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

Jiang, Zihan; Hao, Xiaoyan; Liu, Shixi; He, Gang; Hu, Guohua; Zhang, Xueyuan; Zhang, Qinna; Chen, Jichuan; Lin, Cheng-Yu; Liang, Jianping; Guo, Mingli; Xiao, Xianjin; Wei-guo, Xue; Dong, Pin; Huang, Yuyu; Zhou, Lian; Tan, Guolin; He, Jia; Pan, Yuanyuan; Meng, Juan

doi:10.1007/s00405-020-06183-5

Cited by 5 publications

(6 citation statements)

References 26 publications

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“…The characteristics of all included studies are summarized in Table I 18–29 . The average study subject was male (53.73% [43.31%, 63.99%]) and 31.7 years old (range: 6–75).…”

Section: Resultsmentioning

confidence: 99%

“…The characteristics of all included studies are summarized in Table I. [18][19][20][21][22][23][24][25][26][27][28][29] The average study subject was male (53.73% [43.31%, 63.99%]) and 31.7 years old (range: 6-75). Median follow-up was 4 weeks and ipratropium bromide was the most extensively trialed anticholinergic with 10 studies.…”

Section: Study Characteristicsmentioning

confidence: 99%

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Intranasal Anticholinergics for Treatment of Chronic Rhinitis: Systematic Review and Meta‐Analysis

Pang

Vasudev

et al. 2022

The Laryngoscope

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Objective Topical intranasal anticholinergics are commonly prescribed for the relief of chronic rhinitis and associated symptoms, warranting thorough assessment of the supporting evidence. The present study aimed to evaluate the safety and efficacy of anticholinergic nasal sprays in the management of allergic and non‐allergic rhinitis symptom severity and duration. Methods A search encompassing the Cochrane Library, PubMed/MEDLINE, and Scopus databases was conducted. Primary studies describing rhinorrhea, nasal congestion, and/or postnasal drip outcomes in rhinitis patients treated with an anticholinergic spray were included for review. Results The search yielded 1,029 unique abstracts, of which 12 studies (n = 2,024) met inclusion criteria for qualitative synthesis and 9 (n = 1,920) for meta‐analysis. Median follow‐up was 4 weeks and ipratropium bromide was the most extensively trialed anticholinergic. Compared to placebo, anticholinergic treatment was demonstrated to significantly reduce rhinorrhea severity scores (standardized mean difference [95% CI] = −0.77 [−1.20, −0.35]; −0.43 [−0.72, −0.13]) and duration (−0.62 [−0.95, −0.30]; −0.29 [−0.47, −0.10]) in allergic and non‐allergic rhinitis patients respectively. Benefit was less consistent for nasal congestion, postnasal drip, and sneezing symptoms. Reported adverse effects included nasal mucosa dryness or irritation, epistaxis, headaches, and pharyngitis, though comparison to placebo found significantly greater risk for epistaxis only (risk ratio [95% CI] = 2.19 [1.22, 3.93]). Conclusion Albeit treating other symptoms with less benefit, anticholinergic nasal sprays appear to be safe and efficacious in reducing rhinorrhea severity and duration in both rhinitis etiologies. This evidence supports their continued use in the treatment of rhinitis‐associated rhinorrhea. Level of Evidence 1 Laryngoscope, 133:722–731, 2023

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“…The characteristics of all included studies are summarized in Table I 18–29 . The average study subject was male (53.73% [43.31%, 63.99%]) and 31.7 years old (range: 6–75).…”

Section: Resultsmentioning

confidence: 99%

Section: Study Characteristicsmentioning

confidence: 99%

Intranasal Anticholinergics for Treatment of Chronic Rhinitis: Systematic Review and Meta‐Analysis

Pang

Vasudev

et al. 2022

The Laryngoscope

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“…Long et al reported that the M1/M3 receptor antagonist bencycloquidium bromide could effectively treat OVAinduced AR rats, decrease nasal secretion, reduce the levels of inflammatory mediators histamine and cytokines IL-6, IL-13, and TNF-α, reverse goblet cell metaplasia, alleviate eosinophil infiltration, and inhibit mucin MUC5AC secretion (7,8). Furthermore, phase III clinical trial results of bencycloquidium bromide have confirmed its effects on AR (9). In addition, 4-DAMP was shown to effectively inhibit the IL-6 and TNF-α levels of LPS-induced lung inflammation in mice (14).…”

