This page shows what was measured, who it was measured in, and what that does not settle.
What Umeclidinium does in the body
A nerve running to the lungs keeps the muscle around each airway slightly tightened all the time.
Umeclidinium blocks the receptor that signal arrives at, and the muscle relaxes. It carries a permanent electrical charge, so it stays in the airway rather than spreading through the body, and it clears off the receptor slowly enough that one inhalation covers a day. It changes nothing about the destroyed lung tissue underneath, so it makes breathing easier without making the disease better.
Why people take it. A once-daily inhaler for long-term chronic obstructive pulmonary disease, blocking the nerve signal that tightens the airway
What happened in people
Trough FEV1 127 mL above placebo at 12 weeks and 0.072 to 0.167 L above placebo across arms at 24 weeks
✎ 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 recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.
Trough FEV1 +127 mL (62.5 micrograms) and +152 mL (125 micrograms) against placebo, both 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. 246 enrolled and 168 completed — 32% attrition over twelve weeks. The transitional dyspnoea index reached significance only at 125 micrograms, a dose never approved in the United States, and the published record carries a dosage-error correction.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Inhalation powder, 62.5 micrograms per blister, in the Ellipta dry-powder inhaler
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
All active arms 0.072 to 0.167 L above placebo (all p<0.001); umeclidinium-vilanterol above each monotherapy by 0.052 to 0.095 L (p<=0.004)
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. Every endpoint in this trial is a lung-function or symptom-scale measurement. Exacerbations were not a designed endpoint, and the trial ran 24 weeks — too short to count them reliably.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Inhalation powder, 62.5 micrograms per blister, in the Ellipta dry-powder inhaler
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Umeclidinium/vilanterol above umeclidinium by 66 mL (95% CI 43 to 89) and above salmeterol by 141 mL (95% CI 118 to 164), both p<0.001
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. Enrolment was restricted to patients at low exacerbation risk who were not taking inhaled corticosteroids, so the result does not transfer to the frequent-exacerbator population where most COPD prescribing decisions are made.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Inhalation powder, 62.5 micrograms per blister, in the Ellipta dry-powder inhaler
Interval reported. 95% CI 43 to 89) and above salmeterol by 141 mL (95% CI 118 to 164), both p<0
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 significantly more likely on triple therapy than on umeclidinium-vilanterol, hazard ratio 1.53 (95% CI 1.22 to 1.92, P<0.001). The umeclidinium-containing dual arm had the highest exacerbation rate of the three, and this is the trial the umeclidinium label cites for exacerbation efficacy.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Inhalation powder, 62.5 micrograms per blister, in the Ellipta dry-powder inhaler
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
RNAWiki holds 4 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
Umeclidinium
What a person takes: Inhalation powder, 62.5 micrograms per blister, in the Ellipta dry-powder inhaler.
The measurement behind this step
One inhalation once daily. Opening the cover indexes and pierces a foil blister; the dose is drawn in by the patient’s own inspiratory effort, with no propellant and no coordination step. This device is the only way umeclidinium has ever been administered in a trial, so its evidence and its hardware are the same object.
Getting in
One inhalation from a blister strip
Opening the cover pulls a foil blister into place and pierces it. The powder is drawn in by the breath — there is no propellant and nothing to press.
╌╌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
Umeclidinium bromide 62.5 micrograms micronised and blended with lactose monohydrate carrier in an Ellipta dry-powder inhaler. Every registration trial of this molecule used this device, so device performance and drug effect are not separable in the clinical record.
The molecule carries a fixed positive charge, so it does not readily cross membranes or reach the brain. What lands in the mouth and is swallowed contributes almost nothing.
╌╌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 quaternary azoniabicyclo[2.2.2]octane. The label describes the bronchodilation as predominantly a site-specific effect, which is the pharmacokinetic consequence of a permanently charged nitrogen.
It occupies the receptor with sub-nanomolar affinity
It sits in the place acetylcholine would land, on the muscle that wraps the airway, and it takes very little of the drug to do it.
──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
Ki values of 0.05 to 0.16 nM across cloned human M1 to M5, competitive antagonism with partial reversibility after washout. In CHO cells expressing human M3 the potency against acetylcholine-mediated calcium mobilisation was picomolar, and in human bronchial strips against carbachol it was similar.
It comes off the receptor on airway muscle about nine times more slowly than off the receptor found on the heart and on nerve endings. That gap is what a once-daily antimuscarinic is designed around.
──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
Reported dissociation half-lives of 82 minutes at M3 against 9 minutes at M2. Functional reversal in isolated human bronchus at 10 nM took about 381 minutes to reach 50% recovery, against 413 minutes for tiotropium measured alongside it — a like-for-like comparison that puts the two molecules in the same place.
Lung function measured a full day after the dose is still higher than it would have been — around a tenth of a litre more air in the first second of a forced breath out.
