This page shows what was measured, who it was measured in, and what that does not settle.
What Vilanterol does in the body
The airway-relaxing part of once-daily combination inhalers. It is not prescribed alone.
Vilanterol switches on the same receptor on airway muscle that adrenaline uses, raising a chemical messenger inside the cell that makes the muscle relax. It is built to stay in place for a full day rather than half of one, so the inhaler is used once every twenty-four hours. It does nothing to the inflammation or the tissue damage underneath — which is why it is never sold on its own, and why the products containing it always pair it with a steroid, an antimuscarinic, or both.
What happened in people
Used alone, it did not reduce deaths or slow the loss of lung function.
✓ Reviewed first-read answer
Where this came from
A person wrote this and a reviewer approved it against this exact record. It carries no effect size.
A reviewer approved this against this record. The reviewed-claim record carrying the exact population and effect size does not exist yet.
No source is stored against this line.
The limit that matters most
The combination did not clearly improve survival, so its other reported findings need caution.
Where it acts
Beta-2 adrenoceptors on bronchial smooth muscle, reached by dry powder deposited in the conducting airways
Kind of result
What a body can do day to day
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · 40AHO2C6DG · read 2026-08-29
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
The limit a reviewer approved as the one that matters most here.
The four opening statements run to 114 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
All-cause mortality in moderate COPD with heightened cardiovascular risk
Combination hazard ratio 0.88 (95% CI 0.74 to 1.04), p=0.137; vilanterol alone 0.96 (0.81 to 1.14), p=0.655; fluticasone furoate alone 0.91 (0.77 to 1.08), p=0.284
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. The published findings state that because the primary outcome was not met, secondary outcomes should be interpreted with caution. The 8 mL per year reduction in FEV1 decline widely quoted from this trial is one of those secondary outcomes, and vilanterol alone did not produce it (-2 mL per year, 95% CI -8 to 5).
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Inhalation powder, 25 micrograms per blister, in the Ellipta dry-powder inhaler, always co-formulated
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Yearly rate of moderate and severe COPD exacerbations, fluticasone furoate/vilanterol against vilanterol alone
✗ The study did not show it
Who was studied
Dransfield replicate trials (NCT01009463 and NCT01017952)
How many people
3255
Study design
Phase 3, two replicate double-blind, parallel-group, randomised trials, one year
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Study 1: 200/25 against vilanterol alone 0.90 against 1.05 events per year, ratio 0.9 (95% CI 0.7 to 1.0) — not significant, and the statistical hierarchy blocked inference for the lower doses. Study 2: all three doses significant (p=0.0398, 0.0244, 0.0004). Pooled: all three significant.
Repeated elsewhere
Partially Replicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. Pneumonia and fractures were more frequent with fluticasone furoate and vilanterol than with vilanterol alone, and there were eight deaths from pneumonia in the combination groups against none in the vilanterol-only group.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Inhalation powder, 25 micrograms per blister, in the Ellipta dry-powder inhaler, always co-formulated
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Decramer replicate trials (NCT01316900 and NCT01316913)
How many people
2332
Study design
Phase 3, two multicentre, blinded, double-dummy, active-controlled trials, 24 weeks
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Umeclidinium plus vilanterol above vilanterol alone by 0.088 L (95% CI 0.036 to 0.140, p=0.0010) and 0.090 L (0.039 to 0.142, p=0.0006); above tiotropium by 0.060 to 0.090 L; not above umeclidinium 125 micrograms alone (0.037 L, -0.012 to 0.087, p=0.14 and 0.022 L, -0.027 to 0.072, p=0.38)
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. No significant differences in symptoms, health status or exacerbation risk between the combination and tiotropium monotherapy. The lung-function advantage did not translate into a difference on any of those endpoints over 24 weeks.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Inhalation powder, 25 micrograms per blister, in the Ellipta dry-powder inhaler, always co-formulated
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Rate of moderate or severe exacerbations among patients with an exacerbation in the year before the trial
✓ The study showed what it set out to show
Who was studied
Salford Lung Study COPD (NCT01551758)
How many people
2799
Study design
Phase 3, randomised, open-label, usual-care-controlled effectiveness trial, one year
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
8.4% lower with fluticasone furoate-vilanterol (95% CI 1.1 to 15.2), P=0.02
Repeated elsewhere
Unreplicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. No significant difference in COPD-related primary or secondary care contacts, and no significant difference in time to first moderate or severe exacerbation or first severe exacerbation. The single positive result is the annualised rate.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Inhalation powder, 25 micrograms per blister, in the Ellipta dry-powder inhaler, always co-formulated
Interval reported. 95% CI 1
Written into the record, not signed off as a reviewed claim.
