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ClinicalTrials.gov public records Last synced Oct 17, 2026, 9:57 AM EDT

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Showing 1–24 of 108 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: montelukast Clear all
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 7, 2008 · Synced Oct 17, 2026, 9:57 AM 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 11, 2025 · Synced Oct 17, 2026, 9:57 AM EDT
Completed Phase 2 Interventional Results available

BI 671800 in Asthmatic Patients on Inhaled Corticosteroids

NCT01103349
View directory record Official record
Conditions
Asthma
Interventions
BI 671800, Placebo, Montelukast
Drug
Lead sponsor
Boehringer Ingelheim
Industry
Eligibility
18 Years to 65 Years
Enrollment
243 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
6
States / cities
Denver, Colorado • North Dartmouth, Massachusetts • Plymouth, Minnesota + 3 more
Source: ClinicalTrials.gov public record
Updated May 31, 2022 · Synced Oct 17, 2026, 9:57 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 17, 2026, 9:57 AM EDT
Completed Phase 1 Interventional

A Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Treatments for the Treatment of Patients With Multiple Myeloma

NCT01998971
View directory record Official record
Conditions
Multiple Myeloma
Interventions
Daratumumab, Velcade, Pomalidomide, Dexamethasone, Melphalan, Prednisone, Thalidomide, Diphenhydramine, Acetaminophen, Carfilzomib, Lenalidomide, Montelukast
Drug
Lead sponsor
Janssen Research & Development, LLC
Industry
Eligibility
18 Years and older
Enrollment
240 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2024
U.S. locations
10
States / cities
Duarte, California • Atlanta, Georgia • Chicago, Illinois + 7 more
Source: ClinicalTrials.gov public record
Updated Apr 25, 2025 · Synced Oct 17, 2026, 9:57 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 2, 2026 · Synced Oct 17, 2026, 9:57 AM EDT
Not yet recruiting Phase 4 Interventional

MIRACLE-T2D Montelukast Intervention for Renal, Cardiovascular and Eye Health in Type 2 Diabetes

NCT07685886
View directory record Official record
Conditions
Diabetes, Kidney Disease, Vascular Disease, Retinopathy
Interventions
Montelukast, Placebo
Drug
Lead sponsor
University of Colorado, Denver
Other
Eligibility
18 Years to 80 Years
Enrollment
110 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2031
U.S. locations
1
States / cities
Aurora, Colorado
Source: ClinicalTrials.gov public record
Updated Jul 6, 2026 · Synced Oct 17, 2026, 9:57 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 12, 2025 · Synced Oct 17, 2026, 9:57 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 7, 2019 · Synced Oct 17, 2026, 9:57 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 17, 2026, 9:57 AM 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 10, 2012 · Synced Oct 17, 2026, 9:57 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 17, 2026, 9:57 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 30, 2020 · Synced Oct 17, 2026, 9:57 AM 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 21, 2026 · Synced Oct 17, 2026, 9:57 AM EDT
Terminated Phase 4 Interventional Results available

Effect of Montelukast Therapy in Obstructive Sleep Apnea(OSA) Children

NCT01027806
View directory record Official record
Conditions
Obstructive Sleep Apnea
Interventions
Montelukast
Drug
Lead sponsor
University of Chicago
Other
Eligibility
2 Years to 10 Years
Enrollment
64 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2014
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated May 3, 2019 · Synced Oct 17, 2026, 9:57 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 17, 2026, 9:57 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 17, 2026, 9:57 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 17, 2026, 9:57 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 – 2031
U.S. locations
1
States / cities
Aurora, Colorado
Source: ClinicalTrials.gov public record
Updated Oct 6, 2026 · Synced Oct 17, 2026, 9:57 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 25, 2026 · Synced Oct 17, 2026, 9:57 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 9, 2009 · Synced Oct 17, 2026, 9:57 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 10, 2025 · Synced Oct 17, 2026, 9:57 AM 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 19, 2024 · Synced Oct 17, 2026, 9:57 AM EDT
Completed Phase 2 Interventional Results available

Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age

NCT01156792
View directory record Official record
Conditions
Asthma
Interventions
FP 100, GSK2190915 100, GSK2190915 300, montelukast, placebo, FP/SAL 100/50
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
12 Years and older · Female only
Enrollment
162 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
32
States / cities
Birmingham, Alabama • Little Rock, Arkansas • Huntington Beach, California + 28 more
Source: ClinicalTrials.gov public record
Updated Apr 5, 2017 · Synced Oct 17, 2026, 9:57 AM EDT