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ClinicalTrials.gov public records Last synced Sep 28, 2026, 3:49 AM EDT

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Showing 25–48 of 24 matching trials from the live ClinicalTrials.gov search.
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Filters: Condition: Montelukast Clear all
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 28, 2026, 3:49 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 28, 2026, 3:49 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 9, 2012 · Synced Sep 28, 2026, 3:49 AM EDT
Withdrawn Phase 2 Interventional

Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations

NCT03277170
View directory record Official record
Conditions
Asthma; Status, Asthma in Children, Asthma Acute, Asthma Attack, Acute Asthma Exacerbation
Interventions
Montelukast Oral Granules
Drug
Lead sponsor
Vanderbilt University Medical Center
Other
Eligibility
5 Years to 17 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
1
States / cities
Nashville, Tennessee
Source: ClinicalTrials.gov public record
Updated Nov 17, 2024 · Synced Sep 28, 2026, 3:49 AM EDT
Completed Phase 4 Interventional Results available

Study Of Allergic Rhinitis In Patients Who Also Have Asthma

NCT00296491
View directory record Official record
Conditions
Asthma
Interventions
fluticasone propionate/salmeterol (FSC), montelukast (MON), fluticasone propionate (FP), placebo nasal, ADVAIR DISKUS, placebo capsule, placebo DISKUS
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
15 Years and older
Enrollment
725 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2007
U.S. locations
104
States / cities
Birmingham, Alabama • Glendale, Arizona • Scottsdale, Arizona + 88 more
Source: ClinicalTrials.gov public record
Updated Dec 15, 2016 · Synced Sep 28, 2026, 3:49 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 28, 2026, 3:49 AM EDT
Completed Phase 2 Interventional Results available

Standard Infusion Carboplatin Versus Prophylactic Extended Infusion Carboplatin in Patients With Patients With Recurrent, Ovary, Fallopian Tube, and Primary Peritoneal Cancer

NCT01248962
View directory record Official record
Conditions
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Interventions
carboplatin
Drug
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Eligibility
21 Years and older · Female only
Enrollment
146 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2018
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Oct 1, 2019 · Synced Sep 28, 2026, 3:49 AM 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 28, 2026, 3:49 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 28, 2026, 3:49 AM EDT
Terminated Phase 4 Interventional

Childhood Asthma Research and Education (CARE) Network Trial - Montelukast or Azithromycin for Reduction of Inhaled Corticosteroids in Childhood Asthma (MARS)

NCT00471809
View directory record Official record
Conditions
Asthma
Interventions
Budesonide + Salmeterol + Azithromycin, Budesonide + Salmeterol + Montelukast, Budesonide + Salmeterol + Placebo
Drug
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Eligibility
6 Years to 17 Years
Enrollment
210 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2007
U.S. locations
6
States / cities
Tucson, Arizona • Los Angeles, California • San Diego, California + 3 more
Source: ClinicalTrials.gov public record
Updated Jul 28, 2016 · Synced Sep 28, 2026, 3:49 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 20, 2026 · Synced Sep 28, 2026, 3:49 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 28, 2026, 3:49 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 28, 2026, 3:49 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 11, 2011 · Synced Sep 28, 2026, 3:49 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 20, 2008 · Synced Sep 28, 2026, 3:49 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 28, 2026, 3:49 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 28, 2026, 3:49 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 28, 2026, 3:49 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 28, 2026, 3:49 AM EDT
Completed Phase 1 Interventional

Montelukast in Very Low Birthweight Infants

NCT00492102
View directory record Official record
Conditions
Bronchopulmonary Dysplasia
Interventions
Montelukast
Drug
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Other
Eligibility
7 Days and older
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2011
U.S. locations
1
States / cities
Cincinnati, Ohio
Source: ClinicalTrials.gov public record
Updated Aug 1, 2012 · Synced Sep 28, 2026, 3:49 AM EDT
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 28, 2026, 3:49 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 1, 2026 · Synced Sep 28, 2026, 3:49 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 9, 2025 · Synced Sep 28, 2026, 3:49 AM 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 28, 2026, 3:49 AM EDT