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

Administration, Intranasal Bridged Bicyclo Compounds, Heterocyclic China Double-Blind Method Humans Nasal Sprays Rhinitis, Allergic / drug therapy
Cholinergic antagonists Clinical trial, phase III Humans Nasal sprays Rhinitis, allergic

Journal

European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery
ISSN: 1434-4726
Titre abrégé: Eur Arch Otorhinolaryngol
Pays: Germany
ID NLM: 9002937

Informations de publication

Date de publication:
Nov 2020
Historique:
received: 20 03 2020
accepted: 30 06 2020
pubmed: 6 7 2020
medline: 28 4 2021
entrez: 6 7 2020
Statut: ppublish

Résumé

To investigate the efficacy and safety of bencycloquidium bromide nasal spray (BCQB) in patients with persistent allergic rhinitis (PAR). 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. 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. 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. ChiCTR2000030924, 2020/3/17.

Identifiants

DOI: 10.1007/s00405-020-06183-5 PMID: 32623510
pubmed: 32623510
doi: 10.1007/s00405-020-06183-5
pii: 10.1007/s00405-020-06183-5
doi:

Substances chimiques

Bridged Bicyclo Compounds, Heterocyclic 0
Nasal Sprays 0
bencycloquidium bromide 0

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

3067-3077

Références

Dockhorn R, Aaronson D, Bronsky E, Chervinsky P, Cohen R, Ehtessabian R, Finn A, Grossman J, Howland W, Kaiser H, Pearlman D, Sublett J, Ratner P, Settipane G, Sim T, Storms W, Webb R, Drda K, Wood C (1999) Ipratropium bromide nasal spray 0.03% and beclomethasone nasal spray alone and in combination for the treatment of rhinorrhea in perennial rhinitis. Ann Allergy Asthma Immunol 82(4):349–359. https://doi.org/10.1016/s1081-1206(10)63284-x
doi: 10.1016/s1081-1206(10)63284-x pubmed: 10227333
Lotvall J, Ekerljung L, Lundback B (2010) Multi-symptom asthma is closely related to nasal blockage, rhinorrhea and symptoms of chronic rhinosinusitis-evidence from the West Sweden Asthma Study. Respir Res 11:9. https://doi.org/10.1186/1465-9921-11-163
doi: 10.1186/1465-9921-11-163
Van Gerven L, Boeckxstaens G, Hellings PW (2012) Up-date on neuro-immune mechanisms involved in allergic and non-allergic rhinitis. Rhinology 50(3):227–235. https://doi.org/10.4193/Rhino11.152
doi: 10.4193/Rhino11.152 pubmed: 22888478
Bousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, Zuberbier T, Baena-Cagnani CE, Canonica GW, van Weel C, Agache I, Ait-Khaled N, Bachert C, Blaiss MS, Bonini S, Boulet LP, Bousquet PJ, Camargos P, Carlsen KH, Chen Y, Custovic A, Dahl R, Demoly P, Douagui H, Durham SR, van Wijk RG, Kalayci O, Kaliner MA, Kim YY, Kowalski ML, Kuna P, Le LTT, Lemiere C, Li J, Lockey RF, Mavale-Manuel S, Meltzer EO, Mohammad Y, Mullol J, Naclerio R, Hehir REO, Ohta K, Ouedraogo S, Palkonen S, Papadopoulos N, Passalacqua G, Pawankar R, Popov TA, Rabe KF, Rosado-Pinto J, Scadding GK, Simons FER, Toskala E, Valovirta E, van Cauwenberge P, Wang DY, Wickman M, Yawn BP, Yorgancioglu A, Yusuf OM, Zar H, Annesi-Maesano I, Bateman ED, Ben Kheder A, Boakye DA, Bouchard J, Burney P, Busse WW, Chan-Yeung M, Chavannes NH, Chuchalin A, Dolen WK, Emuzyte R, Grouse L, Humbert M, Jackson C, Johnston SL, Keith PK, Kemp JP, Klossek JM, Larenas-Linnemann D, Lipworth B, Malo JL, Marshall GD, Naspitz C, Nekam K, Niggemann B, Nizankowska-Mogilnicka E, Okamoto Y, Orru MP, Potter P, Price D, Stoloff SW, Vandenplas O, Viegi G, Williams D (2008) Allergic rhinitis and its impact on asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy 63:8. https://doi.org/10.1111/j.1398-9995.2007.01620.x
