Montelukast
| Evidence Level: L2 | Predicted Indications: 2 |
Table of Contents
Montelukast: Bronchitis
One-Sentence Summary
Montelukast is a leukotriene receptor antagonist originally used for allergic rhinitis, vasomotor rhinitis, and allergic and intrinsic asthma. The TxGNN model predicts it may be effective for bronchitis, a label that in the supporting trials mostly maps to bronchiolitis and bronchiolitis obliterans syndrome. There are 17 clinical trials and 20 publications on this prediction, but the results are mixed and no clear efficacy has been established.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Bronchitis |
| TxGNN Prediction Score | 0.9995 |
| Evidence Level | L2 |
| India Market Status | Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data |
| Number of Listed Products | at least 20 |
| Recommended Decision | Hold (research question only) |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on known pharmacology, montelukast is a selective cysteinyl leukotriene receptor 1 (CysLT1) antagonist. Cysteinyl leukotrienes drive bronchoconstriction, mucus secretion, airway oedema and eosinophil recruitment. These processes also occur in virus-induced bronchiolitis and post-bronchiolitis wheeze, which gives the prediction a plausible mechanistic basis.
In transplant-related bronchiolitis obliterans, leukotriene pathways are thought to contribute to fibro-obliterative airway remodelling. This is supported by rat model data (PMID 28545478).
The “bronchitis” label should be read with caution. Most trials found for it concern bronchiolitis (an infant viral illness) and bronchiolitis obliterans syndrome (a transplant complication), which are distinct entities. A few concern non-asthmatic eosinophilic bronchitis and recurrent obstructive bronchitis. The evidence is heterogeneous and mixed in outcome, and the systematic review of post-bronchiolitis wheeze (PMID 24118637) does not establish clear efficacy.
Clinical Trial Evidence
The 10 most relevant trials (of 17 identified) are listed below.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT00076973 | Phase 3 | Completed | 1125 | Two doses of montelukast vs placebo for respiratory symptoms of RSV bronchiolitis in children aged 3-24 months |
| NCT01370187 | N/A | Completed | 146 | Montelukast for acute bronchiolitis and post-bronchiolitis wheeze in infants aged 3-12 months |
| NCT00863317 | N/A | Completed | 141 | Randomised, double-blind, placebo-controlled trial of daily montelukast on illness duration in first-time viral bronchiolitis |
| NCT00524693 | N/A | Completed | 51 | Double-blind placebo-controlled trial in acute RSV bronchiolitis, with cytokine profiles |
| NCT04613180 | Phase 4 | Unknown | 100 | Montelukast for treatment and prevention of recurrent obstructive bronchitis in children aged 1-7 years |
| NCT01121016 | Phase 4 | Unknown | 63 | Add-on montelukast to inhaled budesonide in nonasthmatic eosinophilic bronchitis (cough severity) |
| NCT00656058 | Phase 2 | Completed | 25 | Single-arm study of montelukast for bronchiolitis obliterans after stem cell transplantation |
| NCT01211509 | Phase 4 | Completed | 30 | Randomised, placebo-controlled trial of montelukast for bronchiolitis obliterans syndrome after lung transplantation |
| NCT01307462 | Phase 2 | Completed | 36 | Fluticasone + azithromycin + montelukast combination for bronchiolitis obliterans after stem cell transplant (montelukast effect cannot be isolated) |
| NCT00394160 | Phase 2 | Completed | 12 | Safety and plasma concentration study of montelukast granules in infants aged 1-3 months with bronchiolitis |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 25773054 | 2015 | Systematic review (Cochrane) | Cochrane Database Syst Rev | Leukotriene inhibitors such as montelukast for bronchiolitis in infants and young children |
| 24118637 | 2014 | Systematic review | Pediatr Allergy Immunol | Montelukast for preventing post-bronchiolitis wheezing; does not establish clear efficacy |
| 38485149 | 2024 | Guideline | Eur Respir J | ERS/EBMT guidelines on treatment of pulmonary chronic GVHD in adults |
