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ClinicalTrials.gov public records Last synced Oct 26, 2026, 8:52 PM EDT

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Showing 1–24 of 78 matching trials from the live ClinicalTrials.gov search.
Conditions
Asthma
Interventions
Fluticasone Propionate 100mcg via ACCUHALER/DISKUS, GSK2190915 100mg, GSK2190915 10mg, GSK2190915 300mg, GSK2190915 30mg, Montelukast 10mg, Placebo GSK2190915 one tablet, Placebo montelukast, Placebo fluticasone propionate via ACCUHALER/DISKUS, Placebo GSK2190915 two tablets
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
12 Years and older · Female only
Enrollment
700 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
22
States / cities
Birmingham, Alabama • Huntington Beach, California • Newport Beach, California + 19 more
Terminated Phase 4 Interventional Accepts healthy volunteers Results available

The Addition of Montelukast to Fluticasone in the Treatment of Perennial Allergic Rhinitis

NCT00119015
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
Conditions
Asthma
Interventions
Montelukast 5-mg orally added to standard therapy
Drug
Lead sponsor
Washington University School of Medicine
Other
Eligibility
6 Years to 14 Years
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2001 – 2005
U.S. locations
1
States / cities
St Louis, Missouri
Withdrawn Not applicable Interventional Accepts healthy volunteers

Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes

NCT00375232
Conditions
Exercise-Induced Bronchospasm
Interventions
Administration of montelukast or placebo
Drug
Lead sponsor
Indiana University
Other
Eligibility
18 Years to 50 Years
Healthy volunteers
Accepts healthy volunteers
Timeline
Started 2006
U.S. locations
1
States / cities
Indianapolis, Indiana
Conditions
Asthma
Interventions
fluticasone propionate/salmeterol, fluticasone propionate, montelukast
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
15 Years and older
Enrollment
600 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2007
U.S. locations
80
States / cities
Ozark, Alabama • Tempe, Arizona • Little Rock, Arkansas + 67 more
Completed Phase 2 Interventional Results available

Montelukast Therapy on Alzheimer's Disease

NCT03991988
Conditions
Alzheimer Disease
Interventions
Montelukast, Placebo oral tablet
Drug
Lead sponsor
Emory University
Other
Eligibility
50 Years and older
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
4
States / cities
Atlanta, Georgia
Conditions
Diabetes, Kidney Disease, Vascular Disease, Retinopathy
Interventions
Montelukast, Placebo
Drug
Lead sponsor
University of Colorado, Denver
Other
Eligibility
18 Years to 80 Years
Enrollment
110 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2031
U.S. locations
1
States / cities
Aurora, Colorado
Completed Phase 3 Interventional Accepts healthy volunteers Results available

Does Montelukast Decrease Post Adenotonsillectomy Pain in Children

NCT02793375
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
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
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
Completed Early Phase 1 Interventional Accepts healthy volunteers

Bioequivalency Study of Montelukast 10 mg Tablets Under Fasted Conditions

NCT01659931
Conditions
Asthma
Interventions
Montelukast, Singulair
Drug
Lead sponsor
Roxane Laboratories
Industry
Eligibility
18 Years to 45 Years
Enrollment
34 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008
U.S. locations
1
States / cities
Fargo, North Dakota
Completed Phase 3 Interventional Results available

ACTIV-6: COVID-19 Study of Repurposed Medications

NCT04885530
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
Completed Not applicable Interventional Accepts healthy volunteers

Montelukast in the Treatment of Duodenal Eosinophilia

NCT00148603
Conditions
Eosinophilic Gastroenteritis, Dyspepsia
Interventions
montelukast
Drug
Lead sponsor
Children's Mercy Hospital Kansas City
Other
Eligibility
8 Years to 17 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2005 – 2006
U.S. locations
1
States / cities
Kansas City, Missouri
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
Conditions
Asthma
Interventions
BI 671800, Placebo, Montelukast
Drug
Lead sponsor
Boehringer Ingelheim
Industry
Eligibility
18 Years to 65 Years
Enrollment
243 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
6
States / cities
Denver, Colorado • North Dartmouth, Massachusetts • Plymouth, Minnesota + 3 more
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
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
HIV Infections
Interventions
GSK3640254 200 mg, Caffeine 200 mg, Metoprolol 100 mg, Montelukast 10 mg, Flurbiprofen 100 mg, Omeprazole 40 mg, Midazolam 5 mg (2.5 mL), Digoxin 0.25 mg, Pravastatin 40 mg
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years to 50 Years
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2021
U.S. locations
1
States / cities
Las Vegas, Nevada
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
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
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
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
Conditions
Asthma
Interventions
FP 100, GSK2190915 100, GSK2190915 300, montelukast, placebo, FP/SAL 100/50
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
12 Years and older · Female only
Enrollment
162 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2011
U.S. locations
32
States / cities
Birmingham, Alabama • Little Rock, Arkansas • Huntington Beach, California + 28 more
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