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Home › Medications › montelukast

montelukast

3 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials of montelukast

54 trials tracked of montelukast: 39 in phase 3 or 4 and 4 with published results. The most-cited published study has 296 citations.

54Trials tracked
39Phase 3 & 4
0Recruiting
4With published results
Phase distribution
Phase 4 15 Phase 3 24 Phase 2 6 Phase 1 2 Other / NA 7
  1. Phase 3 Individualized Therapy For Asthma in Toddlers Completed · 296 cited
  2. Phase 3 ACTIV-6: COVID-19 Study of Repurposed Medications Completed · 5 cited
  3. Phase 4 Effects of a Orally Inhaled Fluticasone Furoate on Growth Velocity in Prepubertal, Paediatric Subjects With Asthma Over a Year Completed · 2 cited
  4. Phase 3 Effect of Fluticasone Furoate Inhalation Powder on the Hypothalamic-pituitary-adrenocortical Axis of Children Aged 5-11 Years With Asthma Completed · 1 cited
  5. Phase 4 CYP2B6 Genetics and Drug Interactions in Healthy Volunteers Completed
  6. Phase 4 Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing Seasonal Allergic Rhinitis (SAR) Symptoms in Ragweed Sensitive Subjects Completed
Show 44 more trials
  1. Phase 4 Study of Montelukast on Gastrointestinal Tolerability in Patients With Relapsing Forms of Multiple Sclerosis Receiving Tecfidera Completed
  2. Phase 4 A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme Completed
  3. Phase 4 A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children Completed
  4. Phase 4 Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds Completed
  5. Phase 4 The Effects of Montelukast on Smokers With Asthma Completed
  6. Phase 4 Efficacy Study of Montelukast in Atopic Dermatitis Induced by Food Allergens Completed
  7. Phase 4 The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial Completed
  8. Phase 4 The Role of Montelukast in Rhinitis and Sleep Completed
  9. Phase 4 Pediatric ACTION3 (Identify, Treat, Control): Effectiveness of Adding Montelukast in Pediatric Subjects With Uncontrolled Asthma (0476-385) Completed
  10. Phase 4 Effects of Mometasone Furoate Dry Powder Inhaler, Fluticasone Propionate, and Montelukast on Bone Mineral Density in Asthmatics (Study P03418) Completed
  11. Phase 4 Singulair(R) In Asthma And Allergic Rhinitis (0476-383) Completed
  12. Phase 4 Montelukast in Mild Asthmatic Children With Allergic Rhinitis (0476-367) Completed
  13. Phase 3 Montelukast for Early Life Wheezing Completed
  14. Phase 3 ACTIV-6: COVID-19 Study of Repurposed Medications - Arm F (Montelukast) Completed
  15. Phase 3 Does Montelukast Decrease Post Adenotonsillectomy Pain in Children Completed
  16. Phase 3 A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED) Completed
  17. Phase 3 Intermittent and Daily Dosing for Episodic (Periodic) Asthma (0476-302)(COMPLETED) Completed
  18. Phase 3 A Study Comparing Montelukast With Placebo in Children With Seasonal Allergic Rhinitis (0476-219)(COMPLETED) Completed
  19. Phase 3 Montelukast Back to School Asthma Study (0476-340) Completed
  20. Phase 3 Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232) Completed
  21. Phase 3 A Study of an Intravenous Drug in Pediatric Patients With Acute Asthma (0476-301) Completed
  22. Phase 3 Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED) Completed
  23. Phase 3 Study of MK-0476 in Adult Patients With Acute Asthma (0476-334) Completed
  24. Phase 3 The Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients (0476-029) Completed
  25. Phase 3 Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 ) Completed
  26. Phase 3 Study of the Efficacy and Safety of MK-0476 in Japanese Pediatric Participants With Seasonal Allergic Rhinitis (MK-0476-519) Completed
  27. Phase 3 Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246) Completed
  28. Phase 3 Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911) Completed
  29. Phase 3 MK0476 Study in Adult Patients With Acute Asthma (0476-322) Completed
  30. Phase 3 Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED) Completed
  31. Phase 3 The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265) Completed
  32. Phase 3 Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240) Completed
  33. Phase 3 Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235) Completed
  34. Phase 2 BI 671800 in Asthmatic Patients on Inhaled Corticosteroids Completed
  35. Phase 2 Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease Completed
  36. Phase 2 Targeted Therapy of Bronchiolitis Obliterans Syndrome Completed
  37. Phase 2 Montelukast Therapy on Alzheimer's Disease Completed
  38. Phase 2 Roflumilast Plus Montelukast in Adults With Severe Asthma Completed
  39. Phase 2 Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age Completed
  40. Phase 1 A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Montelukast (MK-0476) in Participants With Mild or Moderate Asthma (MK-0476-380 AM3)(COMPLETED) Completed
  41. Phase 1 Drug-Drug Interaction Study: ASP2151 and Montelukast Completed
  42. N/A Study of the Arachidonate 5-Lipoxygenase Enzyme in Affecting the Risk for Coronary Heart Disease Completed
  43. N/A Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma Completed
  44. N/A Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Montelukast vs Fluticasone Completed

Showing the 50 most-cited and recently-updated of 54 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
Montelukast and oral antihistamines improve daytime allergic rhinitis symptoms
Allergy & Immunology Meta-analysis
Montelukast and oral antihistamines improve daytime allergic rhinitis symptoms Combination therapy beats single drug for daytime allergy symptoms
A meta-analysis finds combination therapy significantly improves daytime symptoms in allergic rhinitis, with limited benefits for nighttime …
Combining two common allergy drugs works better for daytime relief than taking just one, but the extra pill might not help you sleep at nigh…
May 5, 2026
Montelukast vs Tiotropium Added to ICS in Children With Asthma
Allergy & Immunology RCT
Montelukast vs Tiotropium Added to ICS in Children With Asthma Asthma Treatment Comparison Shows Mixed Results for Kids
This randomized controlled trial in 152 children aged 6 to 14 years with partly controlled or uncontrolled asthma found no significant diffe…
A small trial found no clear difference between two asthma medicines for children, though one caused rare side effects.
May 1, 2026
Moxibustion plus montelukast for cough variant asthma with wind cold
Allergy & Immunology RCT
Moxibustion plus montelukast for cough variant asthma with wind cold Moxibustion plus montelukast improves cough-variant asthma symptoms and lung function
In 94 patients with cough variant asthma of wind cold attacking the lung, a randomized controlled trial compared modified painless wheat-gra…
Adding a painless moxibustion technique to montelukast improved symptoms, lung function, and long-term control in cough-variant asthma tied …
Apr 22, 2026