CClinicalTrials.gg
Status unknownNCT04002349Updated Jun 28, 2019

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

An interventional study of Budesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.) and Levocabastine Nasal Spray (Livostine, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.) in Determination of the Efficacy of Different Medications for Idiopathic Rhinitis, Impact of Different Medications on Biomarkers of Idiopathic Rhinitis and Safety and Tolerance of Different Medications for Idiopathic Rhinitis, sponsored by Beijing Tongren Hospital. Status unknown at 2 sites in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-28.

Sponsored by Beijing Tongren Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • 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
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In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's planned enrollment of 80 is below the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Beijing Tongren Hospital is the lead sponsor of 154 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Not younger than 18 years old
  • Diagnosed as idiopathic rhinitis
  • Signed and volunteered for the study

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • 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

  • 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.)

  • 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.)

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

Interventions

  • DrugBudesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)

    Detailed in arm descriptions

  • DrugLevocabastine Nasal Spray (Livostine, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)

    Detailed in arm descriptions

  • Drug0.9% natural saline

    Detailed in arm descriptions

06

What researchers measure

Primary outcomes

  1. Relief of bothersome symptoms

    Determined by change of visual analog scale for symptoms

    Time frame: 2 weeks

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Study locations

2 of 2 sites recruiting
  • Beijing Tongren Hospital
    Beijing, Beijing 100730, China
    • Luo Zhang, M.D. · Contact · dr.luozhang@gmail.com · (86)13910830399
    • Luo Zhang, M.D. · Principal investigator
    Recruiting
  • Yifan Meng
    Beijing, Beijing 100730, China
    • Yifan Meng, PhD · Contact · mengyifan1015@126.com · +8613581505557
    • Yifan Meng, PhD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04002349
Lead sponsor
Beijing Tongren Hospital
Collaborators
Beijing Institute of Otolaryngology, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.
Responsible party
Sponsor
First posted
Jun 28, 2019
Start date
Jul 1, 2019 (estimated)
Primary completion
Dec 31, 2019 (estimated)
Completion
Mar 31, 2020 (estimated)
Last update
Jun 28, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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