氯雷他定/孟鲁司特钠(Loratadine/Montelukast Sodium) - 药物靶点：CysLT1 x H1 receptor_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Claritin/Singulair、Loratadine/montelukast、Montelukast/loratadine

靶点

CysLT1 x H1 receptor

作用机制

CysLT1拮抗剂(半胱氨酰白三烯受体-1拮抗剂)、H1 receptor拮抗剂(组胺H1受体拮抗剂)

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

季节性过敏性鼻炎

原研机构

Merck Sharp & Dohme Corp.

在研机构-

非在研机构

Merck Sharp & Dohme Corp.

Schering AG

最高研发阶段终止申请上市

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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结构

分子式C35H36ClNNaO3S

InChIKeyZMFQNQCXWQXCFO-HKHDRNBDSA-N

CAS号151767-02-1

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关联

5

项与氯雷他定/孟鲁司特钠相关的临床试验

NCT01673620 / Completed临床3期

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety of Combination Montelukast/Loratadine (MK-0476A) in Mexican Patients With Allergic Rhinitis

The purpose of this study is to assess the safety and tolerability of montelukast 10 mg/loratadine 10 mg versus placebo in Mexican participants with allergic rhinitis.

开始日期2012-07-04

申办/合作机构

Organon & Co.

NCT00423995 / Completed临床3期

Study of the Decongestant Effect of the Combination of Loratadine and Montelukast Compared With Placebo in SAR Subjects Exposed to Pollen in an Environmental Exposure Unit

This is study of LMC, phenylephrine, and placebo in subjects with SAR. There are three visits: At Visit 1, subjects will be evaluated for participation and, if they qualify, will attend Visit 2 for priming. At Visit 2, ragweed pollen will be fed continuously and dispensed into the environmental exposure unit to induce an allergic reaction. Pollen counts will be monitored and recorded. During the priming visit(s), subjects will be evaluated to determine if they qualify. If qualified, they will return for Visit 3, where ragweed pollen will be fed continuously and dispensed into the environmental exposure unit to induce an allergic reaction. Pollen counts will be monitored and recorded as in the Priming Session. Subjects will complete symptom evaluations and if qualified, they will receive study medication and remain in the environmental exposure unit where symptoms will be evaluated for 8 hours after dosing. PNIF will be evaluated only during the treatment session. Four nasal symptoms (rhinorrhea, nasal congestion, sneezing, and nasal itching) and three non-nasal symptoms (itching/burning eyes, tearing/watery eyes, and itching of ears/palate) will be evaluated. Adverse events will be collected throughout the study to assess safety and tolerability, and vital signs will be collected at Visit 1 and at the end of Visit 3.

开始日期2006-11-01

申办/合作机构

Organon & Co.

NCT00319995 / Completed临床3期

Efficacy and Safety of Combination Loratadine/Montelukast QD vs Pseudoephedrine and Placebo in the Treatment of Subjects With Seasonal Allergic Rhinitis

This is a Phase 3, randomized, parallel-group, multicenter, double-dummy, double-blind study with a screening period. Subjects will receive one of the following three treatment groups for 15 days: loratadine 10 mg/montelukast 10 mg combination, pseudoephedrine 240 mg, or placebo. The primary objective of this study is to assess the efficacy of the combination of loratadine/montelukast, a once-daily tablet containing 10 mg loratadine and 10 mg montelukast, compared with placebo in subjects with seasonal allergic rhinitis (SAR) in relieving the symptom of nasal congestion. The safety profile of combined loratadine/montelukast relative to placebo and pseudoephedrine will also be evaluated.

开始日期2006-03-01

申办/合作机构

Organon & Co.

[+1]

100 项与氯雷他定/孟鲁司特钠相关的临床结果

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100 项与氯雷他定/孟鲁司特钠相关的转化医学

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100 项与氯雷他定/孟鲁司特钠相关的专利（医药）

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2

项与氯雷他定/孟鲁司特钠相关的文献（医药）

2016-10-01·Biomedicine & Pharmacotherapy2区 · 医学

The efficacy and safety of H1-antihistamine versus Montelukast for allergic rhinitis: A systematic review and meta-analysis

