- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04002349
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
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
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Recruiting
- Beijing Tongren Hospital
-
Contact:
- Luo Zhang, M.D.
- Phone Number: (86)13910830399
- Email: dr.luozhang@gmail.com
-
Principal Investigator:
- Luo Zhang, M.D.
-
Beijing, Beijing, China, 100730
- Recruiting
- Yifan Meng
-
Contact:
- Yifan Meng, PhD
- Phone Number: +8613581505557
- Email: mengyifan1015@126.com
-
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
|
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
|
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
|
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
|
Detailed in arm descriptions
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.
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
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Otorhinolaryngologic Diseases
- Picornaviridae Infections
- Nose Diseases
- Rhinitis
- Common Cold
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Budesonide
- Levocabastine
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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