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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Budesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)
Levocabastine Nasal Spray (Livostine, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)
0.9% natural saline
Sponsored by
Beijing Tongren Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Determination of the Efficacy of Different Medications for Idiopathic Rhinitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Beijing Tongren HospitalRecruiting
  • Yifan MengRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

A: Placebo group

B: Budesonide Nasal Spray (Rhinocort)

C: Levocabastine Nasal Spray (Livostine)

D: Combined Treatment

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Relief of bothersome symptoms
Determined by change of visual analog scale for symptoms

Secondary Outcome Measures

Full Information

First Posted
June 27, 2019
Last Updated
June 27, 2019
Sponsor
Beijing Tongren Hospital
Collaborators
Beijing Institute of Otolaryngology, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04002349
Brief Title
Study of Medication for Nonallergic Rhinitis (NAR) Based on Cluster Analysis
Official Title
Study of Medication for Nonallergic Rhinitis (NAR) Based on Cluster Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
March 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tongren Hospital
Collaborators
Beijing Institute of Otolaryngology, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A: Placebo group
Arm Type
Placebo Comparator
Arm Description
Treated by 0.9% Natural saline (NS) nasal spray: 2 sprays each side daily in the morning
Arm Title
B: Budesonide Nasal Spray (Rhinocort)
Arm Type
Experimental
Arm Description
Treated by Budesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.) nasal spray: 2 sprays each side daily in the morning
Arm Title
C: Levocabastine Nasal Spray (Livostine)
Arm Type
Experimental
Arm Description
Treated by Levocabastine(Livostinet, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.) Nasal Spray: 2 sprays each side daily in the morning
Arm Title
D: Combined Treatment
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Budesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)
Intervention Description
Detailed in arm descriptions
Intervention Type
Drug
Intervention Name(s)
Levocabastine Nasal Spray (Livostine, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)
Intervention Description
Detailed in arm descriptions
Intervention Type
Drug
Intervention Name(s)
0.9% natural saline
Intervention Description
Detailed in arm descriptions
Primary Outcome Measure Information:
Title
Relief of bothersome symptoms
Description
Determined by change of visual analog scale for symptoms
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Beijing Tongren Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luo Zhang, M.D.
Phone
(86)13910830399
Email
dr.luozhang@gmail.com
First Name & Middle Initial & Last Name & Degree
Luo Zhang, M.D.
Facility Name
Yifan Meng
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yifan Meng, PhD
Phone
+8613581505557
Email
mengyifan1015@126.com
First Name & Middle Initial & Last Name & Degree
Yifan Meng, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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