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Showing 1–24 of 36 matching trials from the live ClinicalTrials.gov search.
Local D1 index available.
Filters: Intervention: Montelukast 10Mg Tablet Clear all
Completed Phase 4 Interventional Results available

Effects of a Orally Inhaled Fluticasone Furoate on Growth Velocity in Prepubertal, Paediatric Subjects With Asthma Over a Year

NCT02889809
View directory record Official record
Conditions
Asthma
Interventions
Fluticasone furoate, Placebo, Montelukast, Short Acting Beta 2 Agonist
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
5 Years to 9 Years
Enrollment
477 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2021
U.S. locations
18
States / cities
Little Rock, Arkansas • Huntington Beach, California • Homestead, Florida + 12 more
Source: ClinicalTrials.gov public record
Updated Jan 16, 2024 · Synced Sep 26, 2026, 3:14 AM EDT
Completed Early Phase 1 Interventional Accepts healthy volunteers

Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fed Conditions

NCT01659892
View directory record Official record
Conditions
Asthma
Interventions
Montelukast, Singulair
Drug
Lead sponsor
Roxane Laboratories
Industry
Eligibility
18 Years to 45 Years
Enrollment
36 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008
U.S. locations
1
States / cities
Fargo, North Dakota
Source: ClinicalTrials.gov public record
Updated Jan 22, 2018 · Synced Sep 26, 2026, 3:14 AM EDT
Completed Not applicable Interventional Results available

Study of the Arachidonate 5-Lipoxygenase Enzyme in Affecting the Risk for Coronary Heart Disease

NCT00379808
View directory record Official record
Conditions
Coronary Heart Disease
Interventions
montelukast, Placebo
Drug
Lead sponsor
University of Florida
Other
Eligibility
18 Years and older
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2009
U.S. locations
1
States / cities
Gainesville, Florida
Source: ClinicalTrials.gov public record
Updated Jul 22, 2012 · Synced Sep 26, 2026, 3:14 AM EDT
Completed Phase 1 Interventional

Comparative Effects of Fish Oil Supplementation and a Montelukast on EIB and Airway Inflammation in Asthma

NCT00676468
View directory record Official record
Conditions
Asthma
Interventions
Active Montelukast + Fish Oil Placebo, Active Fish Oil + Montelukast Placebo, Active Montelukast + Active Fish Oil
Other
Lead sponsor
Indiana University
Other
Eligibility
18 Years to 40 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
1
States / cities
Bloomington, Indiana
Source: ClinicalTrials.gov public record
Updated Oct 8, 2009 · Synced Sep 26, 2026, 3:14 AM EDT
Completed Phase 2 Interventional Results available

Efficacy of Montelukast in Reducing the Incidence and Severity of Monoclonal Antibodies Associated Infusion Reactions

NCT04198623
View directory record Official record
Conditions
Infusion Reaction, Monoclonal Antibody
Interventions
Montelukast 10 Mg Oral Tablet
Drug
Lead sponsor
University of California, San Francisco
Other
Eligibility
18 Years and older
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2024
U.S. locations
1
States / cities
Clovis, California
Source: ClinicalTrials.gov public record
Updated Dec 14, 2025 · Synced Sep 26, 2026, 3:14 AM EDT
Completed Phase 2 Interventional Results available

Montelukast Therapy on Alzheimer's Disease

NCT03991988
View directory record Official record
Conditions
Alzheimer Disease
Interventions
Montelukast, Placebo oral tablet
Drug
Lead sponsor
Emory University
Other
Eligibility
50 Years and older
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
4
States / cities
Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Mar 6, 2024 · Synced Sep 26, 2026, 3:14 AM EDT
Completed Phase 4 Interventional Results available

A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme

NCT06019728
View directory record Official record
Conditions
Fabry's Disease
Interventions
AGALSIDASE BETA (GZ419828), Acetaminophen, Diphenhydramine, Dexamethasone, Montelukast, Loratadine, Cetirizine, Fexofenadine
Drug
Lead sponsor
Sanofi
Industry
Eligibility
2 Years to 65 Years
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
5
States / cities
Santa Monica, California • Atlanta, Georgia • Grand Rapids, Michigan + 2 more
Source: ClinicalTrials.gov public record
Updated Oct 20, 2025 · Synced Sep 26, 2026, 3:14 AM EDT
Completed Not applicable Interventional Accepts healthy volunteers

Leukotriene Antagonism in Recruitment of CD49d Expressing Neutrophils in Atopic Subjects

NCT03039101
View directory record Official record
Conditions
Nasal Allergy
Interventions
Nasal lavage, Nasal allergen challenge, Epicutaneous skin testing, Peripheral blood, Montelukast 10Mg Tablet, Placebo Oral Tablet
Procedure · Drug
Lead sponsor
Mitchell Grayson
Other
Eligibility
21 Years to 65 Years
Enrollment
25 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017 – 2018
U.S. locations
1
States / cities
Columbus, Ohio
Source: ClinicalTrials.gov public record
Updated Oct 6, 2019 · Synced Sep 26, 2026, 3:14 AM EDT
Not yet recruiting Early Phase 1 Interventional

