Clinical trials: Montelukast
Respiratory Disorders, Asthma and Rhinitis
Bioequivalence of GW483100 10 Milligram (mg) Tablets in Healthy Subjects Under Fasting Conditions
This study is conducted to determine whether the test product (GW483100 10 mg containing montelukast sodium equivalent to 10 mg of montelukast) is bioequivalent to the reference montelukast sodium 10 mg tablets (innovator…
- Trial name
- NCT02658422
- Testing
- Test Montelukast, Reference Montelukast
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Allergic Rhinitis
A Study to Evaluate the Safety of Combination Montelukast/Loratadine in Mexican Participants With Allergic Rhinitis (MK-0476A-484)
The purpose of this study is to assess the safety and tolerability of montelukast 10 mg/loratadine 10 mg versus placebo in Mexican participants with allergic rhinitis.
- Trial name
- NCT01673620
- Testing
- Montelukast 10 mg/loratadine 10 mg
- Volunteers
- 69 people
- Sponsor
- Organon and Co
Asthma
Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma
Explorative comparison of montelukast with inhaled steroids (fluticasone) to estimate responder profiles, in terms of symptom scores, rescue medication, increase of FEV1, in correlation to presence of allergy, bronchial…
- Trial name
- LOS (NCT00543686)
- Testing
- Montelukast, Fluticasone
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Johann Wolfgang Goethe University Hospital
Bronchial Asthma, Food Allergy
Effects of Montelukast in Asthmatic Children With and Without Food Allergy
To search the effects of montelukast on the airway inflammation including FEV1%, FEV1%/FVC, the provocholine® (methacoline chloride powder for inhalation) challenge tests, the leukotriene levels in the exhaled breath condensate…
- Conditions
- Bronchial Asthma, Food Allergy, Children
- Trial name
- NCT01618929
- Testing
- Montelukast
- Where
- Turkey (Türkiye)
- Volunteers
- 113 people
- Sponsor
- Hacettepe University
HIV Infections
Study on Effects of BMS-955176 on the Pharmacokinetics of Probe Substrates
The purpose of the study is to study the effects of BMS-955176 on the single-dose PK parameters of probe substrates caffeine, metoprolol, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin
- Trial name
- NCT02578277
- Testing
- CYP and transporter probe substrates, BMS-955176, BMS-955176 plus CYP and transporter probe substrates
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Respiratory Disorders
Relative Bioavailability Study of Two Montelukast Sodium (GW483100) 5 Milligrams (mg) Chewable Tablets and One Reference Montelukast Sodium 5 mg Chewable Tablet in Healthy Adult Subjects
This study is designed to estimate the bioavailability of montelukast from the 5 milligrams (mg) montelukast sodium (GW483100) test formulations relative to 5 mg montelukast sodium reference chewable tablets (innovator product).
- Trial name
- NCT02322671
- Testing
- Reference Montelukast, Test 1 Montelukast, Test 2 Montelukast
- Where
- India
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Non Alcoholic Steatohepatitis
Efficacy and Safety of Montelukast in Non Alcoholic Steatohepatitis (NASH)
the current study is to evaluate the efficacy and safety of Montelukast in the treatment of patients with non-alcoholic steatohepatitis (NASH).
- Trial name
- NCT04537780
- Testing
- Montelukast
- Where
- Egypt
- Volunteers
- 44 people
- Sponsor
- Tanta University
Mild Persistent Asthma
Response of FeNO, Small Airway Dysfunction and Lung Heterogeneity to 2-week Montelukast Treatment in Asthmatic Children.
This study aims to identify markers to prove rapid improvement of lung function, airway inflammation and bronchodilator response after 2-week LTRA administration.
- Trial name
- NCT01581710
- Volunteers
- 32 people
- Sponsor
- CHA University
Wheezing
Wheeze and Intermittent Treatment
The clinical aim of this trial is to assess whether intermittent montelukast is an effective treatment strategy in preschool wheeze.
- Trial name
- WAIT (NCT01142505)
- Testing
- Mannitol, Montelukast
- Where
- United Kingdom
- Volunteers
- 1,358 people, healthy volunteers welcome
- Sponsor
- Queen Mary University of London
Asthma
Study of the Effect of Mometasone Furoate/Formoterol (MF/F), Montelukast and Beclomethasone Dipropionate (BDP) on Plasma Cortisol Levels of Children 5-11 Years Old With Persistent Asthma (P05574)
The purpose of this study is to assess the effect of one of five possible study medications used in the treatment of asthma on blood plasma cortisol levels in children aged 5-11 years with persistent asthma.
- Trial name
- NCT01615874
- Testing
- MF/F Metered Dose Inhaler (MDI) 25/5 mcg, MF/F MDI 50/5 mcg, MF/F MDI 100/5 mcg
- Sponsor
- Organon and Co
Erythema Nodosum Leprosum, Leprosy
Montelukast in ENL Reaction
Objective of the trial is to assess the safety and efficacy of Montelukast in treatment of Erythema Nodosum leprosum (ENL) reaction in multibacillary leprosy patients either in combination with prednisolone or alone.
