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Bencycloquidium bromide nasal spray is effective and safe for persistent allergic rhinitis: a phase III, multicenter, randomized, double-blinded, placebo-controlled clinical trial

  • Rhinology
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European Archives of Oto-Rhino-Laryngology Aims and scope Submit manuscript

Abstract

Purpose

To investigate the efficacy and safety of bencycloquidium bromide nasal spray (BCQB) in patients with persistent allergic rhinitis (PAR).

Methods

We enrolled 720 patients from 15 hospitals across China and randomly assigned them into BCQB group or placebo group (90 μg per nostril qid) to receive a 4-week treatment. Visual analog scale (VAS) for rhinorrhea, sneezing, nasal congestion, itching and overall symptoms were recorded by patients every day. Anterior rhinoscopy scoring was completed by doctors on every visit. Adverse events were recorded in detail.

Results

A total of 354 and 351 patients were included in BCQB group and in placebo group. Baseline information was comparable. At the end of the trial, the decrease of VAS for rhinorrhea from baseline was 4.83 ± 2.35 and 2.46 ± 2.34 in BCQB group and placebo group, respectively (P < 0.001). The change ratio from baseline of VAS for rhinorrhea in BCQB group was 72.32%, higher than 31.03% in placebo group (P < 0.001). VAS for other symptoms and overall symptoms also improved significantly in the BCQB group, while no inter-group difference was found in anterior rhinoscopy scoring. The incidence of adverse reaction was similar between the two groups. Most reactions were mild and no severe reactions happened.

Conclusion

90 μg BCQB per nostril four times daily is effective and safe in the treatment of rhinorrhea as well as sneezing, nasal congestion and itching for patients with PAR.

Retrospectively registered

ChiCTR2000030924, 2020/3/17.

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Funding

This study was funded by Yingu Pharmaceutical co., Ltd. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The authors have declared that no competing interests exist.

Author information

Author notes

    Authors and Affiliations

    1. Department of Otorhinolaryngology, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu, 610041, People’s Republic of China

      Zihan Jiang, Hao Xiao, Shixi Liu & Juan Meng

    2. Department of Otorhinolaryngology, Sichuan Provincial People’s Hospital, Chengdu, 610072, People’s Republic of China

      Gang He

    3. Department of Otolaryngology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, People’s Republic of China

      Guohua Hu

    4. Department of Otolaryngology, Southwest Hospital, Army Medical University, 30 Gaotan Yan St, Chongqing, 400038, People’s Republic of China

      Xueyuan Zhang

    5. Department of Otorhinolaryngology Head and Neck Surgery, First Hospital of Shanxi Medical University, Taiyuan, 030001, People’s Republic of China

      Qinna Zhang

    6. Department of Otorhinolaryngology, Daping Hospital, Army Medical University, Chongqing, 400042, People’s Republic of China

      Jichuan Chen

    7. Department of Otolaryngology, The First Affiliated Hospital, Fujian Medical University, Fuzhou, 350005, People’s Republic of China

      Chang Lin

    8. Department of Otolaryngology, The People’s Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, 530021, People’s Republic of China

      Jianping Liang

    9. Department of Otorhinolaryngology, Hebei General Hospital, Shijiazhuang, Hebei, 050051, People’s Republic of China

      Mingli Guo

    10. Department of Otorhinolaryngology Head and Neck Surgery, Hunan Provincial People’s Hospital, Changsha, 410005, People’s Republic of China

      Xuping Xiao

    11. Department of Otolaryngology, Qingdao Municipal Hospital, Qingdao, Shandong, 266011, People’s Republic of China

      Weiguo Xue

    12. Department of Otorhinolaryngology Head and Neck Surgery, Shanghai General Hospital, College of Medicine, Shanghai Jiao Tong University, Shanghai, 200080, People’s Republic of China

      Pin Dong

    13. Department of Otolaryngology, The Second Hospital of Tianjin Medical University, Tianjin, 300211, People’s Republic of China

      Yongwang Huang

    14. Department of Otolaryngology Head and Neck Surgery, The First People’s Hospital, Yangzhou, 225001, People’s Republic of China

      Zhuang Lian

    15. Department of Otorhinolaryngology Head and Neck Surgery, Third Xiangya Hospital, Central South University, Changsha, 410013, People’s Republic of China

      Guolin Tan

    16. Department of Health, Statistics, Faculty of Medical Service, Second Military Medical University, Shanghai, 200433, People’s Republic of China

      Jia He

    17. Yingu Pharmaceutical Co., Ltd, Beijing, 100190, People’s Republic of China

      Yuanyuan Pan

    Authors
    1. Zihan Jiang
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    2. Hao Xiao
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    3. Shixi Liu
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    4. Gang He
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    9. Chang Lin
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    18. Jia He
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    20. Juan Meng
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    Contributions

    JM was responsible for study conception, design and supervision. The manuscript was written, reviewed and edited by ZHJ and JM. Data analyses was performed by JH. Resources were provided by YYP. The other authors were responsible for material preparation and data collection at different centers. All authors read and approved the final manuscript.

    Corresponding author

    Correspondence to Juan Meng.

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    Conflict of interest

    The authors have declared that no competing interests exist.

    Ethics approval

    This study was approved by the ethics committee of all centers.

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    Participants signed an informed consent voluntarily before enrollment.

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    All co-authors agreed with the content and gave consent to submit.

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    The data are available on Resman public database.

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    Zihan Jiang, Shixi Liu, Gang He, Guohua Hu, Xueyuan Zhang, Qinna Zhang, Jichuan Chen, Chang Lin, Jianping Liang, Mingli Guo, Xuping Xiao, Weiguo Xue, Pin Dong, Yongwang Huang, Zhuang Lian, Guolin Tan and Jia He contributed equally to this work.

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    Cite this article

    Jiang, Z., Xiao, H., Liu, S. et al. Bencycloquidium bromide nasal spray is effective and safe for persistent allergic rhinitis: a phase III, multicenter, randomized, double-blinded, placebo-controlled clinical trial. Eur Arch Otorhinolaryngol 277, 3067–3077 (2020). https://doi.org/10.1007/s00405-020-06183-5

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