doi: 10.1111/j.1398-9995.2007.01620.x pubmed: 18331513
Kim KT, Kerwin E, Landwehr L, Bernstein JA, Bruner D, Harris D, Drda K, Wanger J, Wood CC (2005) Use of 0.06% ipratropium bromide nasal spray in children aged 2 to 5 years with rhinorrhea due to a common cold or allergies. Ann Allergy Asthma Immunol 94(1):73–79. https://doi.org/10.1016/s1081-1206(10)61289-6
doi: 10.1016/s1081-1206(10)61289-6 pubmed: 15702820
Meltzer EO, Orgel HA, Bronsky EA, Findlay SR, Georgitis JW, Grossman J, Ratner P, Wood CC (1992) Ipratropium bromide aqueous nasal spray for patients with perennial allergic rhinitis—a study of its effect on their symptoms, quality-of-life, and nasal cytology. Journal of Allergy and Clinical Immunology 90(2):242–249. https://doi.org/10.1016/0091-6749(92)90078-g
doi: 10.1016/0091-6749(92)90078-g pubmed: 1386857
Milgrom H, Biondi R, Georgitis JW, Meltzer EO, Munk ZM, Drda K, Wood CC (1999) Comparison of ipratropium bromide 0.03% with beclomethasone dipropionate in the treatment of perennial rhinitis in children. Ann Allergy Asthma Immunol 83(2):105–111. https://doi.org/10.1016/s1081-1206(10)62620-8
doi: 10.1016/s1081-1206(10)62620-8 pubmed: 10480582
Zhou WJ, Ding L, Wang YQ, Sun LN, Huang Y, Hu LL, Chen XP (2009) Solid phase extraction and liquid chromatography-electrospray ionization-mass spectrometry for the determination of bencycloquidium bromide in human plasma. J Chromatogr B 877(10):897–901. https://doi.org/10.1016/j.jchromb.2009.02.027
doi: 10.1016/j.jchromb.2009.02.027
Jiang JX, Cao R, Deng WD, Jin F, Dong XW, Zhu Y, Chen XP, Xie YC, Bao MJ, Li FF, Xie QM (2011) Characterization of bencycloquidium bromide, a novel muscarinic M-3 receptor antagonist in guinea pig airways. Eur J Pharmacol 655(1–3):74–82. https://doi.org/10.1016/j.ejphar.2011.01.017
doi: 10.1016/j.ejphar.2011.01.017 pubmed: 21272572
Lung MA (2011) M(1) and M(3) muscarinic receptors mediate relaxation and contraction in canine nasal veins. Am J Rhinol Allergy 25(2):E60–E65. https://doi.org/10.2500/ajra.2011.25.3604
doi: 10.2500/ajra.2011.25.3604 pubmed: 21679501
Sun L, Ding L, Wang Y, Zhou W, Yan Z, Sun W, Zhang H, Ou N, Chen X (2012) Pharmacokinetics, safety and tolerability of bencycloquidium bromide, a novel selective muscarinic M1/M3 receptor antagonist, after single and multiple intranasal doses in healthy chinese subjects: an open-label, single-center, first-in-human study. Drugs in R&D 12(1):17–28. https://doi.org/10.2165/11599330-000000000-00000
doi: 10.2165/11599330-000000000-00000
Han DM, Liu SX, Zhang Y, Wang JD, Wang DH, Kong WJ, Wang SQ, Cheng L, Zhang L, Chinese Allergic Rhinitis C (2011) Efficacy and safety of fluticasone furoate nasal spray in Chinese adult and adolescent subjects with intermittent or persistent allergic rhinitis. Allergy Asthma Proc 32(6):472–481. https://doi.org/10.2500/aap.2011.32.3474
doi: 10.2500/aap.2011.32.3474 pubmed: 21888757
Sarin S, Undem B, Sanico A, Togias A (2006) The role of the nervous system in rhinitis. J Allergy Clin Immunol 118(5):999–1014. https://doi.org/10.1016/j.jaci.2006.09.013
doi: 10.1016/j.jaci.2006.09.013 pubmed: 17088122
Bernstein JA, Singh U (2015) Neural abnormalities in nonallergic rhinitis. Curr Allergy Asthma Rep 15(4):12. https://doi.org/10.1007/s11882-015-0511-7
doi: 10.1007/s11882-015-0511-7
Cao R, Dong X-W, Jiang J-X, Yan X-F, He J-S, Deng Y-M, Li F-F, Bao M-L, Xie Y-C, Chen X-P, Xie Q-M (2011) M-3 muscarinic receptor antagonist bencycloquidium bromide attenuates allergic airway inflammation, hyperresponsiveness and remodeling in mice. Eur J Pharmacol 655(1–3):83–90. https://doi.org/10.1016/j.ejphar.2011.01.024
