BNO-1016(BNO-1016) - _专利_临床

概要

基本信息

药物类型

中药

别名

sinupret extract mite

靶点-

作用机制-

治疗领域

免疫系统疾病感染耳鼻咽喉疾病+ [1]

在研适应症-

非在研适应症

慢性鼻窦炎过敏性鼻炎

原研机构

Bionorica SE

在研机构-

非在研机构

Bionorica SE

最高研发阶段无进展临床3期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 BNO-1016 相关的临床试验

NCT01706484 / Completed临床3期

A Multicentre, Randomised, Double-blind, Placebo-controlled, Parallel Group Trial to Assess Efficacy and Safety of Two Dosages of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Chronic Rhinosinusitis

The purpose of this trial is to determine whether 2 different dosages of a herbal extract (240 and 480 mg/day) are more effective than placebo in the treatment of patients with chronic rhinosinusitis (average reduction of investigator's Major Symptom Score over Visit 5 and Visit 6.

开始日期2012-09-01

申办/合作机构

Bionorica SE

NCT01146860 / Completed临床3期

A Multi-centre, Double-blind, Placebo-controlled, Randomised, Parallel Group Study to Assess the Efficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute Rhinosinusitis

The purpose of this study is to determine whether the dry extract BNO 1016 is effective and safe in the treatment of acute rhinosinusitis in adults.

开始日期2010-01-01

申办/合作机构

Bionorica SE

100 项与 BNO-1016 相关的临床结果

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100 项与 BNO-1016 相关的转化医学

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100 项与 BNO-1016 相关的专利（医药）

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9

项与 BNO-1016 相关的文献（医药）

2023-09-13·Otolaryngologia Polska

Microbiota and antibiotic therapy in rhinosinusitis

Article

作者: Zawadzka - Głos, Lidia

Rhinosinusitis is one of the most frequently diagnosed diseases in patients seeking medical consultation. Sinusitis is a heterogeneous group of diseases and can be acute or chronic.The current state of knowledge on rhinosinusitis is presented in the recommendations of the European Position Paper on Rhinosynusitis and Nasal Polyps 2020 (EPOS 2020). More and more attention is paid to the condition of the microbiota in the context of inflammatory changes in the sinuses.There is also a negative effect of excessively prescribed antibiotics on the increase in bacterial resistance to drugs and significant changes in the disturbance in the composition of the microbiota during antibiotic therapy. Since the most common etiology of acute sinusitis is viral, the use of antibiotics in uncomplicated sinusitis is unjustified. New therapeutic solutions are sought, including the use of herbal medicines. The EPOS 2020 document recommends the use of BNO1016 in uncomplicated acute rhinosinusitis. New models of treatment also take into account the use of biological drugs, especially in the treatment of chronic rhinosinusitis.

2023-08-01·Postgraduate medicine

Efficacy and effectiveness of the herbal medicinal product BNO 1016 in the management of acute rhinosinusitis in the context of antibiotic stewardship.

Article

作者: Abels, Christoph ; Plach, Michael ; Abramov-Sommariva, Dimitri ; Bittner, Claudia B ; Bachert, Claus ; Steindl, Hubert

OBJECTIVESTo substantiate the clinical efficacy and investigate the real-world effectiveness of the herbal medicinal product BNO 1016 in acute rhinosinusitis (ARS) in the context of antibiotic stewardship.METHODSWe performed a meta-analysis of the clinical trials ARhiSi-1 (EudraCT No. 2008-002794-13) and ARhiSi-2 (EudraCT No. 2009-016682-28) comprising 676 patients, analyzing the reduction of the Major Symptom Score (MSS) and improvement of the Sino-Nasal Outcome Test 20 (SNOT-20) by the herbal medicinal product BNO 1016. In addition, we performed a retrospective cohort study including 203,382 patients, comparing the real-life effectiveness of BNO 1016 in reducing ARS-related adverse outcomes in comparison to antibiotics and several other established therapies.RESULTSTreatment with BNO 1016 ameliorated symptoms of ARS by reducing MSS by 1.9 points (p < 0.0001) and improved quality of life (QoL) for patients by improving SNOT-20 by 3.5 points (p = 0.001) in comparison to placebo. In patients with moderate/severe symptoms, the positive effects of BNO 1016 were even more pronounced (MSS: -2.3 points (p < 0.0001); SNOT-20: -4.9 points (p = 0.0158)). In addition, treatment with BNO 1016 was as effective or significantly more effective in reducing the risk for adverse ARS-related outcomes such as follow-up antibiotic prescriptions, sick leave ≥7 days or medical appointments due to ARS, especially when compared to antibiotics.CONCLUSIONBNO 1016 is a safe and effective treatment for ARS that can help reduce the overuse of antibiotics.