Lipid Mediators & Cancer: Montelukast, SPM, and Almonds

NCT06887673
View directory record Official record
Conditions
Colorectal Cancer, Sarcoma, Brain Tumors, Endometrial Cancer, Ovarian Cancer
Interventions
No Interventions, Sports Pro Resolve 4 g, Double Wood SPM 4 g, 20 California Sweet Almonds, Montelukast 10 Mg Oral Tablet, Montelukast 10 Mg Oral Tablet and SPM 4 g, Cold- Pressed Almond Oil 30 mL
Other · Dietary Supplement · Drug + 1 more
Lead sponsor
University of South Florida
Other
Eligibility
18 Years and older
Enrollment
56 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
2
States / cities
Tampa, Florida
Source: ClinicalTrials.gov public record
Updated Mar 19, 2025 · Synced Sep 26, 2026, 3:14 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Evaluation of Pharmacokinetic Interaction Between GSK3640254 and Caffeine, Metoprolol, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin in Healthy Adults

NCT04425902
View directory record Official record
Conditions
HIV Infections
Interventions
GSK3640254 200 mg, Caffeine 200 mg, Metoprolol 100 mg, Montelukast 10 mg, Flurbiprofen 100 mg, Omeprazole 40 mg, Midazolam 5 mg (2.5 mL), Digoxin 0.25 mg, Pravastatin 40 mg
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years to 50 Years
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2021
U.S. locations
1
States / cities
Las Vegas, Nevada
Source: ClinicalTrials.gov public record
Updated Jan 4, 2024 · Synced Sep 26, 2026, 3:14 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Clinical Trial to Evaluate MK-4208/TERN-701 in Healthy Adult Participants (MK-4208-001/TERN701-1014)

NCT07838987
View directory record Official record
Conditions
Healthy
Interventions
TERN-701, Rabeprazole, Midazolam, Digoxin, Pravastatin, Montelukast, Omeprazole, Itraconazole, Warfarin, Rosuvastatin, Bosentan, Quinidine
Drug
Lead sponsor
Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Industry
Eligibility
18 Years to 65 Years
Enrollment
196 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023 – 2026
U.S. locations
1
States / cities
Millcreek, Utah
Source: ClinicalTrials.gov public record
Updated Sep 23, 2026 · Synced Sep 26, 2026, 3:14 AM EDT
Terminated Not applicable Interventional Results available

A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children

NCT01458418
View directory record Official record
Conditions
Eosinophilic Esophagitis
Interventions
Montelukast, placebo, 5 mg Montelukast
Drug · Other
Lead sponsor
Children's Mercy Hospital Kansas City
Other
Eligibility
2 Years to 17 Years
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2015
U.S. locations
1
States / cities
Kansas City, Missouri
Source: ClinicalTrials.gov public record
Updated Oct 29, 2020 · Synced Sep 26, 2026, 3:14 AM EDT
Completed Phase 2Phase 3 Interventional Results available

Montelukast for Early Life Wheezing

NCT00115297
View directory record Official record
Conditions
Lung Diseases, Asthma
Interventions
Montelukast, Placebo
Drug
Lead sponsor
University of Massachusetts, Worcester
Other
Eligibility
3 Months to 3 Years
Enrollment
62 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2016
U.S. locations
1
States / cities
Worcester, Massachusetts
Source: ClinicalTrials.gov public record
Updated Mar 13, 2017 · Synced Sep 26, 2026, 3:14 AM EDT
Completed Phase 4 Interventional Results available

Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens

NCT00557284
View directory record Official record
Conditions
Atopic Dermatitis
Interventions
Montelukast, Placebo
Drug
Lead sponsor
1st Allergy & Clinical Research Center
Other
Eligibility
1 Year to 8 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
2
States / cities
Centennial, Colorado • Thornton, Colorado
Source: ClinicalTrials.gov public record
Updated Apr 20, 2015 · Synced Sep 26, 2026, 3:14 AM EDT
Completed Phase 3 Interventional Results available

ACTIV-6: COVID-19 Study of Repurposed Medications - Arm F (Montelukast)

NCT05894577
View directory record Official record
Conditions
Covid19
Interventions
Placebo, Montelukast
Other · Drug
Lead sponsor
Susanna Naggie, MD
Other
Eligibility
30 Years and older
Enrollment
1,453 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
109
States / cities
Chandler, Arizona • Gilbert, Arizona • Mesa, Arizona + 96 more
Source: ClinicalTrials.gov public record
Updated Jan 16, 2025 · Synced Sep 26, 2026, 3:14 AM EDT
Recruiting Early Phase 1 Interventional

SMART 2D: Study of Montelukast's Effects on Renal and Cardiovascular Health in Adolescents and Young Adults With Type 2 Diabetes