doi: 10.1016/j.ejphar.2011.01.024 pubmed: 21277298
Long R, Zhou YD, Huang JJ, Peng L, Meng L, Zhu SY, Li J (2015) Bencycloquidium bromide inhibits nasal hypersecretion in a rat model of allergic rhinitis. Inflamm Res 64(3–4):213–223. https://doi.org/10.1007/s00011-015-0800-6
doi: 10.1007/s00011-015-0800-6 pubmed: 25690567
Bronsky EA, Druce H, Findlay SR, Hampel FC, Kaiser H, Ratner P, Valentine MD, Wood CC (1995) A clinical-trial of ipratropium bromide nasal spray in patients with perennial nonallergic rhinitis. J Allergy Clin Immunol 95(5):1117–1122. https://doi.org/10.1016/s0091-6749(95)70215-6
doi: 10.1016/s0091-6749(95)70215-6 pubmed: 7751528
Kaiser HB, Findlay SR, Georgitis JW, Grossman J, Ratner PH, Tinkelman DG, Roszko P, Zegarelli E, Wood CC (1995) Long-term treatment of perennial allergic rhinitis with ipratropium bromide nasal spray 0.06-percent. J Allergy Clin Immunol 95(5):1128–1132. https://doi.org/10.1016/s0091-6749(95)70217-2
doi: 10.1016/s0091-6749(95)70217-2 pubmed: 7751529
Meltzer EO, Orgel HA, Biondi R, Georgitis J, Milgrom H, Munk Z, VanBavel J, Wood CC, Drda K (1997) Ipratropium nasal spray in children with perennial rhinitis. Ann Allergy Asthma Immunol 78(5):485–491. https://doi.org/10.1016/s1081-1206(10)63236-x
doi: 10.1016/s1081-1206(10)63236-x pubmed: 9164362
Georgitis JW, Banov C, Boggs PB, Dockhorn R, Grossman J, Tinkelman D, Roszko P, Wood C (1994) Ipratropium bromide nasal spray in nonallergic rhinitis - efficacy, nasal cytological response and patient-evaluation on quality-of-life. Clin Exp Allergy 24(11):1049–1055. https://doi.org/10.1111/j.1365-2222.1994.tb02742.x
doi: 10.1111/j.1365-2222.1994.tb02742.x pubmed: 7874603
Kaiser HB, Findlay SR, Georgitis JW, Grossman J, Ratner PH, Tinkelman DG, Wood CC (1998) The anticholinergic agent, ipratropium bromide, is useful in the treatment of rhinorrhea associated with perennial allergic rhinitis. Allergy Asthma Proc 19(1):23–29. https://doi.org/10.2500/108854198778557962
doi: 10.2500/108854198778557962 pubmed: 9532321
AlBalawi ZH, Othman SS, AlFaleh K (2013) Intranasal ipratropium bromide for the common cold. Cochrane Database Syst Rev 6:36. https://doi.org/10.1002/14651858.CD008231.pub3
doi: 10.1002/14651858.CD008231.pub3
Sheahan P, Thornton M, Walsh RM, Walsh MA, Costello RW (2007) Role of the muscarinic M-2 receptor in human nasal mucosa. Rhinology 45(3):229–234
pubmed: 17956025
Liu T, Xie C, Chen X, Zhao F, Liu AM, Cho DB, Chong J, Yang PC (2010) Role of muscarinic receptor activation in regulating immune cell activity in nasal mucosa. Allergy 65(8):969–977. https://doi.org/10.1111/j.1398-9995.2009.02281.x
doi: 10.1111/j.1398-9995.2009.02281.x pubmed: 19951374
Daoud A, Xie ZZ, Ma YH, Wang TS, Tan GL (2014) Changes of T-helper type 1/2 cell balance by anticholinergic treatment in allergic mice. Ann Allergy Asthma Immunol 112(3):249–255. https://doi.org/10.1016/j.anai.2013.12.014
doi: 10.1016/j.anai.2013.12.014 pubmed: 24428969
Andrews PJ, Choudhury N, Takhar A, Poirrier AL, Jacques T, Randhawa PS (2015) The need for an objective measure in septorhinoplasty surgery: are we any closer to finding an answer? Clin Otolaryngol 40(6):698–703. https://doi.org/10.1111/coa.12455
doi: 10.1111/coa.12455 pubmed: 25943502
de Oliveira GMM, Rizzo JA, Camargos PAM, Sarinho ESC (2015) Are measurements of peak nasal flow useful for evaluating nasal obstruction in patients with allergic rhinitis? Rhinology 53(2):160–166. https://doi.org/10.4193/Rhino14.048
doi: 10.4193/Rhino14.048

