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ClinicalTrials.gov public records Last synced Oct 17, 2026, 9:34 AM EDT

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Showing 1–24 of 47 matching trials from the live ClinicalTrials.gov search.
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
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
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
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
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
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
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
Completed Phase 1 Interventional Accepts healthy volunteers

Genotype Stratified Pharmacokinetic Study of Montelukast

NCT01086527
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
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
Conditions
Status Asthmaticus
Interventions
Montelukast, Placebo
Drug
Lead sponsor
Corrie Fletcher
Other
Eligibility
2 Years to 14 Years
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
Started 2013
U.S. locations
1
States / cities
Oak Lawn, Illinois
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
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
Completed Not applicable Interventional Results available

Trial of Montelukast for Treatment of Acute Bronchiolitis

NCT00863317
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
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
Completed Phase 2 Interventional Results available

Targeted Therapy of Bronchiolitis Obliterans Syndrome

NCT01307462
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
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
Terminated Phase 4 Interventional Results available

Moderate to Persistent Asthma in the Obese Subject

NCT01016847
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
Completed Phase 2 Interventional Results available

Montelukast to Treat Bronchiolitis Obliterans

NCT00656058
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
Withdrawn Phase 3 Interventional Accepts healthy volunteers

Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone

NCT01702701
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
Completed Phase 3 Interventional Results available

Individualized Therapy For Asthma in Toddlers

NCT01606306
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
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
Completed Phase 1 Interventional Accepts healthy volunteers

Trial of Montelukast in Eosinophilic Esophagitis

NCT00511316
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
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
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