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ClinicalTrials.gov public records Last synced Oct 1, 2026, 6:16 AM EDT

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Showing 49–72 of 108 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Montelukast Clear all
Completed Phase 1 Interventional

Ventilatory Heterogeneity in Participants With Asthma (MK-0476-513)

NCT01621386
View directory record Official record
Conditions
Asthma
Interventions
Montelukast, Prednisone
Drug
Lead sponsor
Hal C Charles
Other
Eligibility
18 Years to 65 Years
Enrollment
34 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2016
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Apr 20, 2017 · Synced Oct 1, 2026, 6:16 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 5, 2024 · Synced Oct 1, 2026, 6:16 AM EDT
Not listed Phase 4 Interventional

Singulair Use in Non-Allergic Rhinitis Eosinophil Syndrome (NARES)

NCT00406094
View directory record Official record
Conditions
Rhinitis
Interventions
montelukast, placebo
Drug
Lead sponsor
Bernstein, Jonathan A., M.D.
Individual
Eligibility
18 Years to 65 Years
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2009
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Jan 16, 2009 · Synced Oct 1, 2026, 6:16 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 28, 2020 · Synced Oct 1, 2026, 6:16 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 21, 2009 · Synced Oct 1, 2026, 6:16 AM EDT
Completed Phase 4 Interventional

Study Of Patients With Allergic Rhinitis And Asthma

NCT00296530
View directory record Official record
Conditions
Asthma
Interventions
fluticasone propionate/salmeterol, fluticasone propionate, montelukast
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
15 Years and older
Enrollment
600 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2007
U.S. locations
80
States / cities
Ozark, Alabama • Tempe, Arizona • Little Rock, Arkansas + 67 more
Source: ClinicalTrials.gov public record
Updated Oct 28, 2016 · Synced Oct 1, 2026, 6:16 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 17, 2025 · Synced Oct 1, 2026, 6:16 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 14, 2014 · Synced Oct 1, 2026, 6:16 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 2, 2018 · Synced Oct 1, 2026, 6:16 AM EDT
Recruiting Phase 4 Interventional

Evaluating Premedication Regimens (Methylprednisolone vs Dexamethasone-based) for the Prevention of Systemic and Injection Site Reactions to Motixafortide in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization, PARADE Trial

NCT07101445
View directory record Official record
Conditions
Multiple Myeloma
Interventions
Acetaminophen, Biospecimen Collection, Dexamethasone, Electronic Health Record Review, Famotidine, Loratadine, Methylprednisolone, Montelukast, Motixafortide, Pheresis, Questionnaire Administration, Recombinant Granulocyte Colony-Stimulating Factor
Drug · Procedure · Other + 1 more
Lead sponsor
Emory University
Other
Eligibility
18 Years and older
Enrollment
94 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
1
States / cities
Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Jul 23, 2026 · Synced Oct 1, 2026, 6:16 AM EDT
Completed Not applicable Interventional

Childhood Asthma Research and Education (CARE) Network Trial - Acute Intervention Management Strategies (AIMS)

NCT00319488
View directory record Official record
Conditions
Asthma, Lung Diseases
Interventions
Inhaled Corticosteroid (Budesonide), Leukotriene Receptor Antagonist (Montelukast Sodium), Inhaled Albuterol
Drug
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Eligibility
12 Months to 59 Months
Enrollment
238 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2006
U.S. locations
6
States / cities
Tucson, Arizona • La Jolla, California • Denver, Colorado + 3 more
Source: ClinicalTrials.gov public record
Updated Jul 29, 2016 · Synced Oct 1, 2026, 6:16 AM EDT
Completed No phase listed Observational