- Trial name
- NCT00406861
- Testing
- montelukast in treatment of ENL reaction
- Where
- Bangladesh
- Volunteers
- 60 people
- Sponsor
- The Leprosy Mission Bangladesh
Asthma
Management of Asthma in School-age Children on Therapy
Asthma affects 1 in 8 children in the UK. Up to half of these are treated with preventative medicine in the form of low-dose steroids using an inhaler.
- Trial name
- MASCOT (NCT01526161)
- Testing
- inhaled fluticasone propionate, salmeterol, Montelukast
- Volunteers
- 229 people
- Sponsor
- Professor Warren Lenney
Ovarian Hyperstimulation Syndrome
Montelukast for Prevention & Treatment of OHSS
montelukast \& dydrgesteron will be given to cases with suspected or proven ovarian hyperstimulation in one group in comparison with dydrogesteron alone in the other group.
- Trial name
- NCT03794037
- Testing
- dydrgesterone 10 mg( tab)/12hs/14 days, montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days
- Where
- Egypt
- Volunteers
- 20 people
- Sponsor
- Benha University
Perennial Allergic Rhinitis
The Role of Montelukast in Rhinitis and Sleep
The hypothesis is that a leukotriene receptor antagonist (LRA), montelukast, will decrease nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep fragmentation in individuals with year round…
- Trial name
- NCT00590772
- Testing
- montelukast
- Volunteers
- 31 people
- Sponsor
- Penn State University
COVID-19 Pneumonia
Effect of Montelukast Therapy on Clinical Course, Pulmonary Function, and Mortality in Patients With COVID-19
'Pandemic' is a medical term that has become a ubiquitous part of the global vocabulary over the last year. Although pandemics have occurred throughout human history, their sociocultural, economic, and psychological impact can…
- Trial name
- NCT05094596
- Testing
- Standart treatment group, Montelukast sodium 10 mg treatment, Montelukast sodium 20 mg treatment
- Where
- Turkey (Türkiye)
- Volunteers
- 180 people
- Sponsor
- Bugra Kerget
Rhinitis, Allergic, Seasonal
Effects of Loratadine/Montelukast vs Pseudoephedrine and Placebo in Patients With Seasonal Allergic Rhinitis (Study P04095) (COMPLETED)
This is a Phase 3, randomized, parallel-group, multicenter, double-dummy, double-blind study with a screening period. Subjects will receive one of the following three treatment groups for 15 days: loratadine 10 mg/montelukast 10…
- Trial name
- NCT00319995
- Testing
- loratadine; montelukast
- Volunteers
- 1,095 people
- Sponsor
- Organon and Co
Premature Birth, Infant, Very Low Birth Weight
The Efficacy and Safety of Montelukast Sodium in the Prevention of Bronchopulmonary Dysplasia
This study is multicentered, prospective, randomized, opened, parallel, intervention study. The aim of this study is to evaluate the efficacy and safety of Montelukast sodium in the prevention of bronchopulmonary dysplasia (BPD)…
- Conditions
- Premature Birth, Infant, Very Low Birth Weight, Bronchopulmonary Dysplasia
- Trial name
- BPD (NCT01717625)
- Testing
- Montelukast
- Where
- South Korea
- Volunteers
- 72 people
- Sponsor
- Ajou University School of Medicine
Acute Bronchiolitis
Evaluating The Role Of Montelukast In Management Of Acute Bronchiolitis
This study aims to evaluate the role of Montelukast in management of acute Bronchiolitis in indoor patient and how this drug shortens the duration of admission and improves symptoms
- Trial name
- NCT07770464
- Testing
- Montelukast
- Where
- Pakistan
- Volunteers
- 60 people
- Sponsor
- Pakistan Institute of Medical Sciences
Healthy Adults
Bioequivalence Study of Montelukast, 5 mg Chewable Tablets (Pharmtechnology LLC, Belarus), and Singulair®, 5 mg Chewable Tablets (Merck Sharp & Dohme B.V., the Netherlands), in Healthy Volunteers Under Fasting Conditions
This is an open-label, randomized, single-center, single-dose, crossover, in two periods and in two sequences comparative study, where each participant is randomly assigned to the reference or the test formulation in each period…
- Trial name
- NCT03898193
- Testing
- Montelukast, Singulair
- Where
- Russia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Multiple Sclerosis
Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera
The primary objective of this study is to evaluate whether montelukast can reduce the severity of gastrointestinal (GI) events, measured by the Gastrointestinal Symptom Rating Scale (GSRS), after oral administration of dimethyl…
- Trial name
- MITIGATE (NCT02410278)
- Testing
- dimethyl fumarate, montelukast
- Where
- 50 sites in United States
- Volunteers
- 102 people
- Sponsor
- Biogen