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Showing 1–24 of 47 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Montelukast/ Singulair Clear all
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 27, 2026, 5:33 PM EDT
Completed Not applicable Interventional Results available

The Effect of Montelukast on Asthma Control in Overweight/Obese Atopic Asthmatics

NCT01329939
View directory record Official record
Conditions
Asthma, Obesity, Inflammation
Interventions
Montelukast, Placebo
Drug
Lead sponsor
Northwell Health
Other
Eligibility
7 Years to 17 Years
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2014
U.S. locations
1
States / cities
Great Neck, New York
Source: ClinicalTrials.gov public record
Updated Apr 6, 2016 · Synced Sep 27, 2026, 5:33 PM EDT
Completed Phase 3 Interventional

A Pilot Study of Montelukast Sodium (Singulair) in Older Adults With Asthma or Chronic Obstructive Pulmonary Disease

NCT00162864
View directory record Official record
Conditions
Asthma, COPD
Interventions
montelukast sodium
Drug
Lead sponsor
Kaiser Permanente
Other
Eligibility
50 Years and older
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1999 – 2002
U.S. locations
1
States / cities
Portland, Oregon
Source: ClinicalTrials.gov public record
Updated Mar 23, 2006 · Synced Sep 27, 2026, 5:33 PM EDT
Withdrawn Phase 3 Interventional Accepts healthy volunteers

Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

NCT01702701
View directory record Official record
Conditions
Eosinophilic Esophagitis, Dysphagia
Interventions
Montelukast, Fluticasone
Drug
Lead sponsor
Medical College of Wisconsin
Other
Eligibility
18 Years and older
Healthy volunteers
Accepts healthy volunteers
Timeline
2012 – 2017
U.S. locations
2
States / cities
Milwaukee, Wisconsin
Source: ClinicalTrials.gov public record
Updated Aug 27, 2019 · Synced Sep 27, 2026, 5:33 PM 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 27, 2026, 5:33 PM 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 8, 2009 · Synced Sep 27, 2026, 5:33 PM EDT
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 27, 2026, 5:33 PM EDT
Recruiting Phase 1Phase 2 Interventional

PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia

NCT07101640
View directory record Official record
Conditions
Bronchopulmonary Dysplasia (BPD), Premature Births, Critical Illness
Interventions
montelukast 4 mg granule, Placebo
Drug
Lead sponsor
Duke University
Other
Eligibility
7 Days to 28 Days
Enrollment
28 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
5
States / cities
Little Rock, Arkansas • Amherst, Massachusetts • Las Vegas, Nevada + 2 more
Source: ClinicalTrials.gov public record
Updated Jul 13, 2026 · Synced Sep 27, 2026, 5:33 PM EDT
Completed Not applicable Interventional

Transporter Mediated Uptake of Montelukast

NCT00513760
View directory record Official record
Conditions
Asthma
Interventions
Grapefruit juice, Orange Juice, Gatorade
Dietary Supplement
Lead sponsor
Nemours Children's Clinic
Other
Eligibility
15 Years to 18 Years
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2014
U.S. locations
1
States / cities
Jacksonville, Florida
Source: ClinicalTrials.gov public record
Updated Feb 9, 2025 · Synced Sep 27, 2026, 5:33 PM EDT
Completed Phase 4 Interventional

Asthma in the Elderly: The Effect of Montelukast

NCT02635334
View directory record Official record
Conditions
Asthma
Interventions
Montelukast 10 mg orally, Placebo
Drug · Other
Lead sponsor
Rohr and Columbo Asthma, Allergy and Immunology Specialists, P.C.
Other
Eligibility
65 Years and older
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
1
States / cities
Bryn Mawr, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Oct 4, 2016 · Synced Sep 27, 2026, 5:33 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 27, 2026, 5:33 PM EDT
Completed Not applicable Interventional Results available

Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma

NCT00359073
View directory record Official record
Conditions
Asthma
Interventions
montelukast, placebo
Drug
Lead sponsor
University of Wisconsin, Madison
Other
Eligibility
18 Years to 65 Years
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2009
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Mar 12, 2018 · Synced Sep 27, 2026, 5:33 PM 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 16, 2014 · Synced Sep 27, 2026, 5:33 PM 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 28, 2016 · Synced Sep 27, 2026, 5:33 PM 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 20, 2009 · Synced Sep 27, 2026, 5:33 PM EDT
Recruiting Early Phase 1 Interventional

MOntelukast as a Potential CHondroprotective Treatment Following Anterior Cruciate Ligament Reconstruction (MOCHA Trial)

NCT04572256
View directory record Official record
Conditions
ACL Injury, Meniscus Tear, Post-traumatic Osteoarthritis
Interventions
Montelukast, Placebo
Drug
Lead sponsor
Austin V Stone
Other
Eligibility
25 Years to 50 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
1
States / cities
Lexington, Kentucky
Source: ClinicalTrials.gov public record
Updated Jun 9, 2026 · Synced Sep 27, 2026, 5:33 PM 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 27, 2026, 5:33 PM 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 27, 2026, 5:33 PM 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 27, 2026, 5:33 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 27, 2026, 5:33 PM 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 27, 2026, 5:33 PM 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 27, 2026, 5:33 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 27, 2026, 5:33 PM EDT
Completed Phase 4 Interventional Results available

A Pilot Study to Determine the Feasibility and Utility of Implementing of the Full Scale TOM Trial

NCT01696214
View directory record Official record
Conditions
Asthma
Interventions
Fluticasone 250 mg/salmeterol 50 mg, Montelukast 10mg, Theophylline 400 mg, ipratropium
Drug
Lead sponsor
University of California, San Diego
Other
Eligibility
18 Years to 50 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2016
U.S. locations
1
States / cities
San Diego, California
Source: ClinicalTrials.gov public record
Updated Jan 22, 2019 · Synced Sep 27, 2026, 5:33 PM EDT