Triple 0.91/year against fluticasone furoate-vilanterol 1.07 (rate ratio 0.85, 95% CI 0.80 to 0.90, P<0.001) and against umeclidinium-vilanterol 1.21 (rate ratio 0.75, 95% CI 0.70 to 0.81, P<0.001)
Repeated elsewhere
Partially Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Clinician-diagnosed pneumonia was more likely on triple therapy than on umeclidinium-vilanterol, hazard ratio 1.53 (95% CI 1.22 to 1.92, P<0.001). Vilanterol is present in all three arms, so this trial says nothing about the vilanterol component.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Inhalation powder, 25 micrograms per blister, in the Ellipta dry-powder inhaler, always co-formulated
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 5 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What it changes in the body◇Read from sources, not yet reviewed
The path through the body
From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.
Start
Vilanterol
What a person takes: Inhalation powder, 25 micrograms per blister, in the Ellipta dry-powder inhaler, always co-formulated.
The measurement behind this step
One inhalation once daily. The Ellipta device holds one or two blister strips inhaled together, which is how a three-drug regimen fits into one actuation. Vilanterol has never been supplied in any other device or as a single-ingredient product, so its device and its evidence are the same object.
Getting in
One inhalation from a foil blister
Opening the inhaler cover indexes a blister and pierces it. The powder is drawn in by the breath. Every product containing vilanterol works this way and no other.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Vilanterol trifenatate 25 micrograms of the base, micronised with lactose carrier, in an Ellipta dry-powder inhaler alongside fluticasone furoate, umeclidinium, or both in separate blister strips inhaled together.
The dichlorobenzyl tail anchors it near the receptor
Like the older long-acting beta-agonists, half the molecule is a long chain that does not act on the receptor at all. It lodges in the fatty membrane so the working end stays within reach for a full day.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
A saligenin ethanolamine head connected through a hexyl-ethoxy linker to a 2,6-dichlorobenzyl ether. The lipophilic halogenated tail is the structural difference from salmeterol’s phenylbutoxy chain and is the accepted basis for the extension from about twelve hours to twenty-four.
The active end fits into the same receptor adrenaline uses and switches it on. The label says its selectivity in the test tube looks like salmeterol’s, and that nobody knows what that means in a patient.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
Agonism at ADRB2. The label states only that in vitro functional selectivity was similar to that of salmeterol, with clinical relevance unknown, and notes that beta-2 receptors comprise 10% to 50% of total beta-adrenoceptors in the human heart.
The switched-on receptor makes the cell produce a signalling chemical, and the more of it there is the more the muscle relaxes.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
The receptor couples to Gs, activating adenylyl cyclase and converting ATP to cyclic AMP. The label attributes the pharmacologic effect at least in part to that step, together with inhibition of mediator release from mast cells.
One dose covers a full day, which is the entire design goal. In practice that means one inhaler, once, in the morning — and one fewer dose to forget.
╌╌Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.
The measurement behind this step
Twenty-four-hour bronchodilation supports once-daily dosing across all three combination products. In head-to-head 24-week trials, adding umeclidinium to vilanterol raised trough FEV1 by about 90 mL over vilanterol alone.
In the one large trial where thousands of people took vilanterol by itself for about two years, deaths, heart events and the rate of lung-function loss were all the same as on placebo.
──Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.
The measurement behind this step
In SUMMIT, vilanterol monotherapy in 4,118 patients gave a mortality hazard ratio of 0.96 (95% CI 0.81 to 1.14, p=0.655), a cardiovascular composite hazard ratio of 0.99 (0.80 to 1.22) and a change in the rate of FEV1 decline of -2 mL per year (95% CI -8 to 5). Exacerbation rates fell with all active treatments including vilanterol.
