Study of Medication for Nonallergic Rhinitis (NAR) Based on Cluster Analysis

Study Overview
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Brief Summary
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Chronic rhinitis (CR) is one of the most common nasal mucosal diseases in the world. In China, about 140 million people suffer from this disease. Chronic rhinitis can lead to severe economic and social burden, as well as the potential risk of developing other chronic diseases such as asthma and chronic sinusitis. Therefore, it is of great significance to explore the classification and treatment strategies of chronic rhinitis in order to improve the health level of Chinese people.

Official Title
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Study of Medication for Nonallergic Rhinitis (NAR) Based on Cluster Analysis

Conditions
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Determination of the Efficacy of Different Medications for Idiopathic Rhinitis, Impact of Different Medications on Biomarkers of Idiopathic Rhinitis, Safety and Tolerance of Different Medications for Idiopathic Rhinitis

Intervention / Treatment
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* Drug: Budesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)
* Drug: Levocabastine Nasal Spray (Livostine, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)
* Drug: 0.9% natural saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Not younger than 18 years old Diagnosed as idiopathic rhinitis Signed and volunteered for the study Exclusion Criteria: Comorbid airway diseases including (but not limited to) upper airway infection, chronic rhinosinusitis, nasal polyps Allergic to the medicines about to study Having used oral glucocorticoids or antihistamine agents within 30 days of the enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A: Placebo group<br>Treated by 0.9% Natural saline (NS) nasal spray: 2 sprays each side daily in the morning | Drug: 0.9% natural saline<br>* Detailed in arm descriptions<br>|
| Experimental: B: Budesonide Nasal Spray (Rhinocort)<br>Treated by Budesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.) nasal spray: 2 sprays each side daily in the morning | Drug: Budesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)<br>* Detailed in arm descriptions<br>|
| Experimental: C: Levocabastine Nasal Spray (Livostine)<br>Treated by Levocabastine(Livostinet, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.) Nasal Spray: 2 sprays each side daily in the morning | Drug: Levocabastine Nasal Spray (Livostine, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)<br>* Detailed in arm descriptions<br>|
| Experimental: D: Combined Treatment<br>Treated by Budesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.) nasal spray: 2 sprays each side daily in the morning and Levocabastine(Livostinet, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.) Nasal Spray: 2 sprays each side daily in the morning | Drug: Budesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)<br>* Detailed in arm descriptions<br>Drug: Levocabastine Nasal Spray (Livostine, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)<br>* Detailed in arm descriptions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief of bothersome symptoms | Determined by change of visual analog scale for symptoms | 2 weeks |