Determination of the Efficacy of Different Medications for Idiopathic RhinitisNCT04002349
Study of Medication for Nonallergic Rhinitis (NAR) Based on Cluster Analysis
A study testing Budesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.), Levocabastine Nasal Spray (Livostine, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.) and 0.9% natural saline in people with Determination of the Efficacy of Different Medications for Idiopathic Rhinitis and Impact of Different Medications on Biomarkers of Idiopathic Rhinitis, run by Beijing Tongren Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- 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
- What is being tested?
- Budesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.), Levocabastine Nasal Spray (Livostine, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.) and 0.9% natural saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2019to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Not younger than 18 years old
- Diagnosed as idiopathic rhinitis
- Signed and volunteered for the study
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Beijing Tongren Hospital
Beijing, Beijing Municipality, 100730
Luo Zhang, M.D., (86)13910830399, dr.luozhang@gmail.com
Luo Zhang, M.D.
- Recruiting
Yifan Meng
Beijing, Beijing Municipality, 100730
Yifan Meng, PhD, +8613581505557, mengyifan1015@126.com
Yifan Meng, PhD
About this study
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.
- Conditions
- 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
- Being tested
- Budesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.), Levocabastine Nasal Spray (Livostine, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.), 0.9% natural saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)Drug
Detailed in arm descriptions
Levocabastine Nasal Spray (Livostine, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)Drug
Detailed in arm descriptions
0.9% natural salineDrug
Detailed in arm descriptions
| Study group | Role | What they receive |
|---|---|---|
| A: Placebo group | Placebo comparator | Treated by 0.9% Natural saline (NS) nasal spray: 2 sprays each side daily in the morning Receives: Drug: 0.9% natural saline |
| B: Budesonide Nasal Spray (Rhinocort) | Experimental | Treated by Budesonide Nasal Spray (Rhinocort, Shanghai Johnson \& Johnson Pharmaceuticals, Ltd.) nasal spray: 2 sprays each side daily in the morning Receives: Drug: Budesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.) |
| C: Levocabastine Nasal Spray (Livostine) | Experimental | Treated by Levocabastine(Livostinet, Shanghai Johnson \& Johnson Pharmaceuticals, Ltd.) Nasal Spray: 2 sprays each side daily in the morning Receives: Drug: Levocabastine Nasal Spray (Livostine, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.) |
| D: Combined Treatment | Experimental | 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 Receives: Drug: Budesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.); Drug: Levocabastine Nasal Spray (Livostine, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of bothersome symptoms
Determined by change of visual analog scale for symptoms
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study start1 Jul 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Determination of the Efficacy of Different Medications for Idiopathic RhinitisStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Institute of Otolaryngology, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002349
- Sponsor's protocol ID
- TR-Med-NAR-Cluster
- Status last verified
- Jun 2019
- First submitted
- 27 Jun 2019
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Medication for Nonallergic Rhinitis (NAR) Based on Cluster Analysis
- ClinicalTrials.gov ID
- NCT04002349
- Acronym / sponsor ID
- TR-Med-NAR-Cluster
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Collaborators
- Beijing Institute of Otolaryngology, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A: Placebo group | Placebo comparator | Drug: 0.9% natural salineTreated by 0.9% Natural saline (NS) nasal spray: 2 sprays each side daily in the morning |
| B: Budesonide Nasal Spray (Rhinocort) | Experimental | Drug: Budesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)Treated by Budesonide Nasal Spray (Rhinocort, Shanghai Johnson \& Johnson Pharmaceuticals, Ltd.) nasal spray: 2 sprays each side daily in the morning |
| C: Levocabastine Nasal Spray (Livostine) | Experimental | Drug: Levocabastine Nasal Spray (Livostine, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)Treated by Levocabastine(Livostinet, Shanghai Johnson \& Johnson Pharmaceuticals, Ltd.) Nasal Spray: 2 sprays each side daily in the morning |
| D: Combined Treatment | Experimental | Drug: Budesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.), Drug: Levocabastine Nasal Spray (Livostine, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Not younger than 18 years old
- Diagnosed as idiopathic rhinitis
- Signed and volunteered for the study
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)Detailed in arm descriptions | Drug | B: Budesonide Nasal Spray (Rhinocort), D: Combined Treatment |
| Levocabastine Nasal Spray (Livostine, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)Detailed in arm descriptions | Drug | C: Levocabastine Nasal Spray (Livostine), D: Combined Treatment |
| 0.9% natural salineDetailed in arm descriptions | Drug | A: Placebo group |
Primary outcome
Relief of bothersome symptoms
Time frame: 2 weeks
Determined by change of visual analog scale for symptoms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2019.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Budesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.), Levocabastine Nasal Spray (Livostine, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.) and 0.9% natural saline in people with Determination of the Efficacy of Different Medications for Idiopathic Rhinitis and Impact of Different Medications on Biomarkers of Idiopathic Rhinitis, run by Beijing Tongren Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relief of bothersome symptoms (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2019.