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Showing 25–47 of 23 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Singulair Clear all
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 24, 2026, 5:40 AM EDT
Completed Phase 3 Interventional Results available

ACTIV-6: COVID-19 Study of Repurposed Medications

NCT04885530
View directory record Official record
Conditions
Covid19
Interventions
Ivermectin, Fluvoxamine, Fluticasone, Placebo, Montelukast, Metformin
Drug · Other
Lead sponsor
Susanna Naggie, MD
Other
Eligibility
30 Years and older
Enrollment
10,956 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
110
States / cities
Chandler, Arizona • Gilbert, Arizona • Mesa, Arizona + 96 more
Source: ClinicalTrials.gov public record
Updated Nov 16, 2025 · Synced Sep 24, 2026, 5:40 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 Aug 31, 2026 · Synced Sep 24, 2026, 5:40 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Withdrawn Not applicable Interventional Accepts healthy volunteers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 24, 2026, 5:40 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 24, 2026, 5:40 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 24, 2026, 5:40 AM 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 24, 2026, 5:40 AM 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 24, 2026, 5:40 AM 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 24, 2026, 5:40 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 24, 2026, 5:40 AM 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 24, 2026, 5:40 AM EDT
Recruiting Phase 2 Interventional

BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)

NCT05922761
View directory record Official record
Conditions
Bronchiolitis Obliterans Syndrome, Bronchiolitis Obliterans, Lung Diseases, Chronic Graft Versus Host Disease
Interventions
Belumosudil, Fluticasone, Azithromycin, Prednisone, Montelukast
Drug
Lead sponsor
Dana-Farber Cancer Institute
Other
Eligibility
18 Years and older
Enrollment
45 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
6
States / cities
Stanford, California • Boston, Massachusetts • Ann Arbor, Michigan + 1 more
Source: ClinicalTrials.gov public record
Updated Jun 9, 2026 · Synced Sep 24, 2026, 5:40 AM 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 24, 2026, 5:40 AM 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 24, 2026, 5:40 AM EDT
Completed Phase 2 Interventional Results available

Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease

NCT04294641
View directory record Official record
Conditions
Chronic GVHD
Interventions
Ibrutinib, ECG, PFT's, CT, Steroid pulse (prednisone), Voriconazole, Posaconazole, Azithromycin, Montelukast, Budesonide, Beclomethasone, Filgrastim, Pegfilgrastim, Erythropoietin, Transfusions, Oral/Skin biopsy
Drug · Diagnostic Test · Other + 1 more
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years and older
Enrollment
10 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
2
States / cities
Bethesda, Maryland • St Louis, Missouri
Source: ClinicalTrials.gov public record
Updated Jan 22, 2026 · Synced Sep 24, 2026, 5:40 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 24, 2026, 5:40 AM 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 24, 2026, 5:40 AM 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 24, 2026, 5:40 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 24, 2026, 5:40 AM 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 24, 2026, 5:40 AM 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 24, 2026, 5:40 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 15, 2009 · Synced Sep 24, 2026, 5:40 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 24, 2026, 5:40 AM EDT