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 6 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
People prescribed Breo, Anoro or Trelegy. Nobody takes vilanterol alone, because no such product exists in any market.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
Where the result stopped carrying
SUMMIT missed its primary mortality endpoint at p=0.137 in 16,590 patients
Vilanterol monotherapy changed neither mortality, nor cardiovascular events, nor the rate of FEV1 decline in that trial
One of the two replicate exacerbation trials failed to show a difference against vilanterol alone even at the highest steroid dose
Adding vilanterol to umeclidinium 125 micrograms gave no significant lung-function gain in the head-to-head trial designed to test it
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Inhalation powder, 25 micrograms per blister, in the Ellipta dry-powder inhaler, always co-formulated
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
One inhalation once daily. The Ellipta device holds one or two blister strips inhaled together, which is how a three-drug regimen fits into one actuation. Vilanterol has never been supplied in any other device or as a single-ingredient product, so its device and its evidence are the same object.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take◇Read from sources, not yet reviewed
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
·Worth asking a clinician aboutWritten into the record from the studies named on this page
Long-acting beta-agonist monotherapy increases the risk of serious asthma-related events, which is why no single-ingredient vilanterol product exists. Not to be initiated in acutely deteriorating COPD or asthma and not for acute symptoms. Not to be combined with any other long-acting beta-agonist because of overdose risk. Paradoxical bronchospasm requires discontinuation, and caution applies in cardiovascular disorders because of beta-adrenergic stimulation. The corticosteroid-containing products add oropharyngeal candidiasis, increased pneumonia risk in COPD, worsening of existing infections, adrenal suppression on transfer from systemic steroids, and reduced bone mineral density.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Inhalation powder, 25 micrograms per blister, in the Ellipta dry-powder inhaler, always co-formulated
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
The Ellipta device holds one or two blister strips inhaled together, which is how a three-drug regimen fits into one actuation. Vilanterol has never been supplied in any other device or as a single-ingredient product, so its device and its evidence are the same object.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
18 products list this as an active ingredient in the United States drug directory. 9 of them contain it and nothing else.
FDA National Drug Code directory · 47848-054 · read 2026-08-29
They are sold as powder, taken respiratory (inhalation).
FDA National Drug Code directory · 47848-054 · read 2026-08-29
5 published labels name it as an active ingredient. None of them describes this substance alone, so no label text on this page can be attributed to it rather than to a combination.
US prescribing information · 2dbd0671-c565-40c5-bf0f-e324db26799c · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 2dbd0671-c565-40c5-bf0f-e324db26799c · read 2026-08-29
Anoro Ellipta is respiratory (inhalation) at 3 DOSAGE FORMS AND STRENGTHS Inhalation powder: 62.5 mcg umeclidinium and 25 mcg vilanterol (62.5/25 mcg) per actuation., recorded as fda label in effect 2023-06-02 in the United States.
US prescribing information · 2dbd0671-c565-40c5-bf0f-e324db26799c · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Vilanterol studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
Claims that go past the evidence
Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.
✗Goes past the evidence
That the benefits of Breo, Anoro and Trelegy can be apportioned to the vilanterol component, which only SUMMIT tested directly
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That fluticasone furoate with vilanterol slows lung-function decline — a secondary outcome the trial’s own authors flagged after the primary endpoint failed
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That vilanterol is more beta-2 selective than older agents, a claim the label declines to quantify and calls of unknown clinical relevance
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the pneumonia and fracture excess in the combination trials belongs to vilanterol, when it tracks the inhaled corticosteroid arm
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Vilanterol are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
What happened in people◇Read from sources, not yet reviewed
Check any of this yourself
Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.
Every line above can be traced to the study named beside it. Follow the link and read it.
SUMMIT: 4,118 people took vilanterol alone, and it changed nothing measurable
In plain words
The largest trial ever to give vilanterol by itself put more than four thousand people on it until the trial had counted enough deaths to stop. Deaths were unchanged. The rate at which lung function fell was unchanged. The steroid arm of the same trial did slow that decline; the vilanterol arm did not.
