Arbidol in the Treatment of Allergic Rhinitis Patients
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.
Read the detailed 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.
- Conditions
- Allergic Rhinitis
- Being tested
- Arbidol
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArbidolDrug
Also called Arbidol Hydrochloride
Arbidol Hydrochloride Tablets 0.2g/d for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Arbidol | Experimental | Arbidol Hydrochloride Tablets Receives: Drug: Arbidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start11 Jul 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zheng Liu
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Sponsor-investigator, Zheng Liu, Huazhong University of Science and Technology
- Investigators
- Zheng Liu, Doctor, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462417
- Sponsor's protocol ID
- Arbidol-01
- Status last verified
- May 2025
- First submitted
- 12 Jun 2024
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Safety of Oral Administration of Arbidol in the Treatment of Allergic Rhinitis Patients
- ClinicalTrials.gov ID
- NCT06462417
- Acronym / sponsor ID
- Arbidol-01
- Conditions
- Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Zheng LiuUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arbidol | Experimental | Drug: ArbidolArbidol Hydrochloride Tablets |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArbidolAlso: Arbidol HydrochlorideArbidol Hydrochloride Tablets 0.2g/d for 2 weeks | Drug | Arbidol |
Primary outcome
The protein level of molecular biomarkers in nasal epithelial cells
Time frame: 14 days
The level of molecular biomarkers in nasal epithelial cells at baseline (day 0, prior to treatment), day 14 will be measured by western blotting.
The mRNA level of inflammation molecular biomarkers in nasal epithelial cells
Time frame: 14 days
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.
The level of inflammation molecular biomarkers in nasal lavage fluid
Time frame: 14 days
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.
1 secondary outcome
Changes from baseline in daily total nasal symptom score (TNSS) during 2 weeks of treatment.
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
Related trials for Allergic Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Not yet recruitingObservational study
Prevelance of Bronchial Asthma and Allergic Rhinitis Among Children With Nephrotic Syndrom at Sohag University Hospital
Allergic Diseases in Nephrotic Children, Nephrotic Syndrom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zheng Liu, Doctor study chair
Tongji Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arbidol in people with Allergic Rhinitis, run by Zheng Liu at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zheng Liu, Doctor (86 027 83663807, zhengliuent@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The protein level of molecular biomarkers in nasal epithelial cells (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.