| 38504551 | 2024 | Review | Ther Adv Respir Dis | Therapeutic potential and possible mechanisms of montelukast in bronchiolitis obliterans syndrome after lung and stem cell transplantation |
| 28662986 | 2017 | Systematic review | J Heart Lung Transplant | Therapy options for chronic lung allograft dysfunction-BOS after first-line immunosuppression |
| 29704475 | 2018 | Expert panel report | Chest | CHEST report on chronic cough after acute viral bronchiolitis in children |
| 25563311 | 2015 | Clinical study | Chin Med J | Add-on montelukast to budesonide in nonasthmatic eosinophilic bronchitis: effects on airway inflammation, cough and quality of life |
| 28545478 | 2017 | Animal study | J Cardiothorac Surg | LTB4 and montelukast in transplantation-related bronchiolitis obliterans in rats |
| 30038355 | 2019 | Review | Bone Marrow Transplant | Diagnostic and therapeutic challenges in BOS after transplantation |
| 14766663 | 2004 | Commentary | Am J Respir Crit Care Med | Montelukast in RSV bronchiolitis |
India Market Information
There are 20 valid single-ingredient registrations. The records contain no approved-indication text. Five main authorisations are listed below.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Registration No. 215692 | Telekast 4 Chewable Tablet (Lupin Ltd) | Strip of 10 chewable tablets | Not recorded |
| Registration No. 143469 | Montelast 5mg Tablet (Cadila Pharmaceuticals Ltd) | Strip of 10 tablets | Not recorded |
| Registration No. 146623 | Monteshil 5mg Orally Disintegrating Strip (Shilpa Medicare Ltd) | Box of 10 disintegrating strips | Not recorded |
| Registration No. 190091 | Remont 4mg Tablet DT (Richfield India Pharmaceuticals Pvt Ltd) | Strip of 10 dispersible tablets | Not recorded |
| Registration No. 237498 | Vrikast 10mg Tablet (Vrinda Life) | Strip of 10 tablets | Not recorded |
Many other registrations are fixed-dose combinations containing fexofenadine (for example Fexoreg M and Montecas FX) or other combinations. Oral suspension and prolonged-release tablet forms are also registered.
Safety Considerations
- Neuropsychiatric events: Systematic review and cohort data (PMIDs 37758273, 36948487, 39836401) examine neuropsychiatric adverse events with montelukast. The US FDA added a boxed warning on these risks in 2020. Risk communication and monitoring are needed, particularly in children.
- Disease associations in the knowledge graph (not label text): anxiety disorder, neurotic disorder, dysthymic disorder, anxiety, hypereosinophilic syndrome and cutaneous vasculitis.
- Drug interactions: 470 interactions were recorded. The moderate-level ones include dexamethasone, metronidazole, miconazole, nateglinide, nitisinone and troglitazone. Further entries such as pantoprazole, omeprazole, metformin, glimepiride and morphine have an unknown severity level.
Please refer to the package insert for full warnings and contraindications.
Conclusion and Next Steps
Decision: Hold (research question only)
Rationale: Several randomised trials in infant bronchiolitis exist, including a large Phase 3 trial, but the available systematic reviews do not show clear benefit. The “bronchitis” label also merges distinct conditions (viral bronchiolitis, transplant-related bronchiolitis obliterans and eosinophilic bronchitis), and the safety profile includes neuropsychiatric concerns, particularly in children.
To proceed, the following is needed:
- A precise definition of the target condition, with separate assessment of viral bronchiolitis, bronchiolitis obliterans syndrome and eosinophilic bronchitis
- Review of the results of the large Phase 3 RSV bronchiolitis trial (NCT00076973) and the Cochrane review (PMID 25773054)
- Mechanism of action data and the India package insert warnings and contraindications
- A neuropsychiatric safety monitoring plan, especially for paediatric use
Other Predicted Indications (Brief Note)
- Atopic eczema (score 0.9981, L1): Three Phase 4 trials exist, but the Cochrane review of leukotriene receptor antagonists for eczema (PMID 30343498) did not find convincing benefit. The signal is inconsistent.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.