What was measured
All-cause mortality, rate of FEV1 decline and composite cardiovascular events, vilanterol monotherapy against placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
SUMMIT randomised 16,590 patients aged 40 to 80 with post-bronchodilator FEV1 of 50% to 70% predicted and a history of or increased risk of cardiovascular disease, one-to-one-to-one-to-one, to placebo, fluticasone furoate 100 micrograms, vilanterol 25 micrograms, or the combination, once daily. Compared with placebo, all-cause mortality was unaffected by vilanterol alone (hazard ratio 0.96, 95% CI 0.81 to 1.14, p=0.655), by fluticasone furoate alone (0.91, 0.77 to 1.08, p=0.284) or by the combination (0.88, 0.74 to 1.04, p=0.137). The rate of FEV1 decline was reduced by the combination (38 mL per year against 46 for placebo, difference 8 mL per year, 95% CI 1 to 15) and by fluticasone furoate (difference 8 mL per year, 95% CI 1 to 14), but not by vilanterol (difference -2 mL per year, 95% CI -8 to 5). Composite cardiovascular events were unaffected by all three (vilanterol hazard ratio 0.99, 95% CI 0.80 to 1.22).
Written into the record, not signed off as a reviewed claim
SUMMIT missed its primary endpoint, and its authors said to read the rest carefully
In plain words
The trial was built to show that the combination improved survival. It did not, at p=0.137. The paper then says in its own findings that because the primary outcome was not met, the secondary outcomes should be interpreted with caution — including the finding about slowing lung-function decline that is most often quoted from it.
What was measured
That fluticasone furoate with vilanterol slows lung-function decline in moderate COPD — a secondary outcome in a trial that missed its primary endpoint, which the authors flagged as requiring caution
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The primary outcome of SUMMIT was all-cause mortality; the secondary outcomes were on-treatment rate of FEV1 decline and a composite of cardiovascular events. The combination gave a hazard ratio of 0.88 (95% CI 0.74 to 1.04, a 12% relative reduction, p=0.137). The published findings state directly that because of this, secondary outcomes should be interpreted with caution. The 8 mL per year reduction in FEV1 decline attributed to fluticasone furoate is one of those secondary outcomes, and it is a difference of 8 mL against a placebo decline of 46 mL per year — around one sixth of the slope, in a trial whose statistical gatekeeper did not open.
Written into the record, not signed off as a reviewed claim
One of the two replicate exacerbation trials did not reach significance
In plain words
Two identical year-long trials asked whether adding a steroid to vilanterol prevents more flare-ups than vilanterol alone. The second one said yes at every dose. The first one did not reach significance even at the highest dose, and the way the statistics were ordered meant the lower doses in that trial could not be tested at all.
What was measured
Yearly rate of moderate and severe COPD exacerbations, fluticasone furoate/vilanterol against vilanterol alone
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Two replicate double-blind parallel-group one-year trials randomised 1,622 and 1,633 patients to vilanterol 25 micrograms alone or with fluticasone furoate 50, 100 or 200 micrograms once daily, with yearly rate of moderate and severe exacerbations as the primary endpoint. In study 1 there was no significant difference between fluticasone furoate/vilanterol 200/25 and vilanterol alone (0.90 against 1.05 events per year; ratio 0.9, 95% CI 0.7 to 1.0), and because of the statistical hierarchy used, significance could not be inferred for the 50 and 100 microgram groups. In study 2 all three combination groups beat vilanterol alone (p=0.0398, 0.0244 and 0.0004). The pooled analysis was significant for all three doses. Pneumonia and fractures were reported more frequently with fluticasone furoate and vilanterol than with vilanterol alone.
Written into the record, not signed off as a reviewed claim
Eight deaths from pneumonia in the steroid arms, none in the vilanterol-only arm
In plain words
In the same pair of trials, eight people died of pneumonia among those taking the steroid with vilanterol. Nobody taking vilanterol alone did.
What was measured
Deaths from pneumonia and pneumonia incidence, inhaled corticosteroid arms against non-steroid arms
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Across the two replicate one-year trials, pneumonia and fractures were reported more frequently in the fluticasone furoate/vilanterol groups than in the vilanterol-only group, and eight deaths from pneumonia were recorded in the fluticasone furoate/vilanterol groups against none in the vilanterol-only group. In IMPACT, the 10,355-patient triple-therapy trial, clinician-diagnosed pneumonia was significantly more likely on the fluticasone furoate-containing triple regimen than on umeclidinium-vilanterol, hazard ratio 1.53 (95% CI 1.22 to 1.92, P<0.001). SUMMIT, in a milder population, reported no excess pneumonia — 6% on combination against 5% on placebo. The signal is real, it belongs to the inhaled corticosteroid rather than to vilanterol, and its size depends on how severe the population is.
