Vilanterol
| Evidence Level: L1 | Predicted Indications: 10 |
Table of Contents
Vilanterol: From Inhaled Combination Therapy to Obstructive Lung Disease
One-Sentence Summary
Vilanterol is a long-acting beta2-agonist (LABA) that is already marketed in South Africa as a component of fluticasone furoate/vilanterol and fluticasone furoate/umeclidinium/vilanterol inhalers. The TxGNN model predicts it is effective for obstructive lung disease, and 50 clinical trials and 20 publications are linked to this prediction. This is largely a description of existing COPD and asthma use rather than a new repurposing signal.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | The registered indication text was not captured for the SAHPRA licences. The linked trials show use in COPD and asthma inhaled combinations. |
| Predicted New Indication | Obstructive lung disease |
| TxGNN Prediction Score | 99.97% |
| Evidence Level | L1 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 2 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Vilanterol is a long-acting beta2-adrenergic agonist. It relaxes bronchial smooth muscle and produces bronchodilation. This matches the airflow obstruction seen in COPD and asthma. Detailed mechanism of action data is not available from DrugBank in this Evidence Pack, so this description is based on the known drug class.
The “new” indication is essentially the drug’s established use. Vilanterol is not sold alone in this dataset. It is combined with an inhaled corticosteroid (fluticasone furoate) and/or a long-acting muscarinic antagonist (umeclidinium). The model’s high score therefore probably reflects real, existing therapeutic use. The label status in South Africa should be confirmed before this is treated as a novel signal.
Clinical Trial Evidence
The Evidence Pack contains 50 linked trials. The 10 most relevant are listed below. All test vilanterol-containing combinations, not vilanterol alone. The pack has no ICTRP records, and no SANCTR or PACTR identifiers are recorded.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01313676 | Phase 3 | Completed | 16,568 | FF/VI 100/25 mcg vs placebo on survival in moderate COPD with cardiovascular risk |
| NCT02345161 | Phase 3 | Completed | 1,811 | 24-week double-blind comparison of once-daily FF/UMEC/VI vs twice-daily budesonide/formoterol on lung function and health status |
| NCT02105974 | Phase 3 | Completed | 1,621 | 12-week FF/VI 100/25 mcg vs vilanterol alone, testing the contribution of FF to lung function |
| NCT02729051 | Phase 3 | Completed | 1,055 | 24-week non-inferiority comparison of closed triple therapy (FF/UMEC/VI) vs open triple therapy (FF/VI + UMEC) |
| NCT01316913 | Phase 3 | Completed | 872 | UMEC/VI vs UMEC alone and vs tiotropium over 24 weeks |
| NCT03474081 | Phase 4 | Completed | 800 | 12-week FF/UMEC/VI vs tiotropium on lung function and symptoms |
| NCT01822899 | Phase 3 | Completed | 717 | 12-week UMEC/VI vs fluticasone propionate/salmeterol |
| NCT01323634 | Phase 3 | Completed | 519 | 24-hour lung function (FEV1) of once-daily FF/VI vs twice-daily fluticasone propionate/salmeterol |
| NCT02152605 | Phase 3 | Completed | 498 | 12-week placebo-controlled study of UMEC/VI on quality of life and rescue medication use |
| NCT01336608 | Phase 3 | Completed | 446 | 24-week effect of FF/VI on arterial stiffness in COPD vs placebo and vilanterol |
Literature Evidence
The Evidence Pack contains 20 publications. The 10 most relevant are listed below. The summaries reflect the question or finding stated in the abstract.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 29668352 | 2018 | RCT | N Engl J Med | Once-daily single-inhaler triple therapy vs dual therapy in COPD (IMPACT) |
| 28375647 | 2017 | RCT | Am J Respir Crit Care Med | FULFIL trial of once-daily triple therapy vs dual ICS/LABA therapy in COPD |
| 32918892 | 2021 | RCT | Lancet Respir Med | CAPTAIN: FF/UMEC/VI vs FF/VI in inadequately controlled asthma |
| 32162970 | 2020 | RCT post hoc analysis | Am J Respir Crit Care Med | IMPACT showed a significant reduction in all-cause mortality with FF/UMEC/VI vs UMEC/VI |
| 31281061 | 2019 | RCT post hoc analysis | Lancet Respir Med | Blood eosinophils and response to triple vs dual therapy. IMPACT showed fewer exacerbations with triple therapy. |
| 39696097 | 2024 | Meta-analysis | BMC Pulm Med | UMEC/VI vs other bronchodilators in COPD |
| 35849317 | 2022 | Network meta-analysis | Adv Ther | FF/UMEC/VI vs other triple and dual therapies in COPD |
| 39797646 | 2024 | Cohort | BMJ | Real-world comparison of single-inhaler triple therapies (FF/UMEC/VI vs budesonide/glycopyrrolate/formoterol) |
| 37213116 | 2023 | Cohort | JAMA Intern Med | COPD exacerbations and pneumonia hospitalisations among new users of combination inhalers |
| 28956463 | 2017 | Review | Expert Rev Respir Med | Role of once-daily FF/VI in stable COPD |
South Africa Market Information
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Reg. No. 48/21.5.1/0247 | Revinty Ellipta 92/22 µg | Inhaler | Not captured in the Evidence Pack |
| Reg. No. 52/21.5.1/0177 | Trelegy Ellipta | Inhaler | Not captured in the Evidence Pack |
Essential Medicines List (EML) status is not recorded in the Evidence Pack.
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Multiple large, completed Phase 3 trials and randomised publications support vilanterol-containing inhalers in obstructive lung disease (COPD and asthma), and two products are already marketed in South Africa. However, this is an existing use, not a true repurposing candidate. The other nine TxGNN predictions (ranks 2–10, such as emphysema subtypes, tracheal stenosis and laryngotracheitis) have no supporting evidence or only indirect evidence. They should stay on Hold.
To proceed, the following is needed:
- Download and review the SAHPRA package inserts to confirm the registered indications, warnings and contraindications for both products.
- Obtain mechanism of action data from DrugBank.
- Confirm that the registered indications already cover COPD and asthma before treating this as a novel signal.
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.