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Showing 1–24 of 25 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: 5 mg Montelukast Clear all
Not listed Phase 2Phase 3 Interventional

Montelukast With Status Asthmaticus, Ages 2-5

NCT00491790
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
2 Years to 5 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, 6:02 AM EDT
Terminated Phase 1Phase 2 Interventional Results available

Sym013 (Pan-HER) in Patients With Advanced Epithelial Malignancies

NCT02906670
View directory record Official record
Conditions
Oncology
Interventions
Sym013
Drug
Lead sponsor
Symphogen A/S
Industry
Eligibility
18 Years and older
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
3
States / cities
Nashville, Tennessee • San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Aug 27, 2020 · Synced Sep 25, 2026, 6:02 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 25, 2026, 6:02 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, 6:02 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, 6:02 AM EDT
Completed Phase 3 Interventional Results available

ACTIV-6: COVID-19 Study of Repurposed Medications

NCT04885530
View directory record Official record
Conditions
Covid19
Interventions
Ivermectin, Fluvoxamine, Fluticasone, Placebo, Montelukast, Metformin
Drug · Other
Lead sponsor
Susanna Naggie, MD
Other
Eligibility
30 Years and older
Enrollment
10,956 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
110
States / cities
Chandler, Arizona • Gilbert, Arizona • Mesa, Arizona + 96 more
Source: ClinicalTrials.gov public record
Updated Nov 16, 2025 · Synced Sep 25, 2026, 6:02 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 25, 2026, 6:02 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 25, 2026, 6:02 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 25, 2026, 6:02 AM EDT
Terminated Not applicable Interventional

Montelukast Added to Standard Therapy for Acute Asthma in Children Age 6-14 Years

NCT00353184
View directory record Official record
Conditions
Asthma
Interventions
Montelukast 5-mg orally added to standard therapy
Drug
Lead sponsor
Washington University School of Medicine
Other
Eligibility
6 Years to 14 Years
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2005
U.S. locations
1
States / cities
St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Feb 23, 2010 · Synced Sep 25, 2026, 6:02 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 25, 2026, 6:02 AM EDT
Completed Phase 2 Interventional Results available

Montelukast to Treat Bronchiolitis Obliterans

NCT00656058
View directory record Official record
Conditions
Bronchiolitis Obliterans, Chronic Graft Versus Host Disease, Leukotriene, Montelukast, Stem Cell Transplant
Interventions
Singulair (Montelukast Sodium)
Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
6 Years to 80 Years
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2018
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Apr 8, 2018 · Synced Sep 25, 2026, 6:02 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, 6:02 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, 6:02 AM EDT
Completed Phase 3 Interventional Results available

Childhood Asthma Research and Education (CARE) Network Trial - Best Add-On Therapy Giving Effective Response (BADGER)

NCT00395304
View directory record Official record
Conditions
Asthma
Interventions
fluticasone propionate + montelukast, fluticasone propionate, fluticasone propionate + salmeterol
Drug
Lead sponsor
Milton S. Hershey Medical Center
Other
Eligibility
6 Years to 18 Years
Enrollment
182 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2011
U.S. locations
5
States / cities
Tucson, Arizona • San Diego, California • Denver, Colorado + 2 more
Source: ClinicalTrials.gov public record
Updated Jul 1, 2018 · Synced Sep 25, 2026, 6:02 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, 6:02 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 25, 2026, 6:02 AM EDT
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 25, 2026, 6:02 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 25, 2026, 6:02 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, 6:02 AM EDT
Completed Phase 4 Interventional Results available

The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial

NCT00156819
View directory record Official record
Conditions
Asthma
Interventions
fluticasone, montelukast, Fluticasone plus salmeterol
Drug
Lead sponsor
JHSPH Center for Clinical Trials
Other
Eligibility
6 Years and older
Enrollment
500 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2006
U.S. locations
19
States / cities
Birmingham, Alabama • Denver, Colorado • Jacksonville, Florida + 16 more
Source: ClinicalTrials.gov public record
Updated Dec 8, 2015 · Synced Sep 25, 2026, 6:02 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, 6:02 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, 6:02 AM EDT
Completed Phase 3 Interventional Results available

Effect of Fluticasone Furoate Inhalation Powder on the Hypothalamic-pituitary-adrenocortical Axis of Children Aged 5-11 Years With Asthma

NCT02483975
View directory record Official record
Conditions
Asthma
Interventions
FF, Placebo, Montelukast, Albuterol/Salbutamol
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
5 Years to 11 Years
Enrollment
111 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
14
States / cities
Little Rock, Arkansas • Alhambra, California • Costa Mesa, California + 8 more
Source: ClinicalTrials.gov public record
Updated Apr 26, 2020 · Synced Sep 25, 2026, 6:02 AM EDT