Clinical trials: Montelukast
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
Perennial Allergic Rhinitis
Study of the Safety and Pharmacokinetics of Montelukast (MK-0476) in the Treatment of Japanese Pediatric Participants With Perennial Allergic Rhinitis (MK-0476-520)
This study will evaluate the safety and pharmacokinetics of montelukast (MK-0476) in the treatment of Japanese pediatric participants with perennial allergic rhinitis (PAR).
- Trial name
- NCT01852812
- Testing
- Montelukast Oral Granules (OG), Montelukast Chewable Tablets (CT)
- Volunteers
- 87 people
- Sponsor
- Organon and Co
Chronic Asthma
The Safety and Effectiveness of MK0476 (Montelukast) in Patients With Chronic Asthma (0476-388)
This study will test the safety and effectiveness of a range of doses of MK0476 (montelukast) compared to placebo on improved lung function in patients with chronic asthma.
- Trial name
- NCT00739297
- Testing
- Comparator: montelukast
- Volunteers
- 68 people
- Sponsor
- Organon and Co
Asthma
BI 671800 in Asthmatic Patients on Inhaled Corticosteroids
This is a 6 week study to assess the effect of BI 671800 in patients with asthma. It is a double blind, parallel arm trial testing the safety and efficacy of BI 671800. The main objective is to assess the effect on lung function.
- Trial name
- NCT01103349
- Testing
- BI 671800, Montelukast
- Where
- 53 sites in United States, Austria and 7 more
- Volunteers
- 243 people
- Sponsor
- Boehringer Ingelheim
Asthma
Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age
The primary objective of this study is to evaluate the efficacy and safety of adding GSK2190915 100mg, GSK2190915 300mg or placebo tablets administered once daily to fluticasone propionate 100mcg inhalation administered twice…
- Trial name
- NCT01156792
- Testing
- FP 100, GSK2190915 100, GSK2190915 300
- Where
- 32 sites in United States
- Volunteers
- 162 people
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fed Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
- Trial name
- NCT01671722
- Testing
- Montelukast sodium
- Where
- India
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Asthma
To Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy (0476-366)
To evaluate the changes in proinflammatory markers (ltd4 in urine) and eosinophil from peripheral blood after newly initiated montelukast therapy.
- Trial name
- NCT00398151
- Testing
- MK0476, montelukast sodium / Duration of Treatment: 12 Weeks
- Volunteers
- 58 people
- Sponsor
- Organon and Co
Asthma
TEAM (Trial on Efficacy and Quality of Life Among Asthmatic Patient With Montelukast)
To compare the quality of Life using AQLQ (s) questionnaire after 4 weeks of Montelukast.
- Trial name
- TEAM (NCT03096327)
- Testing
- Montelukast
- Where
- Pakistan
- Volunteers
- 180 people
- Sponsor
- PharmEvo Pvt Ltd
Perennial Allergic Rhinitis
Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)
This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an active control.
- Trial name
- NCT00974571
- Testing
- montelukast sodium, Comparator: cetirizine
- Volunteers
- 1,365 people
- Sponsor
- Organon and Co
Asthma
Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily
To evaluate the efficacy, dose response and safety of four doses of GSK2190915 in tablet form (10mg, 30mg, 100mg and 300mg) administered once daily, over 8 weeks compared with placebo in adolescent and adult subjects (12 years of…
- Trial name
- NCT01147744
- Testing
- Fluticasone Propionate 100mcg via ACCUHALER/DISKUS, GSK2190915 100mg, GSK2190915 10mg
- Where
- 84 sites in United States, Bulgaria and 4 more
- Volunteers
- 700 people
- Sponsor
- GlaxoSmithKline
Asthma
SINGULAIR (R) as Complementary Therapy to Fixed Association Regimen (0476-363)
The purpose of this study is to assess the treatment effect of montelukast 10mg on the primary endpoint of Asthma Control Questionnaire(ACQ), over a 8-week period, in persistent asthma patients with or without allergic rhinitis.