NCT07409714
View directory record Official record
Conditions
Type 2 Diabetes
Interventions
Montelukast, Montelukast Placebo
Drug
Lead sponsor
University of Colorado, Denver
Other
Eligibility
14 Years to 24 Years
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2030
U.S. locations
1
States / cities
Aurora, Colorado
Source: ClinicalTrials.gov public record
Updated Sep 8, 2026 · Synced Sep 26, 2026, 3:14 AM EDT
Completed Early Phase 1 Interventional Accepts healthy volunteers

Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fasted Conditions

NCT01659905
View directory record Official record
Conditions
Asthma
Interventions
Montelukast, Singulair
Drug
Lead sponsor
Roxane Laboratories
Industry
Eligibility
18 Years to 45 Years
Enrollment
35 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008
U.S. locations
1
States / cities
Fargo, North Dakota
Source: ClinicalTrials.gov public record
Updated Jan 22, 2018 · Synced Sep 26, 2026, 3:14 AM EDT
Withdrawn Phase 2 Interventional

Controlled Trial on Effect of Montelukast Treatment in Children With Obstructive Sleep Apnea Syndrome

NCT00599534
View directory record Official record
Conditions
Sleep Apnea
Interventions
Montelukast, Placebo
Drug
Lead sponsor
University of Louisville
Other
Eligibility
2 Years to 9 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2009
U.S. locations
2
States / cities
Louisville, Kentucky
Source: ClinicalTrials.gov public record
Updated Apr 9, 2017 · Synced Sep 26, 2026, 3:14 AM EDT
Completed Phase 2 Interventional

Treating Exacerbations of Asthma With Oral Montelukast in Children

NCT05819541
View directory record Official record
Conditions
Status Asthmaticus
Interventions
Montelukast Oral Granules, Albuterol, Corticosteroid
Drug
Lead sponsor
Vanderbilt University Medical Center
Other
Eligibility
4 Years to 12 Years
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Jul 1, 2026 · Synced Sep 26, 2026, 3:14 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Genotype Stratified Pharmacokinetic Study of Montelukast

NCT01086527
View directory record Official record
Conditions
Asthma
Interventions
10 mg tablet of montelukast (Singulair)
Drug
Lead sponsor
Nemours Children's Clinic
Other
Eligibility
7 Years to 35 Years
Enrollment
2 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2010 – 2014
U.S. locations
1
States / cities
Jacksonville, Florida
Source: ClinicalTrials.gov public record
Updated Feb 9, 2025 · Synced Sep 26, 2026, 3:14 AM EDT
Completed Phase 3 Interventional Results available

Individualized Therapy For Asthma in Toddlers

NCT01606306
View directory record Official record
Conditions
Asthma, Wheezing
Interventions
daily fluticasone propionate, Montelukast, as-needed fluticasone propionate
Drug
Lead sponsor
Milton S. Hershey Medical Center
Other
Eligibility
12 Months to 59 Months
Enrollment
300 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
13
States / cities
Tucson, Arizona • Oakland, California • San Francisco, California + 9 more
Source: ClinicalTrials.gov public record
Updated Mar 15, 2017 · Synced Sep 26, 2026, 3:14 AM EDT
Active, not recruiting Phase 2 Interventional Results available

Premedication to Reduce Amivantamab Associated Infusion Related Reactions

NCT05663866
View directory record Official record
Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
Dexamethasone, Montelukast, Methotrexate, Amivantamab, Lazertinib
Drug
Lead sponsor
Janssen Research & Development, LLC
Industry
Eligibility
18 Years and older
Enrollment
68 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
3
States / cities
Fountain Valley, California • Fairfax, Virginia • Renton, Washington
Source: ClinicalTrials.gov public record
Updated Sep 24, 2026 · Synced Sep 26, 2026, 3:14 AM EDT
Active, not recruiting Phase 3 Interventional Accepts healthy volunteers

Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma

NCT04270409
View directory record Official record
Conditions
Plasma Cell Myeloma
Interventions
Isatuximab SAR650984, Lenalidomide, Dexamethasone, Montelukast or equivalent, Acetaminophen, Diphenhydramine or equivalent, Methylprednisolone or equivalent
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
337 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2033
U.S. locations
9
States / cities
Los Angeles, California • Denver, Colorado • Jacksonville, Florida + 6 more
Source: ClinicalTrials.gov public record
Updated Dec 11, 2025 · Synced Sep 26, 2026, 3:14 AM EDT
Completed Phase 2 Interventional

A Placebo and Active Controlled Study of ONO-6950 in Asthmatic Patients

NCT01536041
View directory record Official record
Conditions
Asthma
Interventions
ONO-6950, Montelukast, Placebo
Drug
Lead sponsor
Ono Pharma USA Inc
Industry
Eligibility
18 Years to 60 Years
Enrollment
59 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2012
U.S. locations
9
States / cities
Los Angeles, California • San Diego, California • Denver, Colorado + 6 more
Source: ClinicalTrials.gov public record
Updated Feb 13, 2014 · Synced Sep 26, 2026, 3:14 AM EDT