Delving into the Latest Updates on Loratadine/Montelukast Sodium with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Claritin/Singulair, Loratadine/montelukast, Montelukast/loratadine

Target

CysLT1 x H1 receptor

Mechanism

CysLT1 antagonists(Cysteinyl leukotriene receptor 1 antagonists), H1 receptor antagonists(Histamine H1 receptor antagonists)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesOtorhinolaryngologic Diseases+ [1]

Active Indication-

Inactive Indication

Rhinitis, Allergic, Seasonal

Originator Organization

Merck Sharp & Dohme Corp.

Active Organization-

Inactive Organization

Merck Sharp & Dohme Corp.

Schering AG

Drug Highest PhaseDiscontinuedNDA/BLA

First Approval Date-

Regulation-

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Structure

Molecular FormulaC35H36ClNNaO3S

InChIKeyZMFQNQCXWQXCFO-HKHDRNBDSA-N

CAS Registry151767-02-1

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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.

Start Date01 Nov 2006

Sponsor / Collaborator

Organon & Co.

NCT00319995 / CompletedPhase 3

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.

Start Date01 Mar 2006

Sponsor / Collaborator

Organon & Co.

[+1]

100 Clinical Results associated with Loratadine/Montelukast Sodium

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100 Translational Medicine associated with Loratadine/Montelukast Sodium

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100 Patents (Medical) associated with Loratadine/Montelukast Sodium

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2

Literatures (Medical) associated with Loratadine/Montelukast Sodium

01 Oct 2016·Biomedicine & PharmacotherapyQ2 · MEDICINE

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

Q2 · MEDICINE

Review

Author: 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.

01 Dec 2007·Respiratory ResearchQ2 · MEDICINE

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

Q2 · MEDICINE

ArticleOA

Author: 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 Deals associated with Loratadine/Montelukast Sodium

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rhinitis, Allergic, Seasonal	NDA/BLA	-	Merck Sharp & Dohme Corp.	-
Rhinitis, Allergic, Seasonal	NDA/BLA	US	Schering AG	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01673620 (CTgov)	Phase 3	Rhinitis, Allergic	69	Montelukast 10 mg/loratadine 10 mg (Montelukast 10 mg/Loratadine 10 mg)	fgtljvvjhl(ftuylsdnyb) = ejozlmxusm odxjkcgleg (rcogadmsrx, hucrwyvlau - czczgqexwt) View more	-	14 Nov 2014
				Placebo (Placebo)	fgtljvvjhl(ftuylsdnyb) = nwwlmygodv odxjkcgleg (rcogadmsrx, aoufcmcdpn - hamyplawbw) View more