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ClinicalTrials.gov public records Last synced Sep 30, 2026, 1:29 AM EDT

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Showing 25–48 of 108 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Montelukast Clear all
Completed Phase 2 Interventional Results available

Targeted Therapy of Bronchiolitis Obliterans Syndrome

NCT01307462
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Oct 4, 2017 · Synced Sep 30, 2026, 1:29 AM EDT
Withdrawn Phase 2 Interventional

Controlled Trial on Effect of Montelukast Treatment in Children With Obstructive Sleep Apnea Syndrome

NCT00599534
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Apr 10, 2017 · Synced Sep 30, 2026, 1:29 AM 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 Sep 30, 2026, 1:29 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 Sep 30, 2026, 1:29 AM EDT
Completed No phase listed Observational

Early Detection and Management of Bronchiolitis Obliterans Syndrome Following Pediatric Hematopoietic Stem Cell Transplantation

NCT03072849
View directory record Official record
Conditions
Bronchiolitis Obliterans Syndrome
Interventions
Pulmonary function testing, FAM Therapy
Procedure · Drug
Lead sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Other
Eligibility
6 Years to 18 Years
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2020
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Nov 19, 2024 · Synced Sep 30, 2026, 1:29 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 Sep 30, 2026, 1:29 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 Sep 30, 2026, 1:29 AM EDT
Not yet recruiting Early Phase 1 Interventional

Lipid Mediators & Cancer: Montelukast, SPM, and Almonds

NCT06887673
View directory record Official record
Conditions
Colorectal Cancer, Sarcoma, Brain Tumors, Endometrial Cancer, Ovarian Cancer
Interventions
No Interventions, Sports Pro Resolve 4 g, Double Wood SPM 4 g, 20 California Sweet Almonds, Montelukast 10 Mg Oral Tablet, Montelukast 10 Mg Oral Tablet and SPM 4 g, Cold- Pressed Almond Oil 30 mL
Other · Dietary Supplement · Drug + 1 more
Lead sponsor
University of South Florida
Other
Eligibility
18 Years and older
Enrollment
56 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2026
U.S. locations
2
States / cities
Tampa, Florida
Source: ClinicalTrials.gov public record
Updated Mar 20, 2025 · Synced Sep 30, 2026, 1:29 AM EDT
Completed Early Phase 1 Interventional Accepts healthy volunteers

Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fasted Conditions

NCT01659905
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jan 23, 2018 · Synced Sep 30, 2026, 1:29 AM EDT
Completed Not applicable Interventional

Transporter Mediated Uptake of Montelukast

NCT00513760
View directory record Official record
Conditions
Asthma
Interventions
Grapefruit juice, Orange Juice, Gatorade
Dietary Supplement
Lead sponsor
Nemours Children's Clinic
Other
Eligibility
15 Years to 18 Years
Enrollment
27 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2014
U.S. locations
1
States / cities
Jacksonville, Florida
Source: ClinicalTrials.gov public record
Updated Feb 10, 2025 · Synced Sep 30, 2026, 1:29 AM 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 Sep 30, 2026, 1:29 AM EDT
Terminated Phase 1Phase 2 Interventional Results available

Safety, Pharmacokinetics, and Preliminary Efficacy of Isatuximab in Patients Awaiting Kidney Transplantation

NCT04294459
View directory record Official record
Conditions
Immune System Disorder
Interventions
Isatuximab SAR650984, Acetaminophen (paracetamol) or equivalent, Ranitidine or equivalent, Diphenhydramine or equivalent, Methylprednisolone or equivalent, Montelukast or equivalent
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 70 Years
Enrollment
23 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
4
States / cities
San Francisco, California • Rochester, Minnesota • New York, New York + 1 more
Source: ClinicalTrials.gov public record
Updated Sep 17, 2025 · Synced Sep 30, 2026, 1:29 AM 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 Sep 30, 2026, 1:29 AM EDT
Completed Phase 4 Interventional Results available