2023-02-01·Planta Medica3区 · 医学

Food Interactions Observed in a Pharmacokinetic Investigation Comparing Two Marketed Cold Preparations (BNO1016 and ELOM-080) after Administration to Beagle Dogs – A Pilot Study

3区 · 医学

Article

作者: Neumann, Astrid ; Müller, Anne ; Wonnemann, Meinolf ; Seibel, Jan

AbstractSinupret extract (BNO 1016) and Gelomyrtol forte (ELOM-080) represent the two top-selling cold remedies in Germany nowadays. Whereas BNO 1016 is a typical immediate release coated tablet, ELOM-080 is an enteric-coated soft gelatin capsule. The latter formulation, however, is at risk of pharmacokinetic interactions affecting absorption, especially in cases of concomitant food intake. In the present pilot study, we investigated the risk of a possible food effect in three male beagle dogs. Single doses of BNO 1016 and ELOM-80 were administered under fasting and fed conditions. Blood was sampled up to 30 h post-administration and plasma concentrations of the characteristic ingredients of BNO 1016 as well as ELOM-080 analytes were determined. Pharmacokinetic parameters focusing on the rate and extent of absorption were derived. BNO 1016 analytes demonstrated a similar course in both the fasted and fed states. ELOM-080 analytes also showed a similar picture in the fasted state. However, lag times (time from administration to first quantifiable time point in plasma) of up to 2 h post-administration with corresponding time to reach maximum concentration (obtained directly from the measured concentration) values of 3 to 4 h were observed, reflecting a longer gastric residence time. In the fed state, ELOM-080 showed significant pharmacokinetic characteristics, suggesting a clear food effect. A major observation was a double peak phenomenon that could be observed in two of three dogs. Furthermore, lag times of some analytes, up to 3 – 4 h, and corresponding time to reach maximum concentration values, up to 6 – 8 h, occurred. In contrast to BNO 1016, these findings suggest that, as with other enteric-coated formulations, there may also be a significant risk for food effects with ELOM-080 in humans.

100 项与 BNO-1016 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
慢性鼻窦炎	临床3期	比利时	Bionorica SE	2012-09-01
过敏性鼻炎	临床3期	德国	Bionorica SE	2010-01-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01146860 (CTgov)	临床3期	过敏性鼻炎	386	BNO 1016 (BNO 1016)	夢鹽鹽齋衊觸壓膚鏇網(獵蓋繭願遞製淵壓積築) = 鑰膚蓋觸網膚艱襯廠淵衊憲醖網願衊繭顧糧鹹 (鏇醖觸廠廠膚鏇鑰餘獵, 憲鑰願鏇鏇膚鹽遞繭製 ~ 獵醖廠壓簾範鹽壓範餘) 更多	-	2013-08-02
				Placebo (Placebo)	夢鹽鹽齋衊觸壓膚鏇網(獵蓋繭願遞製淵壓積築) = 蓋構鏇蓋繭繭網餘膚網衊憲醖網願衊繭顧糧鹹 (鏇醖觸廠廠膚鏇鑰餘獵, 窪齋夢壓糧觸襯壓觸蓋 ~ 窪簾獵淵鏇製鑰範鹽積) 更多