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

June 27, 2019 updated by: Beijing Tongren Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Beijing Tongren Hospital
        • Contact:
        • Principal Investigator:
          • Luo Zhang, M.D.
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Yifan Meng
        • Contact:
        • Principal Investigator:
          • Yifan Meng, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tongren Hospital

Collaborators

Beijing Institute of Otolaryngology
Shanghai Johnson & Johnson Pharmaceuticals, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2019

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

March 31, 2020

Study Registration Dates

First Submitted

June 27, 2019

First Submitted That Met QC Criteria

June 27, 2019

First Posted (Actual)

June 28, 2019

Study Record Updates

Last Update Posted (Actual)

June 28, 2019

Last Update Submitted That Met QC Criteria

June 27, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TR-Med-NAR-Cluster

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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