A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme

NCT06019728
View directory record Official record
Conditions
Fabry's Disease
Interventions
AGALSIDASE BETA (GZ419828), Acetaminophen, Diphenhydramine, Dexamethasone, Montelukast, Loratadine, Cetirizine, Fexofenadine
Drug
Lead sponsor
Sanofi
Industry
Eligibility
2 Years to 65 Years
Enrollment
8 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
5
States / cities
Santa Monica, California • Atlanta, Georgia • Grand Rapids, Michigan + 2 more
Source: ClinicalTrials.gov public record
Updated Oct 21, 2025 · Synced Sep 30, 2026, 1:29 AM EDT
Terminated Phase 1Phase 2 Interventional Results available

Sym013 (Pan-HER) in Patients With Advanced Epithelial Malignancies

NCT02906670
View directory record Official record
Conditions
Oncology
Interventions
Sym013
Drug
Lead sponsor
Symphogen A/S
Industry
Eligibility
18 Years and older
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2019
U.S. locations
3
States / cities
Nashville, Tennessee • San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Aug 28, 2020 · Synced Sep 30, 2026, 1:29 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants

NCT05852769
View directory record Official record
Conditions
Healthy Volunteers
Interventions
BMS-986196, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, Pravastatin
Drug
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
18 Years to 55 Years
Enrollment
18 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023
U.S. locations
1
States / cities
Millcreek, Utah
Source: ClinicalTrials.gov public record
Updated Sep 26, 2023 · Synced Sep 30, 2026, 1:29 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study on Effects of BMS-955176 on the Pharmacokinetics of Probe Substrates

NCT02578277
View directory record Official record
Conditions
HIV Infections
Interventions
CYP and transporter probe substrates, BMS-955176, BMS-955176 plus CYP and transporter probe substrates
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years to 50 Years
Enrollment
59 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015
U.S. locations
1
States / cities
Austin, Texas
Source: ClinicalTrials.gov public record
Updated Jul 13, 2018 · Synced Sep 30, 2026, 1:29 AM EDT
Completed Phase 2 Interventional Results available

Montelukast Therapy on Alzheimer's Disease

NCT03991988
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Mar 7, 2024 · Synced Sep 30, 2026, 1:29 AM EDT
Completed Not applicable Interventional

Childhood Asthma Research and Education (CARE) Network Trial - Acute Intervention Management Strategies (AIMS)

NCT00319488
View directory record Official record
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
Source: ClinicalTrials.gov public record
Updated Jul 29, 2016 · Synced Sep 30, 2026, 1:29 AM 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 Sep 30, 2026, 1:29 AM 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 Sep 30, 2026, 1:29 AM EDT
Completed Not applicable Interventional Accepts healthy volunteers

Airborne Ultrafine and Fine Particulate Matter: A Cause for Endothelial Dysfunction in Man?

NCT00814281
View directory record Official record
Conditions
Airway Inflammation
Interventions
placebo, Montelukast
Other · Drug
Lead sponsor
Marywood University
Other
Eligibility
18 Years to 30 Years · Male only
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2007 – 2009
U.S. locations
1
States / cities
Scranton, Pennsylvania
Source: ClinicalTrials.gov public record
Updated May 21, 2009 · Synced Sep 30, 2026, 1:29 AM EDT
Completed Phase 4 Interventional Results available

Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens

NCT00557284
View directory record Official record
Conditions
Atopic Dermatitis
Interventions
Montelukast, Placebo
Drug
Lead sponsor
1st Allergy & Clinical Research Center
Other
Eligibility
1 Year to 8 Years
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2009
U.S. locations
2
States / cities
Centennial, Colorado • Thornton, Colorado
Source: ClinicalTrials.gov public record
Updated Apr 21, 2015 · Synced Sep 30, 2026, 1:29 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 Sep 30, 2026, 1:29 AM EDT