Vilanterol
| Evidence Level: L1 | Predicted Indications: 10 |
Table of Contents
Vilanterol: From Chronic Obstructive Pulmonary Disease to Obstructive Lung Disease
One-Sentence Summary
Vilanterol is a long-acting beta2-agonist (LABA) used in fixed-dose inhaler combinations, originally for chronic obstructive pulmonary disease (COPD) and asthma. The TxGNN model predicts it may be effective for obstructive lung disease, with 28 clinical trials and 20 publications compiled for this direction. Because this prediction overlaps closely with the existing COPD and asthma uses, it is better seen as a near-label indication than as true repurposing.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Chronic obstructive pulmonary disease, asthma, bronchitis, pulmonary emphysema (from the knowledge graph; no approved indication text is available for the New Zealand licences) |
| Predicted New Indication | Obstructive lung disease |
| TxGNN Prediction Score | 99.97% |
| Evidence Level | L1 |
| New Zealand Market Status | Cancelled only |
| Number of Authorizations | 3 (all cancelled) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data is not available in the data compiled for this report. Based on known pharmacology, vilanterol is a long-acting beta2-adrenergic agonist. It relaxes airway smooth muscle through cAMP-mediated bronchodilation.
Obstructive lung disease is the broader category that includes COPD and asthma, the conditions vilanterol is already used for. The mechanism is therefore the same as in its established uses, and the prediction is mechanistically coherent.
An important caveat is that the supporting evidence comes from fixed-dose combinations (fluticasone furoate/vilanterol, umeclidinium/vilanterol, and fluticasone furoate/umeclidinium/vilanterol), not from vilanterol alone. The contribution of vilanterol itself cannot be separated out from these studies.
Clinical Trial Evidence
The compiled data contain 28 trials for this indication. The table lists the 10 most relevant, prioritising completed, randomised, larger Phase 3 studies.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT03162055 | Phase 3 | Completed | 1119 | Glycopyrronium/formoterol vs umeclidinium/vilanterol over 24 weeks in moderate to very severe COPD |
| NCT01134042 | Phase 3 | Completed | 587 | Fluticasone furoate/vilanterol vs fluticasone furoate alone vs fluticasone propionate in persistent asthma over 24 weeks |
| NCT02094937 | Phase 3 | Completed | 430 | Step-down from fluticasone furoate/vilanterol 100/25 mcg to fluticasone furoate or fluticasone propionate in well-controlled Japanese asthma patients |
| NCT01686633 | Phase 3 | Completed | 1040 | Fluticasone furoate/vilanterol 200/25 and 100/25 mcg vs fluticasone furoate 100 mcg in moderate to severe persistent asthma |
| NCT02301975 | Phase 3 | Completed | 1526 | Once-daily fluticasone furoate/vilanterol vs twice-daily fluticasone propionate/salmeterol in asthma already controlled on ICS/LABA (non-inferiority) |
| NCT01706198 | Phase 3 | Completed | 4233 | 12-month open-label effectiveness study of fluticasone furoate/vilanterol vs usual maintenance therapy in asthma |
| NCT01342913 | Phase 3 | Completed | 528 | 24-hour lung function of fluticasone furoate/vilanterol vs salmeterol/fluticasone propionate in COPD |
| NCT01777334 | Phase 3 | Completed | 905 | Umeclidinium/vilanterol vs tiotropium over 24 weeks in COPD (trough FEV1) |
| NCT02487446 | Phase 3 | Completed | 357 | Indacaterol/glycopyrronium vs umeclidinium/vilanterol in moderate to severe COPD (FEV1 AUC0-24h) |
| NCT05062304 | N/A | Completed | 17281 | Registered as the IMPACT trial of single-inhaler triple vs dual therapy in COPD; the phase label should be verified |
Other trials in the compiled data include a withdrawn Phase 4 study (NCT04671355) and a withdrawn Phase 3 study (NCT01435902). Both enrolled no participants and provide no evidence.