2区 · 医学

Review

作者: Wei, Chunhui

PURPOSEIn order to verify the differences of effectiveness and safety between SAHs and Montelukast, and to find out potential uncared-for problems, we performed a systematic review and Meta-analysis to proceed a qualitative describe and quantitative assessment.METHODSWe searched the databases of Pubmed, the Cochrane Library, Nature and Science as well as Wanfang data and CNKI from 2000 to March 2016, using key words "Montelukast SAH" or "H1-antihistamine Montelukast", or "Loratadine Montelukast", or "Desloratadine Montelukast", or "Levocetirizine Montelukast", or "Cetirizen Montelukast", or "Fexofenadine Montelukast". And also we included studies through relevant citations in related literature. Meta-analysis and bias of risk were performed. We analyzed Heterogeneity and publish bias as well.RESULTMontelukast seems more effective in nighttime symptoms compare with SAHs (P=0.008, MD=-0.04, 95%CI: -0.08, -0.01). No significant difference was found between Montelukast and SAHs in CSS (P=0.10, MD=0.03, 95%CI: -0.01, 0.07). Montelukast and SAHs combined therapy was more effective than Montelukast DNSS (P=0.0006, MD=0.15, 95%CI: 0.07, 0.24) but not in CSS (P=0.04, MD=0.08, 95%CI: 0.00, 0.15; Bonferroni correction α=0.017).CONCLUSIONMontelukast has a significant influence in improving patients' nasal symptoms quality of live but is not as effective as SAHs, and may have a slight advantage over SAHs in relieving nighttime symptoms significantly. Combined therapy is more effective in improving patients' day time symptom than Montelukast. Probably, patients might have a lower asthenia incidence rate when using Montelukas.

2007-12-01·Respiratory Research2区 · 医学

Salmeterol plus fluticasone propionate versus fluticasone propionate plus montelukast: a randomised controlled trial investigating the effects on airway inflammation in asthma

2区 · 医学

ArticleOA

作者: Ashley Woodcock ; Debbie Parker ; Leanne Rice ; Ian Pavord

BACKGROUNDFew studies have compared treatment strategies in patients with asthma poorly controlled on low dose inhaled corticosteroids, and little is known about the effects of different treatments on airway inflammation. In this double-blind, placebo-controlled, parallel group study, we compared the effects of salmeterol plus fluticasone propionate (FP) (Seretide; SFC) and FP plus montelukast (FP/M) on sputum inflammatory markers, airway responsiveness, lung function, and symptoms in adult asthmatics.METHODSSixty-six subjects were randomised to SFC or FP/M for 12 weeks. The primary outcome was changes in neutrophil, eosinophil, macrophage, lymphocyte, and epithelial cell levels in induced sputum. Additional outcomes included the change in other sputum markers of airway inflammation, airway responsiveness, symptom control, and lung function.RESULTSBoth treatments had no significant effect on induced sputum inflammatory cells, although there was a trend for a reduction in sputum eosinophils. Both treatments significantly improved airway responsiveness, whereas SFC generally led to greater improvements in symptom control and lung function than FP/M. FP/M led to significantly greater reductions in sputum cysteinyl leukotrienes than SFC (treatment ratio 1.80; 95% CI 1.09, 2.94).CONCLUSIONBoth treatments led to similar control of eosinophilic airway inflammation, although PEF and symptom control were better with SFC. STUDY NUMBER: SAM40030 (SOLTA).

100 项与氯雷他定/孟鲁司特钠相关的药物交易

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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
季节性过敏性鼻炎	申请上市	-	Merck Sharp & Dohme Corp.	-
季节性过敏性鼻炎	申请上市	美国	Schering AG	-

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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


NCT01673620 (CTgov)	临床3期	过敏性鼻炎	69	Montelukast 10 mg/loratadine 10 mg (Montelukast 10 mg/Loratadine 10 mg)	壓夢顧憲鏇蓋鹹壓選鏇(網網鏇糧簾簾繭衊醖餘) = 願蓋襯餘鹹壓鑰製鹹醖鬱獵繭餘膚鏇醖遞鹹願 (夢鹽夢襯衊獵糧夢壓鏇, 襯窪膚觸襯簾願遞製艱 ~ 繭餘製簾廠蓋積壓鑰製) 更多	-	2014-11-14
				Placebo (Placebo)	壓夢顧憲鏇蓋鹹壓選鏇(網網鏇糧簾簾繭衊醖餘) = 衊繭憲衊襯範鹽窪鹽願鬱獵繭餘膚鏇醖遞鹹願 (夢鹽夢襯衊獵糧夢壓鏇, 網選鏇鬱壓鹹鬱壓願繭 ~ 衊壓鹹鑰鹹夢構壓鹽膚) 更多