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Showing 25–48 of 24 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Montelukast 10mg Clear all
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 1, 2026, 10:27 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Trial of Montelukast in Eosinophilic Esophagitis

NCT00511316
View directory record Official record
Conditions
Eosinophilic Esophagitis
Interventions
Montelukast/ Singulair, Placebo
Drug
Lead sponsor
Mayo Clinic
Other
Eligibility
18 Years to 100 Years
Enrollment
41 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2007 – 2015
U.S. locations
1
States / cities
Rochester, Minnesota
Source: ClinicalTrials.gov public record
Updated Nov 2, 2015 · Synced Sep 1, 2026, 10:27 PM EDT
Completed Not applicable Interventional Accepts healthy volunteers

Effects of Intranasal Corticosteroid and Montelukast On Nasal Allergen Challenges*

NCT01240889
View directory record Official record
Conditions
Allergy
Interventions
Fluticasone, Fluticason
Drug
Lead sponsor
Creighton University
Other
Eligibility
19 Years to 60 Years
Enrollment
60 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2010 – 2011
U.S. locations
1
States / cities
Omaha, Nebraska
Source: ClinicalTrials.gov public record
Updated Oct 9, 2012 · Synced Sep 1, 2026, 10:27 PM 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 1, 2026, 10:27 PM EDT
Completed No phase listed Observational Accepts healthy volunteers Results available

Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Montelukast vs Fluticasone

NCT05457855
View directory record Official record
Conditions
Asthma
Interventions
Montelukast, Fluticasone
Drug
Lead sponsor
Brigham and Women's Hospital
Other
Eligibility
65 Years and older
Enrollment
51,533 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2023
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Aug 10, 2025 · Synced Sep 1, 2026, 10:27 PM EDT
Completed No phase listed Observational

Early Detection and Management of Bronchiolitis Obliterans Syndrome Following Pediatric Hematopoietic Stem Cell Transplantation

NCT03072849
View directory record Official record
Conditions
Bronchiolitis Obliterans Syndrome
Interventions
Pulmonary function testing, FAM Therapy
Procedure · Drug
Lead sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Other
Eligibility
6 Years to 18 Years
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2020
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Nov 18, 2024 · Synced Sep 1, 2026, 10:27 PM 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 22, 2026 · Synced Sep 1, 2026, 10:27 PM 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 1, 2026, 10:27 PM 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 1, 2026, 10:27 PM 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 1, 2026, 10:27 PM EDT
Not listed Not applicable Interventional

Evaluation Montelukast in the Treatment of Status Asthmaticus

NCT01770899
View directory record Official record
Conditions
Status Asthmaticus
Interventions
Montelukast, Placebo
Drug
Lead sponsor
Corrie Fletcher
Other
Eligibility
2 Years to 14 Years
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2013
U.S. locations
1
States / cities
Oak Lawn, Illinois
Source: ClinicalTrials.gov public record
Updated Feb 24, 2013 · Synced Sep 1, 2026, 10:27 PM EDT
Withdrawn Not applicable Interventional Accepts healthy volunteers

Adolescent and Adult Subjects With Asthma and Seasonal Allergic Rhinitis Receiving Advair Diskus or Placebo

NCT00385463
View directory record Official record
Conditions
Asthma, Seasonal Allergic Rhinitis
Interventions
Adding Advair Diskus 100/50mcg (FSC) BID and Singulair 10mg is added to placebo Diskus BID
Drug
Lead sponsor
Creighton University
Other
Eligibility
15 Years to 75 Years
Healthy volunteers
Accepts healthy volunteers
Timeline
2006 – 2007
U.S. locations
1
States / cities
Omaha, Nebraska
Source: ClinicalTrials.gov public record
Updated Jun 15, 2016 · Synced Sep 1, 2026, 10:27 PM 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 1, 2026, 10:27 PM EDT
Completed Phase 4 Interventional

Fexofenadine HCl 180 mg, Montelukast Sodium 10 mg and Placebo in Suppression of Wheal and Flare Induced by Seasonal Allergen

NCT00638118
View directory record Official record
Conditions
Allergic Rhinitis
Interventions
Fexofenadine
Drug
Lead sponsor
Sanofi
Industry
Eligibility
15 Years to 55 Years
Enrollment
48 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 10, 2011 · Synced Sep 1, 2026, 10:27 PM EDT
Completed Not applicable Interventional Accepts healthy volunteers

Montelukast in the Treatment of Duodenal Eosinophilia

NCT00148603
View directory record Official record
Conditions
Eosinophilic Gastroenteritis, Dyspepsia
Interventions
montelukast
Drug
Lead sponsor
Children's Mercy Hospital Kansas City
Other
Eligibility
8 Years to 17 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2005 – 2006
U.S. locations
1
States / cities
Kansas City, Missouri
Source: ClinicalTrials.gov public record
Updated Dec 28, 2011 · Synced Sep 1, 2026, 10:27 PM 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 1, 2026, 10:27 PM 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 1, 2026, 10:27 PM 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 1, 2026, 10:27 PM 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 9, 2026 · Synced Sep 1, 2026, 10:27 PM EDT
Completed Phase 3 Interventional Accepts healthy volunteers Results available

Does Montelukast Decrease Post Adenotonsillectomy Pain in Children

NCT02793375
View directory record Official record
Conditions
Pain
Interventions
Montelukast, Placebo
Drug
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Other
Eligibility
3 Years to 8 Years
Enrollment
116 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018 – 2024
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Apr 20, 2026 · Synced Sep 1, 2026, 10:27 PM 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 15, 2009 · Synced Sep 1, 2026, 10:27 PM EDT
Completed Phase 3 Interventional Results available

A Study Evaluating the Efficacy and Safety of Lebrikizumab in Adult Patients With Mild to Moderate Asthma

NCT02104674
View directory record Official record
Conditions
Asthma
Interventions
Lebrikizumab, Montelukast, Placebo
Drug · Other
Lead sponsor
Hoffmann-La Roche
Industry
Eligibility
18 Years to 75 Years
Enrollment
313 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2016
U.S. locations
38
States / cities
Birmingham, Alabama • Scottsdale, Arizona • Anaheim, California + 30 more
Source: ClinicalTrials.gov public record
Updated Jul 16, 2026 · Synced Sep 1, 2026, 10:27 PM 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 1, 2026, 10:27 PM EDT
Completed Not applicable Interventional Results available

Trial of Montelukast for Treatment of Acute Bronchiolitis

NCT00863317
View directory record Official record
Conditions
Bronchiolitis
Interventions
montelukast sodium, sucrose
Drug · Other
Lead sponsor
Medical College of Wisconsin
Other
Eligibility
3 Months to 12 Months
Enrollment
141 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2011
U.S. locations
1
States / cities
Milwaukee, Wisconsin
Source: ClinicalTrials.gov public record
Updated Jul 14, 2015 · Synced Sep 1, 2026, 10:27 PM EDT