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ClinicalTrials.gov public records Last synced Oct 1, 2026, 10:53 PM EDT

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Showing 25–48 of 55 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Placebo montelukast Clear all
Completed Phase 4 Interventional Results available

Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds

NCT00189475
View directory record Official record
Conditions
Upper Respiratory Infection
Interventions
Montelukast, Placebo
Drug
Lead sponsor
Deborah Gentile
Other
Eligibility
18 Years to 50 Years
Enrollment
84 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2003 – 2007
U.S. locations
1
States / cities
Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Nov 18, 2020 · Synced Oct 1, 2026, 10:53 PM 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, 10:53 PM EDT
Completed Phase 2 Interventional

Dose Finding Study for QAW039 in Asthma

NCT01437735
View directory record Official record
Conditions
Asthma
Interventions
QAW039, Montelukast, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 65 Years
Enrollment
1,043 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
38
States / cities
Scottsdale, Arizona • Encinitas, California • Huntington Beach, California + 33 more
Source: ClinicalTrials.gov public record
Updated Dec 19, 2020 · Synced Oct 1, 2026, 10:53 PM 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, 10:53 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 1, 2026, 10:53 PM 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, 10:53 PM EDT
Completed Phase 2 Interventional Results available

BI 671800 in Asthmatic Patients on Inhaled Corticosteroids

NCT01103349
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated May 31, 2022 · Synced Oct 1, 2026, 10:53 PM 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, 10:53 PM EDT
Completed Phase 4 Interventional

Single-Center, Double-Blind, Randomized , Parallel Study Comparing Onset of Action, Efficacy & Safety of a Single-Dose of Fexofenadine HCl 180 mg vs Montelukast Na 10 mg & Placebo in Treating Seasonal Allergic Rhinitis Subjects in an Allergen Exposure Unit

NCT00637611
View directory record Official record
Conditions
Seasonal Allergic Rhinitis
Interventions
Fexofenadine HCl
Drug
Lead sponsor
Sanofi
Industry
Eligibility
15 Years and older
Enrollment
1,010 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 12, 2011 · Synced Oct 1, 2026, 10:53 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 1, 2026, 10:53 PM 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 15, 2015 · Synced Oct 1, 2026, 10:53 PM 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, 10:53 PM 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, 10:53 PM 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 17, 2026 · Synced Oct 1, 2026, 10:53 PM 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, 10:53 PM 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 17, 2025 · Synced Oct 1, 2026, 10:53 PM 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, 10:53 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 1, 2026, 10:53 PM EDT
Terminated Phase 4 Interventional Accepts healthy volunteers Results available

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

NCT00119015
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Feb 28, 2014 · Synced Oct 1, 2026, 10:53 PM EDT
Completed Phase 2 Interventional

A Study to Evaluate Efficacy and Safety of ADC3680 in Subjects With Inadequately-Controlled Asthma

NCT01730027
View directory record Official record
Conditions
Asthma
Interventions
ADC3680, Placebo, montelukast
Drug
Lead sponsor
Pulmagen Therapeutics
Industry
Eligibility
18 Years to 50 Years
Enrollment
248 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2014
U.S. locations
35
States / cities
Birmingham, Alabama • Huntington Beach, California • Riverside, California + 32 more
Source: ClinicalTrials.gov public record
Updated Oct 6, 2017 · Synced Oct 1, 2026, 10:53 PM 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, 10:53 PM 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, 10:53 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 1, 2026, 10:53 PM EDT
Active, not recruiting Phase 4 Interventional

Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere's Disease

NCT04815187
View directory record Official record
Conditions
Meniere Disease, Allergic Rhinitis, Vertigo
Interventions
Montelukast, Placebo
Drug
Lead sponsor
House Ear Institute
Other
Eligibility
18 Years and older
Enrollment
39 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
2
States / cities
Los Angeles, California
Source: ClinicalTrials.gov public record
Updated Mar 18, 2025 · Synced Oct 1, 2026, 10:53 PM EDT