Written into the record, not signed off as a reviewed claim
Adding vilanterol to umeclidinium 125 micrograms produced no significant gain
In plain words
Two replicate trials tested the combination against each of its parts. Against tiotropium and against vilanterol alone the pair won. Against the higher dose of umeclidinium alone it did not — the confidence interval crossed zero twice.
What was measured
Trough FEV1 on day 169, umeclidinium plus vilanterol against each monotherapy and against tiotropium
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Two 24-week randomised, blinded, double-dummy trials recruited 1,141 and 1,191 participants to umeclidinium 125 plus vilanterol 25, umeclidinium 62.5 plus vilanterol 25, tiotropium 18, and either vilanterol 25 (study 1) or umeclidinium 125 (study 2), with trough FEV1 on day 169 as the primary endpoint. Both combination doses beat tiotropium (0.088 and 0.090 L in study 1, 0.074 and 0.060 L in study 2) and both beat vilanterol monotherapy (0.088 L, 95% CI 0.036 to 0.140, p=0.0010; 0.090 L, 0.039 to 0.142, p=0.0006). Neither beat umeclidinium 125 micrograms monotherapy: 0.037 L (95% CI -0.012 to 0.087, p=0.14) and 0.022 L (-0.027 to 0.072, p=0.38). There were no significant differences in symptoms, health status or exacerbation risk between the combination and tiotropium.
Written into the record, not signed off as a reviewed claim
Salford: an 8.4% exacerbation reduction in ordinary general practice, and nothing else
In plain words
A trial run inside real general practices, with almost no exclusion criteria, put 2,799 people on the combination or on whatever they would have had anyway. Flare-ups fell by 8.4%. Nothing else the trial measured moved.
What was measured
Rate of moderate or severe COPD exacerbations under everyday general-practice conditions
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Salford Lung Study randomised 2,799 patients with COPD across 75 general practices to once-daily fluticasone furoate 100 micrograms plus vilanterol 25 micrograms or to usual care, with the rate of moderate or severe exacerbations among those with an exacerbation in the previous year as the primary outcome. That rate was 8.4% lower with the combination (95% CI 1.1 to 15.2, P=0.02). There was no significant difference in the annual rate of COPD-related contacts with primary or secondary care, and no significant between-group difference in time to first moderate or severe exacerbation or time to first severe exacerbation. There were no excess serious adverse events of pneumonia.
Written into the record, not signed off as a reviewed claim
Everything claimed for this molecule is claimed for a product containing it
In plain words
Vilanterol has never been marketed on its own, in any country. The two-drug and three-drug inhalers it lives in carry all the evidence, and separating out what the beta-agonist contributes is an inference rather than a measurement — except in SUMMIT, where it was given alone and produced nothing.
What was measured
That vilanterol’s contribution to the products containing it can be read from trials of those products — a component attribution that only SUMMIT tested directly, and that SUMMIT did not support
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Vilanterol trifenatate exists commercially only in Breo Ellipta (with fluticasone furoate), Anoro Ellipta (with umeclidinium) and Trelegy Ellipta (with both). The label’s pharmacology section says only that in vitro functional selectivity was similar to salmeterol’s and that the clinical relevance is unknown; no numeric selectivity ratio, receptor affinity or dissociation half-life appears in it. The monotherapy evidence that does exist comes from control arms: 4,118 patients in the vilanterol arm of SUMMIT, where mortality, cardiovascular events and FEV1 decline were all unchanged, and roughly 209 patients over 24 weeks in one of the Decramer trials, where the pair beat it by about 90 mL. On this page the combination results are labelled as combination results throughout.
Source
BREO ELLIPTA United States prescribing information, Clinical Pharmacology 12.1; Vestbo J et al., Lancet 2016;387:1817-1826; Decramer M et al., Lancet Respir Med 2014;2:472-486
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim
Where else this substance is registered
FDA substance identifier (UNII)
40AHO2C6DG
CAS registry number
503070-58-4
PubChem compound
44482554
ChEMBL
CHEMBL1198857
ChEBI
75040
RxNorm concept
1424883
EMA substance identifier
100000128871
DrugBank
DBSALT001121
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
no quarantine open
✓ Passed
Every public sentence names a source
The opening statement carries the origin: Reviewed first-read answer.
