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Allergic RhinitisPhase 4NCT05038202

Study of Bencycloquidium Bromide Nasal Spray in the Treatment of Moderate-severe Persistent Allergic Rhinitis

A Phase 4 study testing Bencycloquidium Bromide Nasal Spray and Mometasone Furoate Aqueous Nasal Spray in people with Allergic Rhinitis, run by Yingu Pharmaceutical Co., Ltd at 6 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

450 subjects with moderate-severe persistent allergic rhinitis will be enrolled in the trial and divided into three groups for different treatments. Group A：Subjects with Bencycloquidium Bromide Nasal Spray, Group B：Subjects with Mometasone Furoate Aqueous Nasal Spray, Group C：Subjects with Bencycloquidium Bromide… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Allergic Rhinitis
What is being tested?
Bencycloquidium Bromide Nasal Spray and Mometasone Furoate Aqueous Nasal Spray
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
6 sitesChina
Study dates
16 Jun 2021to 30 Jun 2024
Phase
Phase 4
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The diagnosis of allergic rhinitis meets the standards of "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis" (2015, Tianjin);
  • The previous or current symptom onset is ≥4d/week and ≥4 consecutive weeks; the symptoms are severe or serious (Total Nasal Symptom Scores≥6 points) with single symptom score of runny nose ≥2 points;
  • Able to complete the symptom score as required;
  • Subjects voluntarily participate in this study, and sign a written informed consent form. Use study drugs, complete evaluation and follow-up in accordance with the requirements of this study.

Who cannot join

  • Those who are known to be allergic to the ingredients contained in test drugs.
  • Used vasoconstrictors within 1 day; used topical or oral antihistamines within 3 days; used topical glucocorticoids and leukotriene receptor antagonists within 7 days; used oral glucocorticoid drugs within 30 days.
  • Those who have been diagnosed as asthma or have asthma symptoms (wheezing, shortness of breath, chest tightness, coughing).
  • Patients suffering from respiratory infections or abnormal nasal anatomy (such as nasal polyps, nasal septum deviation, etc.) one month before enrollment.
  • Received immunotherapy and nasal surgery Within 6 months before enrollment.
  • Patients with dry eye.
Show all 11Show fewer
  • Patients with glaucoma.
  • Patients with enlarged prostate who have difficulty urinating.
  • People with mental disorders or impaired consciousness.
  • Pregnancy (patients report pregnancy), those who have a pregnancy plan within 6 months, and lactating women.
  • Patients considered by the researcher to be unsuitable to participate in this study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Beijing friendship hospital, CMU

    Beijing, Beijing Municipality

  • Beijing Shijitan Hospital,CMU

    Beijing, Beijing Municipality

  • Beijing Tongren Hospital,CMU

    Beijing, Beijing Municipality

  • The third affliation hospital of Sun YAT-SEN university

    Guangzhou, Guangdong

  • Jiangsu Province hospital

    Nanjing, Jiangsu

  • Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei

Other trials in China

About this study

Official title: Study on the Efficacy and Safety of Bencycloquidium Bromide Nasal Spray Alone or in Combination With Mometasone Furoate Aqueous Nasal Spray in the Treatment of Moderate-severe Persistent Allergic Rhinitis

450 subjects with moderate-severe persistent allergic rhinitis will be enrolled in the trial and divided into three groups for different treatments. Group A：Subjects with Bencycloquidium Bromide Nasal Spray, Group B：Subjects with Mometasone Furoate Aqueous Nasal Spray, Group C：Subjects with Bencycloquidium Bromide Nasal Spray in combination with Mometasone Furoate Aqueous Nasal Spray.The main purpose of the trial is to evaluate the efficacy of Bencycloquidium Bromide Nasal Spray alone or in combination with Mometasone Furoate Aqueous Nasal Spray in the treatment of moderate-severe persistent allergic rhinitis and rhinorrhea.

Read the detailed description

The Secondary purpose is to evaluate the effectiveness of Bencycloquidium Bromide Nasal Spray alone or in combination with Mometasone Furoate Aqueous Nasal Spray in the treatment of moderate-severe persistent allergic rhinitis with nasal itching, nasal congestion, and sneezing. And evaluate the safety of Bencycloquidium Bromide Nasal Spray alone or in combination with Mometasone Furoate Aqueous Nasal Spray.

Being tested
Bencycloquidium Bromide Nasal Spray, Mometasone Furoate Aqueous Nasal Spray
Keywords
allergic rhinitis, Bencycloquidium Bromide Nasal Spray
Medical subject headings
Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bencycloquidium Bromide Nasal SprayDrug

    Also called BILITING

    The content of this product is a colorless and clear liquid, press the sprayer, the liquid will be sprayed out in mist.

    This product is suitable for improving the symptoms of runny nose, nasal congestion, nasal itching and sneezing caused by allergic rhinitis.

  • Mometasone Furoate Aqueous Nasal SprayDrug

    Also called NASONEX

    Mometasone furoate nasal spray is a quantitative hand-press spray device, and the content is a white to off-white suspension.

    This product is suitable for the treatment of seasonal or perennial rhinitis in adults, adolescents and children from 3 to 11 years old. For patients who have had moderate to severe seasonal allergic rhinitis symptoms, it is recommended to use this product 2-4 weeks before the start of the pollen season Preventive treatment.