Literature Evidence
The compiled data contain 20 publications. The table lists the 10 most relevant, prioritising RCTs, then meta-analyses and reviews.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 29668352 | 2018 | RCT | N Engl J Med | IMPACT: once-daily single-inhaler triple therapy vs dual therapy in COPD |
| 28375647 | 2017 | RCT | Am J Respir Crit Care Med | FULFIL: once-daily triple therapy vs ICS/LABA dual therapy in COPD |
| 32918892 | 2021 | RCT | Lancet Respir Med | CAPTAIN: fluticasone furoate/umeclidinium/vilanterol vs fluticasone furoate/vilanterol in inadequately controlled asthma (Phase 3A) |
| 32162970 | 2020 | RCT post hoc analysis | Am J Respir Crit Care Med | Reduced all-cause mortality with fluticasone furoate/umeclidinium/vilanterol in COPD, using updated vital status data from IMPACT |
| 35849317 | 2022 | Network meta-analysis | Adv Ther | Comparative efficacy of fluticasone furoate/umeclidinium/vilanterol vs other triple and dual therapies in COPD |
| 39797646 | 2024 | Cohort study | BMJ | Real-world comparison of two single-inhaler triple therapies in COPD |
| 39731707 | 2025 | Cohort study | Adv Ther | Real-world comparison of fluticasone furoate/umeclidinium/vilanterol and budesonide/glycopyrrolate/formoterol in US COPD patients |
| 40619503 | 2025 | Cohort study | Adv Ther | Comparison of the same two triple therapies in patients stepping up from dual therapy |
| 31389190 | 2019 | Systematic review | Clin Respir J | Fixed-dose umeclidinium/vilanterol in COPD |
| 28956463 | 2017 | Review | Expert Rev Respir Med | Role of once-daily fluticasone furoate/vilanterol in stable COPD |
New Zealand Market Information
All three licences are cancelled, so no currently valid authorisation was identified. The approved indication text is not available for any of them.
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 2494299 | Breo Ellipta | Powder for inhalation 100 mcg with vilanterol 25 mcg | Not available |
| 2494272 | Anoro Ellipta | Powder for inhalation 62.5 mcg with vilanterol 25 mcg | Not available |
| 2674904 | Trelegy Ellipta | Powder for inhalation, fluticasone furoate 100 mcg with umeclidinium 62.5 mcg and vilanterol 25 mcg | Not available |
Safety Considerations
- Drug Interactions: 388 interactions were identified in the interaction databases. Examples from the first 20 records reviewed:
- Moderate: antidiabetic agents (acarbose, albiglutide, alogliptin, canagliflozin, chlorpropamide, dapagliflozin, dulaglutide, empagliflozin), QT-prolonging drugs (cisapride, clarithromycin, dolasetron), and sympathomimetics (ephedrine, epinephrine, diethylpropion).
- Minor: corticosteroids (beclomethasone, betamethasone, budesonide, dexamethasone).
Package insert warnings and contraindications could not be retrieved. Please refer to the package insert for the full safety information.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Several completed Phase 3 RCTs and large pivotal trials support vilanterol-containing combinations in COPD and asthma, which gives an evidence level of L1. However, this is essentially an on-label use rather than true repurposing. The evidence is for fixed-dose combinations, not vilanterol alone, and all New Zealand licences are cancelled.
The other nine predicted indications (interstitial emphysema, compensatory emphysema, hyperlucent lung, tracheal stenosis, bronchial neoplasm, congenital lobar emphysema, respiratory malformation, tracheal calcification, laryngotracheitis) have little or no supporting evidence, with evidence levels of L4 to L5. They appear to be ontology-proximity artifacts and should be held.
To proceed, the following is needed:
- Package insert warnings and contraindications from Medsafe. The missing safety data is a blocking gap for safety screening.
- Mechanism-of-action data from DrugBank.
- Confirmation of the regulatory and market situation in New Zealand, since all three licences are cancelled and no approved indication text is available.
- Verification of the registry phase label for NCT05062304 (IMPACT).
- Evidence on the contribution of vilanterol alone, as the available trials test combinations.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.