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ClinicalTrials.gov public records Last synced Oct 1, 2026, 4:44 AM EDT

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Showing 1–24 of 55 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Montelukast Placebo Clear all
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 17, 2025 · Synced Oct 1, 2026, 4:44 AM EDT
Completed Not applicable Interventional Accepts healthy volunteers

Leukotriene Antagonism in Recruitment of CD49d Expressing Neutrophils in Atopic Subjects

NCT03039101
View directory record Official record
Conditions
Nasal Allergy
Interventions
Nasal lavage, Nasal allergen challenge, Epicutaneous skin testing, Peripheral blood, Montelukast 10Mg Tablet, Placebo Oral Tablet
Procedure · Drug
Lead sponsor
Mitchell Grayson
Other
Eligibility
21 Years to 65 Years
Enrollment
25 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017 – 2018
U.S. locations
1
States / cities
Columbus, Ohio
Source: ClinicalTrials.gov public record
Updated Oct 7, 2019 · Synced Oct 1, 2026, 4:44 AM EDT
Not yet recruiting Phase 4 Interventional

MIRACLE-T2D Montelukast Intervention for Renal, Cardiovascular and Eye Health in Type 2 Diabetes

NCT07685886
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jul 6, 2026 · Synced Oct 1, 2026, 4:44 AM EDT
Completed Phase 3 Interventional Accepts healthy volunteers Results available

Does Montelukast Decrease Post Adenotonsillectomy Pain in Children

NCT02793375
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Apr 21, 2026 · Synced Oct 1, 2026, 4:44 AM EDT
Completed Phase 4 Interventional

Trial of Asthma Patient Education (TAPE)

NCT00148408
View directory record Official record
Conditions
Asthma
Interventions
Montelukast, Education
Drug · Behavioral
Lead sponsor
American Lung Association Asthma Clinical Research Centers
Other
Eligibility
15 Years and older
Enrollment
600 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2005
U.S. locations
20
States / cities
Birmingham, Alabama • San Diego, California • Denver, Colorado + 17 more
Source: ClinicalTrials.gov public record
Updated Apr 30, 2010 · Synced Oct 1, 2026, 4:44 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 11, 2011 · Synced Oct 1, 2026, 4:44 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 23, 2019 · Synced Oct 1, 2026, 4:44 AM EDT
Completed Phase 4 Interventional Results available

Effects of a Orally Inhaled Fluticasone Furoate on Growth Velocity in Prepubertal, Paediatric Subjects With Asthma Over a Year

NCT02889809
View directory record Official record
Conditions
Asthma
Interventions
Fluticasone furoate, Placebo, Montelukast, Short Acting Beta 2 Agonist
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
5 Years to 9 Years
Enrollment
477 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2021
U.S. locations
18
States / cities
Little Rock, Arkansas • Huntington Beach, California • Homestead, Florida + 12 more
Source: ClinicalTrials.gov public record
Updated Jan 17, 2024 · Synced Oct 1, 2026, 4:44 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 7, 2016 · Synced Oct 1, 2026, 4:44 AM EDT
Completed Phase 2 Interventional Results available

Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily

NCT01147744
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Oct 2, 2017 · Synced Oct 1, 2026, 4:44 AM EDT
Completed Phase 3 Interventional Results available

Montelukast and Inhaled Nasal Steroid Tx in Adult Obstructive Sleep Apnea (OSA)

NCT01089647
View directory record Official record
Conditions
Obstructive Sleep Apnea
Interventions
budesonide and montelukast, Placebo
Drug
Lead sponsor
Romaker & Associates
Other
Eligibility
18 Years to 100 Years
Enrollment
34 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2014
U.S. locations
2
States / cities
Kansas City, Missouri
Source: ClinicalTrials.gov public record
Updated Dec 3, 2018 · Synced Oct 1, 2026, 4:44 AM EDT
Completed Phase 2 Interventional Results available

Phase 2 Study of Montelukast for the Treatment of Sickle Cell Anemia

NCT01960413
View directory record Official record
Conditions
Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)
Interventions
Montelukast added to Hydroxyurea, Placebo added to Hydroxyurea
Drug
Lead sponsor
Vanderbilt University Medical Center
Other
Eligibility
16 Years to 70 Years
Enrollment
46 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2018
U.S. locations
2
States / cities
Nashville, Tennessee • Milwaukee, Wisconsin
Source: ClinicalTrials.gov public record
Updated Mar 26, 2019 · Synced Oct 1, 2026, 4:44 AM EDT
Completed Phase 2Phase 3 Interventional Results available

Montelukast for Early Life Wheezing

NCT00115297
View directory record Official record
Conditions
Lung Diseases, Asthma
Interventions
Montelukast, Placebo
Drug
Lead sponsor
University of Massachusetts, Worcester
Other
Eligibility
3 Months to 3 Years
Enrollment
62 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2016
U.S. locations
1
States / cities
Worcester, Massachusetts
Source: ClinicalTrials.gov public record
Updated Mar 14, 2017 · Synced Oct 1, 2026, 4:44 AM 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 1, 2026, 4:44 AM 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 1, 2026, 4:44 AM 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 30, 2020 · Synced Oct 1, 2026, 4:44 AM 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 18, 2024 · Synced Oct 1, 2026, 4:44 AM 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 1, 2026, 4:44 AM EDT
Recruiting Phase 4 Interventional

Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes

NCT05498116
View directory record Official record
Conditions
Albuminuria
Interventions
Montelukast, Placebo
Drug · Other
Lead sponsor
University of Colorado, Denver
Other
Eligibility
18 Years to 80 Years
Enrollment
50 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
1
States / cities
Aurora, Colorado
Source: ClinicalTrials.gov public record
Updated Jun 30, 2026 · Synced Oct 1, 2026, 4:44 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 10, 2026 · Synced Oct 1, 2026, 4:44 AM EDT
Completed Phase 2 Interventional Results available

Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age

NCT01156792
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Apr 5, 2017 · Synced Oct 1, 2026, 4:44 AM EDT
Terminated Phase 4 Interventional

Childhood Asthma Research and Education (CARE) Network Trial - Montelukast or Azithromycin for Reduction of Inhaled Corticosteroids in Childhood Asthma (MARS)

NCT00471809
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jul 29, 2016 · Synced Oct 1, 2026, 4:44 AM EDT
Not listed Not applicable Interventional

Evaluation Montelukast in the Treatment of Status Asthmaticus

NCT01770899
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Feb 25, 2013 · Synced Oct 1, 2026, 4:44 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 2, 2026 · Synced Oct 1, 2026, 4:44 AM EDT