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

Capital Medical University

Status: Unknown

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

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT04002349

TR-Med-NAR-Cluster

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups, including a placebo group

A: Placebo group

Placebo Comparator group

Description:

Treated by 0.9% Natural saline (NS) nasal spray: 2 sprays each side daily in the morning

Treatment:

Drug: 0.9% natural saline

B: Budesonide Nasal Spray (Rhinocort)

Experimental group

Description:

Treated by Budesonide Nasal Spray (Rhinocort, Shanghai Johnson \& Johnson Pharmaceuticals, Ltd.) nasal spray: 2 sprays each side daily in the morning

Treatment:

Drug: Budesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)

C: Levocabastine Nasal Spray (Livostine)

Experimental group

Description:

Treated by Levocabastine(Livostinet, Shanghai Johnson \& Johnson Pharmaceuticals, Ltd.) Nasal Spray: 2 sprays each side daily in the morning

Treatment:

Drug: Levocabastine Nasal Spray (Livostine, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)

D: Combined Treatment

Experimental group

Description:

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

Treatment:

Drug: Budesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)

Drug: Levocabastine Nasal Spray (Livostine, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)