Independent directory Public ClinicalTrials.gov records United States
Clinical Trials Finder
Objective public record navigation
Search Results

Search by objective public record fields.

Search by query text, NCT ID, condition, intervention, sponsor, city, state, recruitment status, phase, study type, healthy volunteer eligibility, sex, or age. Results come from ClinicalTrials.gov. When the live registry is unavailable, a clearly labeled stored copy may be shown.

Clear filters

These results were retrieved from the live ClinicalTrials.gov registry. Filters and sort order apply to this result list.

ClinicalTrials.gov public records Last synced Oct 4, 2026, 7:51 PM EDT

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

Showing 25–48 of 55 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Montelukast Placebo Clear all
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 4, 2026, 7:51 PM EDT
Withdrawn Not applicable Interventional Accepts healthy volunteers

Effects of Montelukast on Occult Exercise-Induced Bronchospasm in Athletes

NCT00375232
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jan 7, 2016 · Synced Oct 4, 2026, 7:51 PM EDT
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 4, 2026, 7:51 PM EDT
Withdrawn Not applicable Interventional Accepts healthy volunteers

Adolescent and Adult Subjects With Asthma and Seasonal Allergic Rhinitis Receiving Advair Diskus or Placebo

NCT00385463
View directory record Official record
Conditions
Asthma, Seasonal Allergic Rhinitis
Interventions
Adding Advair Diskus 100/50mcg (FSC) BID and Singulair 10mg is added to placebo Diskus BID
Drug
Lead sponsor
Creighton University
Other
Eligibility
15 Years to 75 Years
Healthy volunteers
Accepts healthy volunteers
Timeline
2006 – 2007
U.S. locations
1
States / cities
Omaha, Nebraska
Source: ClinicalTrials.gov public record
Updated Jun 16, 2016 · Synced Oct 4, 2026, 7:51 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 4, 2026, 7:51 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 4, 2026, 7:51 PM EDT
Completed Not applicable Interventional Results available

Study of the Arachidonate 5-Lipoxygenase Enzyme in Affecting the Risk for Coronary Heart Disease

NCT00379808
View directory record Official record
Conditions
Coronary Heart Disease
Interventions
montelukast, Placebo
Drug
Lead sponsor
University of Florida
Other
Eligibility
18 Years and older
Enrollment
22 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2009
U.S. locations
1
States / cities
Gainesville, Florida
Source: ClinicalTrials.gov public record
Updated Jul 23, 2012 · Synced Oct 4, 2026, 7:51 PM 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 4, 2026, 7:51 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 4, 2026, 7:51 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 4, 2026, 7:51 PM EDT
Recruiting Phase 1Phase 2 Interventional

PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysplasia

NCT07101640
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jul 14, 2026 · Synced Oct 4, 2026, 7:51 PM EDT
Completed Phase 4 Interventional

Study Of Patients With Allergic Rhinitis And Asthma

NCT00296530
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Oct 28, 2016 · Synced Oct 4, 2026, 7:51 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 4, 2026, 7:51 PM 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 4, 2026, 7:51 PM EDT
Completed Phase 3 Interventional Results available

ACTIV-6: COVID-19 Study of Repurposed Medications - Arm F (Montelukast)

NCT05894577
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jan 17, 2025 · Synced Oct 4, 2026, 7:51 PM 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 4, 2026, 7:51 PM EDT
Completed Phase 4 Interventional

Asthma in the Elderly: The Effect of Montelukast

NCT02635334
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Oct 5, 2016 · Synced Oct 4, 2026, 7:51 PM EDT
Completed Not applicable Interventional Results available

Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma

NCT00359073
View directory record Official record
Conditions
Asthma
Interventions
montelukast, placebo
Drug
Lead sponsor
University of Wisconsin, Madison
Other
Eligibility
18 Years to 65 Years
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2006 – 2009
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Mar 13, 2018 · Synced Oct 4, 2026, 7:51 PM EDT
Terminated Phase 4 Interventional Results available

Effect of Montelukast Therapy in Obstructive Sleep Apnea(OSA) Children

NCT01027806
View directory record Official record
Conditions
Obstructive Sleep Apnea
Interventions
Montelukast
Drug
Lead sponsor
University of Chicago
Other
Eligibility
2 Years to 10 Years
Enrollment
64 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010 – 2014
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated May 3, 2019 · Synced Oct 4, 2026, 7:51 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 4, 2026, 7:51 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 4, 2026, 7:51 PM EDT
Completed Phase 1 Interventional

Comparative Effects of Fish Oil Supplementation and a Montelukast on EIB and Airway Inflammation in Asthma

NCT00676468
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Oct 9, 2009 · Synced Oct 4, 2026, 7:51 PM EDT
Recruiting Phase 1 Interventional

Clinical Evaluation of Montelukast in Veterans With Gulf War Illness

NCT05992311
View directory record Official record
Conditions
Gulf War Syndrome
Interventions
Montelukast, Placebo
Drug · Other
Lead sponsor
Baylor College of Medicine
Other
Eligibility
50 Years to 70 Years
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
1
States / cities
Houston, Texas
Source: ClinicalTrials.gov public record
Updated Sep 1, 2026 · Synced Oct 4, 2026, 7:51 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 4, 2026, 7:51 PM EDT