Section: Discussionmentioning

confidence: 99%

“…The non-selective M receptor antagonist ipratropium bromide (IB) nasal spray has been marketed as a drug to treat AR (7). Studies have found that the M1/M3 receptor antagonist bencycloquidium bromide can effectively treat AR (8,9), but there are no relevant reports on the treatment of AR with highly selective M receptor antagonists.…”

Section: Introductionmentioning

confidence: 99%

Effects of 4-DAMP on allergic rhinitis in guinea pigs and its potential mechanism

Huang¹,

Long²,

Tang³

et al. 2022

Ann Transl Med

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Background: Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E (IgE), which seriously affects the life quality of affected patients.This study aimed to observe the effects of 1,1-dimethyl-4-diphenylacetoxypiperidinium iodide (4-DAMP; a selective M3 receptor antagonist) on ovalbumin (OVA)-induced AR guinea pigs, and to explore its potential mechanism of involvement.Methods: An AR model was established by inducing male guinea pigs (4-6 weeks of age) with OVA. AR guinea pigs were randomly divided into a model group, 0.6 mg/kg ipratropium bromide (IB) group, 0.12 and 0.6 mg/kg 4-DAMP group (n=18). The 0.6 mg/kg IB group, 0.12 and 0.6 mg/kg 4-DAMP group animals were treated with IB (0.6 mg/kg) and 4-DAMP (0.12 or 0.6 mg/kg) by intranasal instillation per nostril daily.Animals in the model group and normal group were treated with saline as control. The AR symptom scores were counted and nasal secretion weights were measured. Histopathological methods were used to observe nasal mucosa. Enzyme-linked immunosorbent assay (ELISA) was used to detect the levels of histamine and cytokines. Western blot and quantitative real-time polymerase chain reaction (qRT-PCR) were used to detect the expressions of mucin 5AC (MUC5AC), matrix metalloproteinase 9 (MMP9), and epidermal growth factor receptor (EGFR).Results: Compared with model group animals, the AR symptom scores and nasal secretion weights of animals treated with 4-DAMP were reduced significantly, goblet cell metaplasia was reversed, and eosinophil infiltration was visibly alleviated. The levels of histamine and cytokines in nasal lavage fluid (NLF) were decreased, and the protein and messenger RNA (mRNA) expressions of MUC5AC, MMP9, and EGFR were inhibited.Conclusions: Treatment with 4-DAMP has a certain effect on AR, especially for mucus hypersecretion, which provides a new idea for clinical treatment of AR.

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“…The pharmacokinetics, safety and tolerability profiles of BCQB pose it as a good candidate for further development in the treatment of rhinorrhoea in rhinitis. 26 In the ChiCTR2000030924 study, BCQB nasal spray four times daily per nostril proved effective and safe in the treatment of rhinorrhoea as well as sneezing, nasal congestion and itching for patients with persistent allergic rhinitis. 27 Although an inhaled form for patients with COPD was tested in 2015 in a cigarette-exposed murine model, 28 no further studies for a lung formulation have been published.…”

Section: Bencycloquidiummentioning

confidence: 99%

<p>Long-Acting Muscarinic Antagonists Under Investigational to Treat Chronic Obstructive Pulmonary Disease</p>

Ora¹,

Coppola²,

Cazzola³

et al. 2020

JEP

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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

Cited by 5 publications

References 26 publications

Intranasal Anticholinergics for Treatment of Chronic Rhinitis: Systematic Review and Meta‐Analysis

Intranasal Anticholinergics for Treatment of Chronic Rhinitis: Systematic Review and Meta‐Analysis

Effects of 4-DAMP on allergic rhinitis in guinea pigs and its potential mechanism

<p>Long-Acting Muscarinic Antagonists Under Investigational to Treat Chronic Obstructive Pulmonary Disease</p>

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