Summary
Vilanterol Trifenatate 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 6 registered trials linking Vilanterol Trifenatate to Asthma: 1 is active or not yet recruiting; 5 have completed. The most advanced is Phase 4 (NCT06372496). It plans or enrolled 1366 participants. Registration activity spans 2012 to 2024. The literature layer holds 4 publications for this pair: 4 clinical trial publications. Publication years run from 2012 to 2022. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
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 | 51.5 (trials 23.5, literature 8.0, tier 15, approved bonus 5.0) |
| Registered trials | 6 total: 0 recruiting, 1 active / not yet recruiting, 5 completed, 0 other |
| Linked publications | 4 (4 clinical trial publications) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT06372496 | Pragmatic Open - Label Randomized Clinical Trial of FF/UMEC/VI vs Non-ellipta Usual Care ICS-LABA for Adult Participants With Uncontrolled Asthma 2024 | active, not recruiting | Phase 4 | 1,366 |
| NCT01498653 | Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry 2012 | completed | Phase 3 | 313 |
| NCT03184987 | A Long-term Safety Study of Fixed Dose Combination Therapy Fluticasone Furoate/Umeclidinium Bromide/Vilanterol Trifenatate in Japanese Subjects With Asthma 2017 | completed | Phase 3 | 111 |
| NCT01498679 | Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry. 2012 | completed | Phase 3 | 311 |
| NCT04265105 | Fluticasone-Vilanterol Once Daily Dose for the Treatment of Mild Asthma in Adults 2021 | completed | PHASE2, PHASE3 | 18 |
| NCT03378648 | A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose in Healthy Volunteers, Repeat Doses in Asthmatic Patients and of Single Dose in COPD Patients of CHF6366 2017 | completed | PHASE1, PHASE2 | 118 |
Published literature
- Clinical trial publication Metabolomic changes related to airway inflammation, asthma pathogenesis and systemic activity following inhaled fluticasone furoate/vilanterol: a randomized controlled trialDaley-Yates P, Keppler B, Baines A et al. · Respiratory research · 2022 · PMID 36127726
- Clinical trial publication Anti-inflammatory duration of action of fluticasone furoate/vilanterol trifenatate in asthma: a cross-over randomised controlled trialBardsley G, Daley-Yates P, Baines A et al. · Respiratory research · 2018 · PMID 30001712
- Clinical trial publication 24-h duration of the novel LABA vilanterol trifenatate in asthma patients treated with inhaled corticosteroidsLötvall J, Bateman ED, Bleecker ER et al. · The European respiratory journal · 2012 · PMID 22362859
- Clinical trial publication Fluticasone furoate demonstrates efficacy in patients with asthma symptomatic on medium doses of inhaled corticosteroid therapy: an 8-week, randomised, placebo-controlled trialBusse WW, Bleecker ER, Bateman ED et al. · Thorax · 2012 · PMID 21828231
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 Vilanterol Trifenatate approved for Asthma?
Vilanterol Trifenatate 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 Vilanterol Trifenatate in clinical trials for Asthma?
ClinicalTrials.gov lists 6 registered trials linking Vilanterol Trifenatate to Asthma: 1 is active or not yet recruiting; 5 have completed. The most advanced is Phase 4 (NCT06372496). It plans or enrolled 1366 participants. Registration activity spans 2012 to 2024.
What does the evidence show for Vilanterol Trifenatate in Asthma?
Vilanterol Trifenatate has 5 completed trials and 4 linked publications for Asthma. Completed trials may or may not have posted results; follow the NCT links to check. 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.