Independent directory Public ClinicalTrials.gov records United States
Clear filters
ClinicalTrials.gov public records Last synced Sep 2, 2026, 2:03 AM EDT

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

Showing 1–24 of 106 matching trials from the live ClinicalTrials.gov search.
Local D1 index available.
Completed Phase 2Phase 3 Interventional Results available

Montelukast for Early Life Wheezing

NCT00115297
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
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
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
Terminated Phase 3 Interventional Results available

Targeting Leukotrienes in Kidney Disease

NCT05362474
Conditions
Diabetic Kidney Disease
Interventions
Montelukast
Drug
Lead sponsor
University of Colorado, Denver
Other
Eligibility
30 Years to 70 Years
Enrollment
6 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
1
States / cities
Aurora, Colorado
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
Conditions
Exercise Induced Bronchospasm
Interventions
montelukast vs pretreatment with albuterol, montelukast
Drug
Lead sponsor
University of New Mexico
Other
Eligibility
7 Years to 17 Years
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2005 – 2007
U.S. locations
1
States / cities
Albuquerque, New Mexico
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
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
Completed Phase 2 Interventional Results available

Targeted Therapy of Bronchiolitis Obliterans Syndrome

NCT01307462
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
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
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
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
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
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
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
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
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
Conditions
Asthma
Interventions
Montelukast, Singulair
Drug
Lead sponsor
Roxane Laboratories
Industry
Eligibility
18 Years to 45 Years
Enrollment
36 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008
U.S. locations
1
States / cities
Fargo, North Dakota
Conditions
Asthma, COPD
Interventions
montelukast sodium
Drug
Lead sponsor
Kaiser Permanente
Other
Eligibility
50 Years and older
Enrollment
200 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1999 – 2002
U.S. locations
1
States / cities
Portland, Oregon
Completed Phase 1 Interventional Accepts healthy volunteers

A Phase 1 Drug-drug Interaction Study in Healthy Volunteers

NCT02227173
Conditions
Drug-drug Interaction Study
Interventions
BMS-986020, Montelukast, Flurbiprofen, Digoxin
Drug
Lead sponsor
Bristol-Myers Squibb
Industry
Eligibility
18 Years to 50 Years
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
1
States / cities
San Antonio, Texas
Conditions
Plasma Cell Myeloma Refractory
Interventions
Isatuximab SC-OBDS, Montelukast, Dexamethasone, Acetaminophen, Diphenhydramine, Methylprednisolone, Carfilzomib
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years and older
Enrollment
64 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
34
States / cities
Phoenix, Arizona • Los Angeles, California • West Hollywood, California + 29 more
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
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
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