Functional Dyspepsia (FD) - Clinical Response to Montelukast in Children

NCT02360696
View directory record Official record
Conditions
Eosinophilia, Dyspepsia
Interventions
Not listed
Lead sponsor
Children's Mercy Hospital Kansas City
Other
Eligibility
8 Years to 17 Years
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
1
States / cities
Kansas City, Missouri
Source: ClinicalTrials.gov public record
Updated May 16, 2019 · Synced Oct 1, 2026, 6:16 AM EDT
Completed Phase 2 Interventional

A Study to Evaluate Efficacy and Safety of ADC3680 in Subjects With Inadequately-Controlled Asthma

NCT01730027
View directory record Official record
Conditions
Asthma
Interventions
ADC3680, Placebo, montelukast
Drug
Lead sponsor
Pulmagen Therapeutics
Industry
Eligibility
18 Years to 50 Years
Enrollment
248 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
35
States / cities
Birmingham, Alabama • Huntington Beach, California • Riverside, California + 32 more
Source: ClinicalTrials.gov public record
Updated Oct 6, 2017 · Synced Oct 1, 2026, 6:16 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 17, 2014 · Synced Oct 1, 2026, 6:16 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 9, 2026 · Synced Oct 1, 2026, 6:16 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 7, 2024 · Synced Oct 1, 2026, 6:16 AM EDT
Completed Phase 2 Interventional

Daratumumab in STK11 Mutated NSCLC

NCT05807048
View directory record Official record
Conditions
Non-small Cell Lung Cancer With STK11/LKB1 Mutation
Interventions
Daratumumab and Hyaluronidase-fihj, Pre-Intervention Medication, Post-Intervention Medication
Drug
Lead sponsor
NYU Langone Health
Other
Eligibility
18 Years to 100 Years
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Mar 10, 2026 · Synced Oct 1, 2026, 6:16 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 19, 2020 · Synced Oct 1, 2026, 6:16 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 21, 2015 · Synced Oct 1, 2026, 6:16 AM EDT
Completed Phase 4 Interventional

Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal Allergic Rhinitis Subjects in an Allergen Exposure Unit

NCT00637611
View directory record Official record
Conditions
Seasonal Allergic Rhinitis
Interventions
Fexofenadine HCl
Drug
Lead sponsor
Sanofi
Industry
Eligibility
15 Years and older
Enrollment
1,010 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003
U.S. locations
1
States / cities
Bridgewater, New Jersey
Source: ClinicalTrials.gov public record
Updated Jan 12, 2011 · Synced Oct 1, 2026, 6:16 AM EDT
Recruiting Phase 1 Interventional

Clinical Evaluation of Montelukast in Veterans With Gulf War Illness

NCT05992311
View directory record Official record
Conditions
Gulf War Syndrome
Interventions
Montelukast, Placebo
Drug · Other
Lead sponsor
Baylor College of Medicine
Other
Eligibility
50 Years to 70 Years
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Sep 1, 2026 · Synced Oct 1, 2026, 6:16 AM EDT
Completed Phase 3 Interventional

Long-Term Safety Performance of Fexofenadine in Asthma

NCT00045955
View directory record Official record
Conditions
Asthma
Interventions
Fexofenadine, Comparator = Montelukast
Drug
Lead sponsor
Sanofi
Industry
Eligibility
12 Years to 80 Years
Enrollment
1,200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2002 – 2003
U.S. locations
1
States / cities
Bridgewater, New Jersey
Source: ClinicalTrials.gov public record
Updated Aug 21, 2008 · Synced Oct 1, 2026, 6:16 AM EDT
Terminated Phase 3 Interventional Results available

Targeting Leukotrienes in Kidney Disease

NCT05362474
View directory record Official record
Conditions
Diabetic Kidney Disease
Interventions
Montelukast
Drug
Lead sponsor
University of Colorado, Denver
Other
Eligibility
30 Years to 70 Years
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
1
States / cities
Aurora, Colorado
Source: ClinicalTrials.gov public record
Updated May 30, 2025 · Synced Oct 1, 2026, 6:16 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 23, 2018 · Synced Oct 1, 2026, 6:16 AM EDT