Summary
Montelukast Sodium has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Asthma would be drug repurposing rather than first-in-human development. This does not mean it is approved for Asthma. ClinicalTrials.gov lists 8 registered trials linking Montelukast Sodium to Asthma: 8 have completed. The most advanced is Phase 4 (NCT00545324). It plans or enrolled 399 participants. Registration activity spans 2000 to 2016. The literature layer holds 9 publications for this pair: 2 Cochrane reviews, 2 meta-analyses and 5 clinical trial publications. Publication years run from 2016 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Asthma ranks 642 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: 26% of childhood-onset asthma in clinical remission by adulthood; <20% adult-onset achieves sustained remission; 65% long-term remission in mild-moderate vs 16% in severe.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 78.0 (trials 30.0, literature 28.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 8 completed, 0 other |
| Linked publications | 9 (5 clinical trial publications, 2 Cochrane reviews, 2 meta-analyses) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00140881 | A Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children (0476-165) 2000 | completed | Phase 4 | 220 |
| NCT00545324 | First Step With Singulair® Therapy (0476-323) 2002 | completed | Phase 4 | 399 |
| NCT00092092 | Study of Montelukast and Its Effect on Lower Leg Growth in Children With Asthma (MK-0476-254) 2002 | completed | Phase 4 | 71 |
| NCT00442338 | Study of MK-0476 in Adult Patients With Acute Asthma (0476-334) 2007 | completed | Phase 3 | 91 |
| NCT00504946 | Pharmacological Modulations of Allergen-Specific Immunotherapy 2005 | completed | Phase 3 | 85 |
| NCT02720081 | Study of MK-1029 in Participants With Persistent Asthma That Cannot Be Controlled With Montelukast (MK-1029-015) 2016 | completed | Phase 2 | 142 |
| NCT01659905 | Bioequivalency Study of Montelukast Chewable 5 mg Tablets Under Fasted Conditions 2008 | completed | Early Phase 1 | 35 |
| NCT00319488 | Childhood Asthma Research and Education (CARE) Network Trial - Acute Intervention Management Strategies (AIMS) 2004 | completed | Not applicable | 238 |
Published literature
- Clinical trial publication [Effect of modified painless wheat-grain blistering moxibustion on cough variant asthma of wind cold attacking the lung: a randomized controlled trial]Li J, Liu Y, Shao Z et al. · Zhongguo zhen jiu = Chinese acupuncture & moxibustion · 2026 · PMID 41987437
- Meta-analysis Clinical efficacy of montelukast sodium combination therapy for cough variant asthma in children: A meta-analysisYang S, He X, Zhang R · Pediatric pulmonology · 2024 · PMID 38501316
- Clinical trial publication Effect of budesonide combined with montelukast sodium on pulmonary function parameters and immunoglobulin levels in children with bronchial asthmaChu F, Liang L, Chen F · Allergologia et immunopathologia · 2023 · PMID 37422792
- Cochrane review Therapeutic effect of acupuncture combined montelukast sodium on cough variant asthma in children: A protocol for systematic review and meta-analysisZhou X, Zhang Y, Liu L et al. · Medicine · 2021 · PMID 34941045
- Cochrane review Efficacy and safety of montelukast sodium combined with fluticasone in the treatment of adult bronchial asthma: A protocol for systematic review and meta-analysisLuo H, Han H, Liu X et al. · Medicine · 2020 · PMID 33350727
- Clinical trial publication Efficacy of montelukast sodium chewable tablets combined with inhaled budesonide in treating pediatric asthma and its effect on inflammatory factorsZhang Y, Wang H · Die Pharmazie · 2019 · PMID 31739840
- Clinical trial publication [Clinical effect of fluticasone propionate, montelukast sodium and ketotifen in treatment of cough variant asthma in children]Zhu XH, Tu JW, Dai JH · Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2019 · PMID 31014435
- Clinical trial publication [Micro-invasive embedding combined with montelukast sodium for children cough variant asthma:a randomized controlled trial]Wang X, Liu B, Lu B et al. · Zhongguo zhen jiu = Chinese acupuncture & moxibustion · 2017 · PMID 29231431
- Meta-analysis [Therapeutic effect and safety of montelukast sodium combined with budesonide in children with cough variant asthma: a Meta analysis]Wei Y, Li DS, Liu JJ et al. · Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2016 · PMID 27817773
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Montelukast Sodium approved for Asthma?
Montelukast Sodium has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Asthma would be drug repurposing rather than first-in-human development. This does not mean it is approved for Asthma. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Montelukast Sodium in clinical trials for Asthma?
ClinicalTrials.gov lists 8 registered trials linking Montelukast Sodium to Asthma: 8 have completed. The most advanced is Phase 4 (NCT00545324). It plans or enrolled 399 participants. Registration activity spans 2000 to 2016.
What does the evidence show for Montelukast Sodium in Asthma?
Montelukast Sodium has both completed registered trials and synthesis-level publications linked to Asthma. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.