- Trial name
- STAR (NCT00445107)
- Testing
- MK0476, montelukast sodium / Duration of Treatment: 8 Weeks
- Volunteers
- 198 people
- Sponsor
- Organon and Co
Bronchiolitis
An Investigational Drug Study to Treat Respiratory Symptoms Associated With Respiratory Syncytial Virus (RSV) Bronchiolitis (0476-272)
The purpose of this study is to look at whether an investigational drug can treat the breathing symptoms of RSV bronchiolitis in children 3 to 24 months of age.
- Trial name
- NCT00076973
- Testing
- montelukast sodium
- Volunteers
- 1,125 people
- Sponsor
- Organon and Co
Asthma
The Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients (0476-029)
This study will investigate the additive effect of montelukast (MK0476) taken along with inhaled beclomethasone versus inhaled beclomethasone alone.
- Trial name
- NCT00911547
- Testing
- montelukast sodium, beclomethasone
- Volunteers
- 642 people
- Sponsor
- Organon and Co
Asthma, Bronchial, Rhinitis, Allergic, Perennial
Study of MK0476 (Montelukast Sodium) and Effects on Asthma and Nasal Symptoms Upon Exposure to Cats (0476-256)
The purpose of this study is to determine the protective effect of an approved medication on asthma and allergic rhinitis (inflammation of the mucous membrane of the nose) upon exposure to cats.
- Trial name
- NCT00092105
- Testing
- MK0476, montelukast sodium
- Volunteers
- 58 people
- Sponsor
- Organon and Co
Perennial Allergic Rhinitis
Efficacy and Safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) Patients
The purpose of this study is to demonstrate that the efficacy of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride is superior to that of Levocetirizine and Montelukast monotherapies and to compare the safety and…
- Trial name
- NCT01640535
- Testing
- Montelukast + Levocetirizine, Levocetirizine, Montelukast
- Where
- South Korea
- Volunteers
- 283 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Asthma
Study of MK-1029 in Participants With Persistent Asthma That Cannot Be Controlled With Montelukast (MK-1029-015)
The purpose of this trial is to compare the safety, tolerability, and efficacy of adding MK-1029 to montelukast in adults with persistent asthma that is uncontrolled while receiving montelukast alone.
- Trial name
- NCT02720081
- Testing
- MK-1029 150 mg, Montelukast 10 mg, Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation
- Volunteers
- 142 people
- Sponsor
- Merck Sharp & Dohme LLC
Asthma
Linear Growth Study (0476-097)(COMPLETED)
The purpose of this study is to compare the effect of montelukast with placebo and beclomethasone on the average rate of linear growth over a period of 56 weeks in children with mild asthma.
- Trial name
- NCT00395408
- Testing
- MK0476, montelukast sodium / Duration of Treatment : 56 Weeks, Comparator : beclomethasone dipropionate / Duration of Treatment : 56 Weeks
- Volunteers
- 360 people
- Sponsor
- Organon and Co
Seasonal Allergic Rhinitis
Effect of Loratadine/Montelukast Combination on Congestion in SAR Patients Exposed to Pollen in an EEU (Study P04822)
This is study of LMC, phenylephrine, and placebo in subjects with SAR. There are three visits: At Visit 1, subjects will be evaluated for participation and, if they qualify, will attend Visit 2 for priming.
- Trial name
- NCT00423995
- Testing
- Loratadine/montelukast combination
- Volunteers
- 379 people
- Sponsor
- Organon and Co
Seasonal Allergic Rhinitis
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
The primary objective of this study is to determine the efficacy and onsets of action of single-dose fexofenadine hydrochloride 180 mg and montelukast sodium 10 mg relative to placebo.
- Trial name
- NCT00637611
- Testing
- Fexofenadine HCl
- Where
- United States
- Volunteers
- 1,010 people
- Sponsor
- Sanofi
Seasonal Allergic Rhinoconjunctivitis, Asthma
Efficacy of Co-administration of Bilastine and Montelukast in Patients With SARC and Asthma
The purpose of this study is to compare concomitant administration of Montelukast and Bilastine to Montelukast and Bilastine monotherapies in patients with SARC and asthma
- Trial name
- SKY (NCT02761252)
- Testing
- Bilastine 20mg, Montelukast 10mg
- Where
- 32 sites in Croatia, Czechia and 6 more
- Volunteers
- 454 people
- Sponsor
- Menarini International Operations Luxembourg SA