Independent directory Public ClinicalTrials.gov records United States
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ClinicalTrials.gov public records Last synced Sep 24, 2026, 7:36 AM EDT

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Showing 1–24 of 55 matching trials from the live ClinicalTrials.gov search.
Local D1 index available.
Conditions
Multiple Sclerosis
Interventions
dimethyl fumarate, montelukast, Placebo
Drug
Lead sponsor
Biogen
Industry
Eligibility
18 Years and older
Enrollment
102 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
50
States / cities
Jonesboro, Arkansas • Carmichael, California • La Jolla, California + 46 more
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
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
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
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
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
Terminated Phase 4 Interventional Accepts healthy volunteers Results available

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

NCT00119015
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Completed Phase 1 Interventional Accepts healthy volunteers

Trial of Montelukast in Eosinophilic Esophagitis

NCT00511316
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