Montelukast

Generic Name: Montelukast

Brand Names: Singulair

Drug Type: Small Molecule

Chemical Formula: C_₃₅H_₃₆ClNO_₃S

CAS Number: 158966-92-8

Unique Ingredient Identifier: MHM278SD3E

Background: Montelukast was first approved for clinical use by the US FDA in 1998 as Merck's brand name Singulair. The medication is a member of the leukotriene receptor antagonist (LTRA) category of drugs. Although capable of demonstrating effectiveness, the use of such LTRAs like montelukast is typically in addition to or complementary with the use of inhaled corticos...

Indication: Montelukast is indicated for:
...

Associated Conditions: Asthma, Exercise-Induced Bronchospasm, Perennial Allergic Rhinitis (PAR), Seasonal Allergic Rhinitis

Associated Therapies: -

Clinical Trials

Montelukast in Bronchiolitis Obliterans Syndrome

Phase 4

Completed

Conditions: Graft Rejection
Lung Transplantation
Bronchiolitis Obliterans

Interventions: Drug: Montelukast

First Posted Date: 2010-09-29

Last Posted Date: 2015-03-05

Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Target Recruit Count: 30

Registration Number: NCT01211509

Locations: 🇧🇪
UZ Gasthuisberg, Leuven, Belgium

Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age

Phase 2

Completed

Conditions: Asthma

Interventions: Drug: FP 100
Drug: GSK2190915 300
Drug: montelukast
Drug: placebo
Drug: GSK2190915 100
Drug: FP/SAL 100/50

First Posted Date: 2010-07-05

Last Posted Date: 2017-04-05

Lead Sponsor: GlaxoSmithKline

Target Recruit Count: 162

Registration Number: NCT01156792

Locations: 🇺🇸
GSK Investigational Site, Madison, Wisconsin, United States

Wheeze and Intermittent Treatment

Phase 3

Completed

Conditions: Wheezing

Interventions: Drug: Mannitol
Drug: Montelukast

First Posted Date: 2010-06-11

Last Posted Date: 2014-04-29

Lead Sponsor: Queen Mary University of London

Target Recruit Count: 1358

Registration Number: NCT01142505

Locations: 🇬🇧
Barts and the London NHS Trust, London, United Kingdom

Efficacy and Safety of add-on Montelukast to Inhaled Budesonide in the Treatment of Nonasthmatic Eosinophilic Bronchitis

Phase 4

Conditions: Nonasthmatic Eosinophilic Bronchitis

Interventions: Other: placebo to montelukast
Drug: Montelukast

First Posted Date: 2010-05-12

Last Posted Date: 2010-05-12

Lead Sponsor: Guangzhou Medical University

Target Recruit Count: 63

Registration Number: NCT01121016

Locations: 🇨🇳
Guangzhou Institute of Respiratory Disease, Guangzhou, Guangdong, China

BI 671800 in Asthmatic Patients on Inhaled Corticosteroids

Phase 2

Completed

Conditions: Asthma

Interventions: Drug: BI 671800
Drug: Placebo
Drug: Montelukast

First Posted Date: 2010-04-14

Last Posted Date: 2022-05-31

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 243

Registration Number: NCT01103349

Locations: 🇳🇿
1268.16.64003 Boehringer Ingelheim Investigational Site, Greenlane East Auckland, New Zealand
🇩🇪
1268.16.49004 Boehringer Ingelheim Investigational Site, Berlin, Germany
🇰🇷
1268.16.82009 Boehringer Ingelheim Investigational Site, Bucheon, Korea, Republic of

and more 50 locations

Effect of Montelukast Therapy in Obstructive Sleep Apnea(OSA) Children

Phase 4

Terminated

Conditions: Obstructive Sleep Apnea

Interventions: Drug: Montelukast

First Posted Date: 2009-12-09

Last Posted Date: 2019-05-03

Lead Sponsor: University of Chicago

Target Recruit Count: 64

Registration Number: NCT01027806

Locations: 🇺🇸
University of Chicago, Chicago, Illinois, United States

Moderate to Persistent Asthma in the Obese Subject

Phase 4

Terminated

Conditions: Asthma

Interventions: Other: Sugar pill
Drug: Montelukast

First Posted Date: 2009-11-20

Last Posted Date: 2014-11-17

Lead Sponsor: Duke University

Target Recruit Count: 38

Registration Number: NCT01016847

Locations: 🇺🇸
Duke Asthma Allergy and Airway Center, Durham, North Carolina, United States

Acute Montelukast in Asthma

Phase 4

Completed

Conditions: Acute Asthma Exacerbation

Interventions: Drug: Placebo
Drug: Montelukast

First Posted Date: 2009-11-11

Last Posted Date: 2009-11-11

Lead Sponsor: University of East Anglia

Target Recruit Count: 87

Registration Number: NCT01011452

Locations: 🇬🇧
Norfolk and Norwich University Hospital, Norwich, United Kingdom

Sputum Matrix Metalloproteinases (MMP) mRNA and Montelukast

Phase 2

Completed

Conditions: Asthma

Interventions: Drug: montelukast

First Posted Date: 2009-07-28

Last Posted Date: 2012-08-23

Lead Sponsor: University of East Anglia

Target Recruit Count: 15

Registration Number: NCT00947453

Locations: 🇬🇧
University of East Anglia, Norwich, Norfolk, United Kingdom

Dose Finding Trial to Assess the Efficacy and Safety of SOTB07 in Persistent Asthma

Phase 2

Completed

Conditions: Asthma

Interventions: Drug: SOTB07
Drug: placebo
Drug: montelukast

First Posted Date: 2009-07-10

Last Posted Date: 2013-12-19

Lead Sponsor: SK Chemicals Co., Ltd.

Target Recruit Count: 245

Registration Number: NCT00936624

Locations: 🇰🇷
Seoul National University Hospital, Seoul, Korea, Republic of

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