Study groups in NCT05038202
Study groupRoleWhat they receive
Bencycloquidium BromideExperimentalBencycloquidium Bromide Nasal Spray (90μg per spray)：1 spray on each nostril, 4times per day, continuous treatment for 4 weeks (28days).
Receives: Drug: Bencycloquidium Bromide Nasal Spray
Mometasone Furoate AqueousActive comparatorMometasone Furoate Aqueous Nasal Spray (50μg per spray)：2 sprays on each nostril, 1 time per day, continuous treatment for 4 weeks (28days).
Receives: Drug: Mometasone Furoate Aqueous Nasal Spray
Bencycloquidium Bromide with Mometasone Furoate AqueousExperimentalBencycloquidium Bromide Nasal Spray in combination with Mometasone Furoate Aqueous Nasal Spray: For Bencycloquidium Bromide Nasal Spray(90μg per spray), 1 spray on each nostril, 4times per day. For Mometasone Furoate Aqueous Nasal Spray (50μg per spray), 2 sprays on each nostril, 1 time per day. If there is an overlap between the two drugs, use Bencycloquidium Bromide Nasal Spray first, and then mometasone furoate nasal spray should be used after an interval of more than 30 minutes.
Receives: Drug: Bencycloquidium Bromide Nasal Spray; Drug: Mometasone Furoate Aqueous Nasal Spray

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of adverse events

    adverse clinical events that occur during drug treatment, which may not have a causal relationship with the drug.

    Measured: From the start of the enrollment to the end of the study, an average of 35days

  2. Symptom scores of runny nose

    It is the symptom scores of runny nose, based on a 4-point method:

    0 points: asymptomatic;

    1. point: mild symptoms (symptoms are mild and easy to tolerate);
    2. points: moderate symptoms (significant symptoms, annoying, but tolerable);
    3. points: Severe symptoms (symptoms cannot be tolerated, affecting daily life and/or sleep).

    Measured: immediately after the final intervention

Secondary outcomes (5)

  1. Visual Analogue Scale score of runny nose,nasal congestion, nasal itching, and sneezing

    Visual Analysis Scale (VAS, Visual Analysis Scale) score, from 0 to 10 points, the total symptoms of nasal congestion, nasal itching, and sneezing gradually increase; 0 of which is asymptomatic; 3 and below 3-the symptoms are mild and can be tolerated; 4 to 6 - the symptoms are severe but tolerable; 7 to 10 -symptoms are severe and unbearable, which affect appetite and sleep. The subjects calibrate it according to the intensity of the symptoms

    Measured: immediately after the final intervention

  2. Visual Analogue Scale score of total nasal symptoms

    24-hour retrospective review of the average change in the Visual Analogue Scale score of total nasal symptoms compared to the baseline. From 0 to 10 points, 0 of which is asymptomatic; 3 and below 3-the symptoms are mild and can be tolerated; 4 to 6 - the symptoms are severe but tolerable; 7 to 10 -symptoms are severe and unbearable, which affect appetite and sleep. The subjects calibrate it according to the intensity of the symptoms

    Measured: immediately after the final intervention

  3. Total Nasal Symptom Scores and Drug score

    Total nose symptom TNSS(Total Nasal Symptom Scores):

    It is the sum of 4 individual symptom scores of runny nose, nasal congestion, nasal itching and sneezing, totaling 12 points, and each symptom score is based on a 4-point method:

    0 points: asymptomatic;

    1. point: mild symptoms (symptoms are mild and easy to tolerate);
    2. points: moderate symptoms (significant symptoms, annoying, but tolerable);
    3. points: Severe symptoms (symptoms cannot be tolerated, affecting daily life and/or sleep).

    Drug score:

    0 points: No other drugs used to treat Allergic Rhinitis;

    1. point: Use oral antihistamines (Loratadine tablets designated in the trial, trade name: Claritin);
    2. points: use nasal hormones (not applicable for this trial);
    3. points: use oral hormones (not applicable for this trial).

    Measured: immediately after the final intervention

  4. The questionnaire of patient with global impression of change

    the subject's overall impression of symptoms change. From 0 to 4: 0 points: not evaluated;

    1. point: the symptoms are completely controlled or disappeared;
    2. points: Significant improvement in symptoms;
    3. points: the improvement of symptoms is not obvious;
    4. points: Symptoms are not improved or even worsened.

    Measured: immediately after the final intervention

  5. The questionnaire of Rhinoconjunctivitis Quality of Life

    the quality of sleep, symptoms of eyes, feelings of emotions due to the influence of nasal symptoms. From 0-6: 0-1 points: almost asymptomatic; 2-3 point: mild symptoms (symptoms are mild and easy to tolerate); 4-5 points: moderate symptoms (significant symptoms, annoying, but tolerable); 6 points: Severe symptoms

    Measured: immediately after the final intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2021
  2. Study start16 Jun 2021
  3. Primary completion30 Apr 2024 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
450 subjects with moderate-severe persistent allergic rhinitis will be enrolled in the trial and divided into three groups for different treatment.
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05038202
Sponsor's protocol ID
YG-BLT-PMS001
Status last verified
Mar 2024
First submitted
23 Aug 2021
Last updated
4 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Li X, Wang X, Yang Q, Chen J, Tian H, Lu M, Ma T, Zhang Y, Zhou Y, Xia J, Cheng L, Zhang Y, Zhang L. A Randomized Comparison of Bencycloquidium Bromide, Mometasone Furoate, and a Combination for Persistent Allergic Rhinitis. J Allergy Clin Immunol Pract. 2025 Mar;13(3):670-679.e3. doi: 10.1016/j.jaip.2024.12.035. Epub 2024 Dec 31.

    PubMed 39746515

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bencycloquidium Bromide Nasal Spray and Mometasone Furoate Aqueous Nasal Spray in people with Allergic Rhinitis, run by Yingu Pharmaceutical Co., Ltd at 6 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 4 inclusion and 11 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 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of adverse events (time frame: From the start of the enrollment to the end of the study, an average of 35days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05038202, which also lists 1 linked publication.

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 4 Mar 2024.

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