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ClinicalTrials.gov public records Last synced Oct 18, 2026, 11:16 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Showing 49–72 of 108 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Montelukast 10mg Clear all
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 7, 2016 · Synced Oct 18, 2026, 11:16 PM EDT
Completed Phase 2 Interventional Results available

Targeted Therapy of Bronchiolitis Obliterans Syndrome

NCT01307462
View directory record Official record
Conditions
Bronchiolitis Obliterans
Interventions
fluticasone propionate, montelukast sodium, azithromycin
Drug
Lead sponsor
Stephanie Lee
Other
Eligibility
6 Years to 99 Years
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2015
U.S. locations
11
States / cities
Scottsdale, Arizona • Stanford, California • Tampa, Florida + 8 more
Source: ClinicalTrials.gov public record
Updated Oct 4, 2017 · Synced Oct 18, 2026, 11:16 PM 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 10, 2026 · Synced Oct 18, 2026, 11:16 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin

NCT03131973
View directory record Official record
Conditions
Rheumatoid Arthritis
Interventions
BMS-986195, Methotrexate, Leucovorin, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, Pravastatin
Drug
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
18 Years to 50 Years
Enrollment
26 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017
U.S. locations
1
States / cities
Austin, Texas
Source: ClinicalTrials.gov public record
Updated Dec 15, 2017 · Synced Oct 18, 2026, 11:16 PM EDT
Completed Phase 3 Interventional Results available

Effect of Fluticasone Furoate Inhalation Powder on the Hypothalamic-pituitary-adrenocortical Axis of Children Aged 5-11 Years With Asthma

NCT02483975
View directory record Official record
Conditions
Asthma
Interventions
FF, Placebo, Montelukast, Albuterol/Salbutamol
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
5 Years to 11 Years
Enrollment
111 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
14
States / cities
Little Rock, Arkansas • Alhambra, California • Costa Mesa, California + 8 more
Source: ClinicalTrials.gov public record
Updated Apr 27, 2020 · Synced Oct 18, 2026, 11:16 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 17, 2014 · Synced Oct 18, 2026, 11:16 PM 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 9, 2018 · Synced Oct 18, 2026, 11:16 PM EDT
Not listed Phase 2Phase 3 Interventional

Montelukast With Status Asthmaticus, Ages 6-18

NCT00494572
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
6 Years to 18 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 16, 2008 · Synced Oct 18, 2026, 11:16 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 10, 2026 · Synced Oct 18, 2026, 11:16 PM 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 21, 2008 · Synced Oct 18, 2026, 11:16 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 28, 2019 · Synced Oct 18, 2026, 11:16 PM EDT
Completed Phase 4 Interventional Results available

A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children

NCT00189462
View directory record Official record
Conditions
Acute Otitis Media, Otitis Media, Ear Infection
Interventions
Montelukast, Placebo
Drug
Lead sponsor
Deborah Gentile
Other
Eligibility
18 Months to 5 Years
Enrollment
99 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2005
U.S. locations
2
States / cities
Bellevue, Pennsylvania • Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Nov 18, 2020 · Synced Oct 18, 2026, 11:16 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Phase 1 Drug-drug Interaction Study in Healthy Volunteers

NCT02227173
View directory record Official record
Conditions
Drug-drug Interaction Study
Interventions
BMS-986020, Montelukast, Flurbiprofen, Digoxin
Drug
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
18 Years to 50 Years
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Nov 18, 2014 · Synced Oct 18, 2026, 11:16 PM EDT
Completed Phase 3 Interventional

Predicting the Response to Montelukast by Genetic Variation in Asthmatics

NCT00116324
View directory record Official record
Conditions
Asthma
Interventions
Montelukast
Drug
Lead sponsor
Brigham and Women's Hospital
Other
Eligibility
18 Years to 65 Years
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2006
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated May 18, 2021 · Synced Oct 18, 2026, 11:16 PM 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 16, 2016 · Synced Oct 18, 2026, 11:16 PM EDT
Completed Phase 3 Interventional Results available

Individualized Therapy For Asthma in Toddlers

NCT01606306
View directory record Official record
Conditions
Asthma, Wheezing
Interventions
daily fluticasone propionate, Montelukast, as-needed fluticasone propionate
Drug
Lead sponsor
Milton S. Hershey Medical Center
Other
Eligibility
12 Months to 59 Months
Enrollment
300 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
13
States / cities
Tucson, Arizona • Oakland, California • San Francisco, California + 9 more
Source: ClinicalTrials.gov public record
Updated Mar 16, 2017 · Synced Oct 18, 2026, 11:16 PM EDT
Completed Phase 4 Interventional Results available

Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera

NCT02410278
View directory record Official record
Conditions
Multiple Sclerosis
Interventions
dimethyl fumarate, montelukast, Placebo
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years and older
Enrollment
102 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
50
States / cities
Jonesboro, Arkansas • Carmichael, California • La Jolla, California + 46 more
Source: ClinicalTrials.gov public record
Updated Mar 31, 2020 · Synced Oct 18, 2026, 11:16 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 3, 2015 · Synced Oct 18, 2026, 11:16 PM 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 2, 2012 · Synced Oct 18, 2026, 11:16 PM 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 23, 2026 · Synced Oct 18, 2026, 11:16 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 16, 2009 · Synced Oct 18, 2026, 11:16 PM EDT
Completed Phase 2 Interventional

A Placebo and Active Controlled Study of ONO-6950 in Asthmatic Patients

NCT01536041
View directory record Official record
Conditions
Asthma
Interventions
ONO-6950, Montelukast, Placebo
Drug
Lead sponsor
Ono Pharma USA Inc
Industry
Eligibility
18 Years to 60 Years
Enrollment
59 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2012
U.S. locations
9
States / cities
Los Angeles, California • San Diego, California • Denver, Colorado + 6 more
Source: ClinicalTrials.gov public record
Updated Feb 14, 2014 · Synced Oct 18, 2026, 11:16 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 10, 2026 · Synced Oct 18, 2026, 11:16 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study on Effects of BMS-955176 on the Pharmacokinetics of Probe Substrates

NCT02578277
View directory record Official record
Conditions
HIV Infections
Interventions
CYP and transporter probe substrates, BMS-955176, BMS-955176 plus CYP and transporter probe substrates
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years to 50 Years
Enrollment
59 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015
U.S. locations
1
States / cities
Austin, Texas
Source: ClinicalTrials.gov public record
Updated Jul 13, 2018 · Synced Oct 18, 2026, 11:16 PM EDT