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Showing 1–24 of 42 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Montelukast 10 mg Clear all
Not listed Phase 2Phase 3 Interventional

Montelukast With Status Asthmaticus, Ages 6-18

NCT00494572
View directory record Official record
Conditions
Status Asthmaticus, Asthma
Interventions
Montelukast, sterile water
Drug · Other
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Eligibility
6 Years to 18 Years
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2010
U.S. locations
1
States / cities
Cleveland, Ohio
Source: ClinicalTrials.gov public record
Updated Dec 15, 2008 · Synced Sep 25, 2026, 10:24 AM EDT
Completed Phase 2 Interventional

Dose Finding Study for QAW039 in Asthma

NCT01437735
View directory record Official record
Conditions
Asthma
Interventions
QAW039, Montelukast, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 65 Years
Enrollment
1,043 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
38
States / cities
Scottsdale, Arizona • Encinitas, California • Huntington Beach, California + 33 more
Source: ClinicalTrials.gov public record
Updated Dec 18, 2020 · Synced Sep 25, 2026, 10:24 AM EDT
Withdrawn Phase 3 Interventional Accepts healthy volunteers

Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

NCT01702701
View directory record Official record
Conditions
Eosinophilic Esophagitis, Dysphagia
Interventions
Montelukast, Fluticasone
Drug
Lead sponsor
Medical College of Wisconsin
Other
Eligibility
18 Years and older
Healthy volunteers
Accepts healthy volunteers
Timeline
2012 – 2017
U.S. locations
2
States / cities
Milwaukee, Wisconsin
Source: ClinicalTrials.gov public record
Updated Aug 27, 2019 · Synced Sep 25, 2026, 10:24 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 25, 2026, 10:24 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 25, 2026, 10:24 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 25, 2026, 10:24 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 25, 2026, 10:24 AM EDT
Completed Not applicable Interventional

Transporter Mediated Uptake of Montelukast

NCT00513760
View directory record Official record
Conditions
Asthma
Interventions
Grapefruit juice, Orange Juice, Gatorade
Dietary Supplement
Lead sponsor
Nemours Children's Clinic
Other
Eligibility
15 Years to 18 Years
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2014
U.S. locations
1
States / cities
Jacksonville, Florida
Source: ClinicalTrials.gov public record
Updated Feb 9, 2025 · Synced Sep 25, 2026, 10:24 AM EDT
Recruiting Phase 2 Interventional

Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma

NCT05896228
View directory record Official record
Conditions
Refractory Multiple Myeloma, Relapsed Multiple Myeloma
Interventions
Iberdomide, Carfilzomib, Daratumumab, Dexamethasone, Acetaminophen, Diphenhydramine, Montelukast
Drug
Lead sponsor
Benjamin T Diamond, MD
Other
Eligibility
18 Years to 75 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2031
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Mar 10, 2026 · Synced Sep 25, 2026, 10:24 AM EDT
Completed Phase 4 Interventional

Asthma in the Elderly: The Effect of Montelukast

NCT02635334
View directory record Official record
Conditions
Asthma
Interventions
Montelukast 10 mg orally, Placebo
Drug · Other
Lead sponsor
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
Other
Eligibility
65 Years and older
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
1
States / cities
Bryn Mawr, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Oct 4, 2016 · Synced Sep 25, 2026, 10:24 AM EDT
Completed Phase 4 Interventional Accepts healthy volunteers Results available

CYP2B6 Genetics and Drug Interactions in Healthy Volunteers

NCT02401256
View directory record Official record
Conditions
Healthy
Interventions
Efavirenz, Bupropion, Rosuvastatin, Montelukast
Drug
Lead sponsor
Indiana University
Other
Eligibility
18 Years to 49 Years
Enrollment
70 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013 – 2016
U.S. locations
1
States / cities
Indianapolis, Indiana
Source: ClinicalTrials.gov public record
Updated Oct 10, 2017 · Synced Sep 25, 2026, 10:24 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 25, 2026, 10:24 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 25, 2026, 10:24 AM EDT
Completed Not applicable Interventional Results available

Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma

NCT00359073
View directory record Official record
Conditions
Asthma
Interventions
montelukast, placebo
Drug
Lead sponsor
University of Wisconsin, Madison
Other
Eligibility
18 Years to 65 Years
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2009
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Mar 12, 2018 · Synced Sep 25, 2026, 10:24 AM EDT
Terminated Phase 4 Interventional Results available

Moderate to Persistent Asthma in the Obese Subject

NCT01016847
View directory record Official record
Conditions
Asthma
Interventions
Montelukast, Sugar pill
Drug · Other
Lead sponsor
Duke University
Other
Eligibility
18 Years to 65 Years
Enrollment
38 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2013
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Nov 16, 2014 · Synced Sep 25, 2026, 10:24 AM EDT
Completed Not applicable Interventional Accepts healthy volunteers

Airborne Ultrafine and Fine Particulate Matter: A Cause for Endothelial Dysfunction in Man?

NCT00814281
View directory record Official record
Conditions
Airway Inflammation
Interventions
placebo, Montelukast
Other · Drug
Lead sponsor
Marywood University
Other
Eligibility
18 Years to 30 Years · Male only
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2007 – 2009
U.S. locations
1
States / cities
Scranton, Pennsylvania
Source: ClinicalTrials.gov public record
Updated May 20, 2009 · Synced Sep 25, 2026, 10:24 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 25, 2026, 10:24 AM EDT
Recruiting Early Phase 1 Interventional

MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)

NCT04572256
View directory record Official record
Conditions
ACL Injury, Meniscus Tear, Post-traumatic Osteoarthritis
Interventions
Montelukast, Placebo
Drug
Lead sponsor
Austin V Stone
Other
Eligibility
25 Years to 50 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
1
States / cities
Lexington, Kentucky
Source: ClinicalTrials.gov public record
Updated Jun 9, 2026 · Synced Sep 25, 2026, 10:24 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 25, 2026, 10:24 AM EDT
Active, not recruiting Phase 2 Interventional

A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma

NCT04268498
View directory record Official record
Conditions
Multiple Myeloma
Interventions
Bortezomib, Dexamethasone, Lenalidomide, Acetaminophen, Diphenhydramine, Montelukast, Carfilzomib, Daratumumab, Autologous Stem Cell Transplant (ASCT)
Drug · Biological
Lead sponsor
University of Miami
Other
Eligibility
18 Years to 75 Years
Enrollment
310 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2027
U.S. locations
7
States / cities
Miami, Florida • Tampa, Florida • Buffalo, New York + 4 more
Source: ClinicalTrials.gov public record
Updated Mar 23, 2026 · Synced Sep 25, 2026, 10:24 AM EDT
Completed Phase 4 Interventional

Exercise Induced Bronchospasm in Children

NCT00273689
View directory record Official record
Conditions
Exercise Induced Bronchospasm
Interventions
montelukast vs pretreatment with albuterol, montelukast
Drug
Lead sponsor
University of New Mexico
Other
Eligibility
7 Years to 17 Years
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2007
U.S. locations
1
States / cities
Albuquerque, New Mexico
Source: ClinicalTrials.gov public record
Updated May 6, 2008 · Synced Sep 25, 2026, 10:24 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 25, 2026, 10:24 AM EDT
Terminated Phase 4 Interventional Accepts healthy volunteers Results available

The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis

NCT00119015
View directory record Official record
Conditions
Rhinitis, Allergic, Perennial
Interventions
Placebo, Montelukast, Fluticasone propionate
Drug
Lead sponsor
University of Chicago
Other
Eligibility
18 Years to 55 Years
Enrollment
102 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2005 – 2009
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Feb 27, 2014 · Synced Sep 25, 2026, 10:24 AM EDT
Active, not recruiting Phase 4 Interventional

Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere's Disease

NCT04815187
View directory record Official record
Conditions
Meniere Disease, Allergic Rhinitis, Vertigo
Interventions
Montelukast, Placebo
Drug
Lead sponsor
House Ear Institute
Other
Eligibility
18 Years and older
Enrollment
39 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
2
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Mar 17, 2025 · Synced Sep 25, 2026, 10:24 AM EDT