Montelukast
| Evidence Level: L2 | Predicted Indications: 2 |
Table of Contents
Montelukast: Bronchitis
One-Sentence Summary
Montelukast is an oral leukotriene receptor antagonist that is marketed in Australia. The TxGNN model predicts it may be useful for bronchitis, with a prediction score of 0.9995. The data compiled for this report include 17 registered clinical trials and 20 publications. Only some of these study bronchitis directly, and many address related conditions such as bronchiolitis.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Bronchitis |
| TxGNN Prediction Score | 0.9995 |
| Evidence Level | L2 |
| Australia Market Status | Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data |
| Number of PBS Items | 1 (valid: 1) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism of action data are not available in the data compiled for this report. Montelukast belongs to the leukotriene receptor antagonist class. These drugs block the cysteinyl leukotriene pathway, which drives airway inflammation.
Several of the registered studies are built on this inflammatory link. For example, the RSV bronchiolitis trial NCT00524693 notes that cysteinyl-leukotriene levels are raised in that illness. The trials in non-asthmatic eosinophilic bronchitis test whether adding montelukast to inhaled budesonide improves cough and reduces airway eosinophilia.
The evidence is mixed in design. Small controlled trials address eosinophilic bronchitis and recurrent obstructive bronchitis in children. Larger trials address bronchiolitis in infants, and the registry summaries do not state their results. The prediction is therefore plausible, but the benefit has not been established.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrolment | Key Findings |
|---|---|---|---|---|
| NCT01121016 | Phase 4 | Unknown | 63 | Randomised, double-blind, placebo-controlled trial of add-on montelukast to inhaled budesonide in non-asthmatic eosinophilic bronchitis; primary endpoint is cough severity. |
| NCT04613180 | Phase 4 | Unknown | 100 | Effectiveness of montelukast in treating and preventing recurrent obstructive bronchitis in children aged 1 to 7 years. |
| NCT00076973 | Phase 3 | Completed | 1125 | Randomised, double-blind trial of two doses of montelukast vs placebo for respiratory symptoms of RSV bronchiolitis in children aged 3 to 24 months. |
| NCT00863317 | Not applicable | Completed | 141 | Randomised, double-blind, placebo-controlled trial of daily montelukast on the duration of illness in infants with first-time viral bronchiolitis. |
| NCT01370187 | Not applicable | Completed | 146 | Montelukast in acute bronchiolitis and post-bronchiolitis viral-induced wheezing in infants aged 3 to 12 months. |
| NCT00524693 | Not applicable | Completed | 51 | Double-blind, placebo-controlled trial of montelukast on clinical progress and cytokine profiles in acute RSV bronchiolitis. |
| NCT00394160 | Phase 2 | Completed | 12 | Safety, tolerability and plasma concentrations of montelukast granules in children aged 1 to 3 months with bronchiolitis. |
| NCT00394069 | Phase 2 | Completed | 14 | Safety, tolerability and plasma concentrations of montelukast granules in children aged 3 to 6 months with bronchiolitis. |
| NCT00656058 | Phase 2 | Completed | 25 | Montelukast for bronchiolitis obliterans after stem cell transplantation in children and adults. |
| NCT01211509 | Phase 4 | Completed | 30 | Randomised, double-blind, placebo-controlled trial of montelukast for bronchiolitis obliterans syndrome after lung transplantation. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 25563311 | 2015 | Clinical study | Chinese Medical Journal | Compared montelukast plus budesonide with budesonide alone in non-asthmatic eosinophilic bronchitis, looking at airway eosinophilia, cough and quality of life. |
| 25773054 | 2015 | Systematic review (Cochrane) | Cochrane Database of Systematic Reviews | Reviews leukotriene inhibitors such as montelukast in infants and young children with bronchiolitis. |
| 24118637 | 2014 | Systematic review | Pediatric Allergy and Immunology | Reviews montelukast for preventing wheezing after bronchiolitis, which often follows RSV infection. |
| 29704475 | 2018 | Expert panel report | Chest | Systematic reviews on treatments for chronic cough after acute viral bronchiolitis in children. |
| 40702225 | 2025 | Review | Lung | Evidence that mast cells regulate cough hypersensitivity in eosinophilic bronchitis. |
| 14766663 | 2004 | Commentary | American Journal of Respiratory and Critical Care Medicine | Commentary on montelukast in RSV bronchiolitis; no abstract available. |
| 38504551 | 2024 | Review | Therapeutic Advances in Respiratory Disease | Reviews the therapeutic potential of montelukast in bronchiolitis obliterans syndrome after lung and stem cell transplantation. |
| 38485149 | 2024 | Guideline | European Respiratory Journal | ERS/EBMT clinical practice guidelines on treating pulmonary chronic graft-versus-host disease in adults. |
| 40926299 | 2025 | Consensus statement | British Journal of Haematology | Taiwan consensus on diagnosing, monitoring and managing pulmonary chronic graft-versus-host disease. |
| 28545478 | 2017 | Preclinical (animal) | Journal of Cardiothoracic Surgery | Role of leukotriene B4 and montelukast in transplantation-related bronchiolitis obliterans in rats. |
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 14526M | Montelukast Sandoz 4 | Chewable tablet, 4 mg (as sodium), oral | Not stated in the data compiled |
The one single-ingredient licence listed is valid, and the drug is marketed in Australia. The only dosage form recorded is oral.
Safety Considerations
Drug Interactions: The interaction query returned 100 interacting drugs. The following are classified as moderate:
- Dexamethasone
- Metronidazole
- Miconazole
- Nateglinide
- Nitisinone
- Troglitazone
Many other interactions are listed with an unknown severity level. Examples are pantoprazole, omeprazole, lansoprazole, metformin, glimepiride, doxycycline and morphine.
Please refer to the TGA-approved Product Information (PI) for warnings and contraindications.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: The evidence level is L2. Small controlled trials of montelukast exist in non-asthmatic eosinophilic bronchitis and recurrent obstructive bronchitis. The larger bronchiolitis trials address a related condition, and their results are not stated in the data compiled for this report. The model score is very high (0.9995), but the clinical benefit for bronchitis remains unproven.
To proceed, the following is needed:
- Review of the published results of the eosinophilic bronchitis and recurrent obstructive bronchitis trials (NCT01121016, NCT04613180), and of the Cochrane conclusions, to confirm whether any benefit is shown
- Mechanism of action data and a clear definition of the target bronchitis population (for example eosinophilic or paediatric)
- TGA Product Information warnings and contraindications, which are not in the compiled data
- A review of the moderate-severity interactions listed above before any use in a new population
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.