✗ Not passed
Trial roles classified for highlighted evidence
No registered study is classified as testing this substance.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✗ Not passed
Safety mode resolved
No register row and no identity class settled the question.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
3 approved applications cover products containing this substance. The earliest was NDA204275, approved 20130510 to GLAXO GRP LTD.
This order is fixed in code and does not count clicks or time on the page.
What is not here
7 questions this page could not answer
These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.
What was measured, goal by goal — found nothing in the sources checked.
How close this is to real life — found nothing in the sources checked.
Felt, measured, or meaningful — found nothing in the sources checked.
How long anything takes — found nothing in the sources checked.
What it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
A once-daily beta-2 agonist whose functional selectivity the label describes as similar to salmeterol’s, sold only inside combination inhalers; in SUMMIT, where 4,118 people took it alone until the trial’s target number of deaths had accrued, all-cause mortality was unchanged (hazard ratio 0.96, 95% CI 0.81 to 1.14, p=0.655) and the rate of FEV1 decline was unchanged (-2 mL per year, 95% CI -8 to 5), while the steroid it is usually paired with did move that second number.
Recorded evidence blocks (6)
Q1
47 registered trials of Vilanterol — at which phases?
"Contract terminated between AIFA and the Sponsor (University of Ferrara)"; 3 of 47 registered studies
Show the evidence
Trial
NCT03662711
terminated; "Contract terminated between AIFA and the Sponsor (University of Ferrara)"
NCT07223294
withdrawn; "In response to evolving regulations, product specific guidance by Health Authorities globally, Sandoz plans to streamline its clinical development programs and has therefore strategically decided to discontinue the SAN 1138 clinical study."
NCT07541378
suspended; "Recruitment was temporarily suspended pending additional funding and activation of additional study centers. The pilot phase has been completed and is currently being evaluated. The suspension was not related to safety concerns."
recorded 2026-09-01 · last checked 2026-09-04
Q3
Human studies of Vilanterol used GW642444 (25, 100 & 400 mcg/day) — over how long?
Human studies of Vilanterol used "GW642444 (25, 100 & 400 mcg/day)". ClinicalTrials.gov · 2026-09-01
15 recorded entries; human; also "GW642444H (100mcg)", "GW642444M (25, 100 & 400 mcg)", "GW642444 3mcg"
TRELEGY ELLIPTA 100Mcg-62.5Mcg-25Mcg/Actuation Powder for Inhalation
humanNCT07133880
umeclidinium 62.5 µg and vilanterol 25 µg
recorded 2026-09-01 · last checked 2026-09-04
Q4
Which 14 trials of Vilanterol posted no result?
Posted no result
14 of 14 completed trials
Registrations
NCT00354874, NCT00381667, NCT00347139, NCT00463697, NCT00625196 and NCT00671216, and 8 more
Completion dates
oldest 2005-06; newest 2019-11-26
Show the evidence
Trial
NCT00354874
2005-06
NCT00381667
2007-01
NCT00347139
2007-01-10
NCT00463697
2007-08-04
NCT00625196
2008-05-06
NCT00671216
2008-07-07
8 further recorded trials
NCT00702910
2008-10-04
NCT00964249
2008-12-01
NCT00711126
2008-12-17
NCT00783003
2009-02-06
NCT00976144
2009-09-22
NCT01299558
2010-07-15
NCT01213849
2010-11-25
NCT03152149
2019-11-26
Q5
At the median, Vilanterol's trials enrolled 73 people — anything larger?
Median enrolment
73
Largest enrolment
16568
Registered trials counted
47
Q6
What do 2976 spontaneous reports say about Vilanterol — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Vilanterol appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2976 reaction mentions were counted: asthma 592; dyspnoea 479; wheezing 363; cough 291. FAERS via Open Targets · CHEMBL1084172 · 2026-06-24
Show the evidence
asthma
592
dyspnoea
479
wheezing
363
cough
291
therapeutic product effect incomplete
289
obstructive airways disorder
245
4 more recorded rows
pneumonia
204
blood count abnormal
195
chest discomfort
165
loss of personal independence in daily activities
153
recorded 2026-06-24 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL 37 — CC BY-SA 3.0 Unported · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 5 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.