Auteurs

Zihan Jiang (Z)

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

Hao Xiao (H)

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

Shixi Liu (S)

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

Gang He (G)

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

Guohua Hu (G)

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

Xueyuan Zhang (X)

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

Qinna Zhang (Q)

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

Jichuan Chen (J)

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

Chang Lin (C)

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

Jianping Liang (J)

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

Mingli Guo (M)

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

Xuping Xiao (X)

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

Weiguo Xue (W)

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

Pin Dong (P)

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

Yongwang Huang (Y)

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

Zhuang Lian (Z)

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

Guolin Tan (G)

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

Jia He (J)

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

Yuanyuan Pan (Y)

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

Juan Meng (J)

Department of Otorhinolaryngology, West China Hospital, Sichuan University, 37 Guoxue Alley, Chengdu, 610041, People's Republic of China. mjmelinda@163.com.
ORCID: 0000-0002-5674-4485

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female

Evaluation of Low-Value Services Across Major Medicare Advantage Insurers and Traditional Medicare.

Ciara Duggan, Adam L Beckman, Ishani Ganguli et al.
1.00
Humans United States Aged Cross-Sectional Studies Medicare Part C

Effectiveness of Virtual Yoga for Chronic Low Back Pain: A Randomized Clinical Trial.

Hallie Tankha, Devyn Gaskins, Amanda Shallcross et al.
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH

questionsmedicales.fr › Thérapeutique › Traitement médicamenteux › Voies d'administration de substances chimiques et des médicaments › Administration par voie topique › Administration par voie muqueuse › Administration par voie nasale › Bencycloquidium bromide nasal spray is...
questionsmedicales.fr › Composés hétérocycliques › Composés hétérocycliques, cycle ponté › Composés hétérocycliques bicycliques › Bencycloquidium bromide nasal spray is...
questionsmedicales.fr › Régions géographiques › Asie › Extrême-Orient › Chine › Bencycloquidium bromide nasal spray is...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Méthode en double aveugle › Bencycloquidium bromide nasal spray is...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Bencycloquidium bromide nasal spray is...
questionsmedicales.fr › Préparations pharmaceutiques › Colloïdes › Aérosols › Pulvérisations nasales › Bencycloquidium bromide nasal spray is...
questionsmedicales.fr › Maladies du système immunitaire › Hypersensibilité › Hypersensibilité immédiate › Hypersensibilité respiratoire › Rhinite allergique › Bencycloquidium bromide nasal spray is...