╌╌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
Trough FEV1 improvements against placebo of 127 mL at 12 weeks and 0.072 to 0.167 L across arms at 24 weeks, measured 23 to 24 hours after dosing. In guinea pigs 2.5 micrograms intratracheally gave 50% bronchoprotection for more than 24 hours.
No trial has given umeclidinium by itself and counted flare-ups, hospital admissions or deaths. Everything the label claims about flare-ups comes from a trial where it was one drug of three.
──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
The label sources its exacerbation evidence to IMPACT, a 10,355-patient trial of a three-component single inhaler. In IMPACT the umeclidinium-vilanterol arm had the highest exacerbation rate of the three at 1.21 per year, against 0.91 on triple therapy.
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 with chronic obstructive pulmonary disease as long-term maintenance treatment. It is not approved for asthma, and the label says so by omission rather than by warning: asthma appears nowhere in its indications.
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.
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness of INCRUSE ELLIPTA have not been established in pediatric patients.”
US prescribing information · dbb64747-1505-49d7-9a33-99dd402e96d3 · read 2026-08-30
On older people, the label states: “Clinical trials of INCRUSE ELLIPTA included 810 subjects aged 65 years and older, and, of those, 183 subjects were aged 75 years and older.”
US prescribing information · dbb64747-1505-49d7-9a33-99dd402e96d3 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary There are insufficient data on the use of umeclidinium in pregnant women to inform a drug‑associated risk.”
US prescribing information · dbb64747-1505-49d7-9a33-99dd402e96d3 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There is no information available on the presence of umeclidinium in human milk, the effects on the breastfed child, or the effects on milk production.”
US prescribing information · dbb64747-1505-49d7-9a33-99dd402e96d3 · read 2026-08-30
On people with reduced liver function, the label states: “Patients with moderate hepatic impairment (Child-Pugh score of 7-9) showed no relevant increases in C max or AUC, nor did protein binding differ between subjects with moderate hepatic impairment and their healthy controls.”
US prescribing information · dbb64747-1505-49d7-9a33-99dd402e96d3 · read 2026-08-30
On people with reduced kidney function, the label states: “Patients with severe renal impairment (CrCl <30 mL/min) showed no relevant increases in C max or AUC, nor did protein binding differ between subjects with severe renal impairment and their healthy controls.”
US prescribing information · dbb64747-1505-49d7-9a33-99dd402e96d3 · read 2026-08-30
Where the result stopped carrying
Nearly a third of the 12-week pivotal trial withdrew before completion
The 125-microgram dose that produced the larger dyspnoea and health-status effects was not approved in the United States
In IMPACT the umeclidinium-containing dual-bronchodilator arm had the highest exacerbation rate and the highest hospitalisation rate of the three regimens
No trial of this molecule has ever measured mortality, rate of FEV1 decline or cardiovascular outcomes over years
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, 62.5 micrograms per blister, in the Ellipta dry-powder inhaler
✎ 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. Opening the cover indexes and pierces a foil blister; the dose is drawn in by the patient’s own inspiratory effort, with no propellant and no coordination step. This device is the only way umeclidinium has ever been administered in a trial, so its evidence and its hardware 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
Not to be initiated in rapidly deteriorating or potentially life-threatening COPD and not for relief of acute symptoms — acute symptoms are to be treated with an inhaled short-acting beta-2 agonist. Paradoxical bronchospasm requires discontinuation. Worsening of narrow-angle glaucoma and worsening of urinary retention are both named in the label as reasons to contact a healthcare provider immediately, with caution advised in prostatic hyperplasia and bladder-neck obstruction. The most common adverse reactions at 2% or more and more common than placebo were nasopharyngitis, upper respiratory tract infection, cough and arthralgia.
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, 62.5 micrograms per blister, in the Ellipta dry-powder inhaler
✎ 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
Opening the cover indexes and pierces a foil blister; the dose is drawn in by the patient’s own inspiratory effort, with no propellant and no coordination step. This device is the only way umeclidinium has ever been administered in a trial, so its evidence and its hardware 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
2 published labels name it as an active ingredient. 2 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · dbb64747-1505-49d7-9a33-99dd402e96d3 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · dbb64747-1505-49d7-9a33-99dd402e96d3 · read 2026-08-29
Incruse Ellipta is oral at 3 DOSAGE FORMS AND STRENGTHS Inhalation powder: 62.5 mcg umeclidinium per actuation., recorded as fda label in effect 2023-12-13 in the United States.
US prescribing information · dbb64747-1505-49d7-9a33-99dd402e96d3 · 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 Umeclidinium 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 umeclidinium alone reduces COPD exacerbations — the label sources that claim to a trial of a three-drug inhaler
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 an 82-minute M3 off-rate makes it materially shorter-acting than tiotropium, when the one parallel functional experiment puts them within 10% of each other
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 a -7.9 to -10.87 unit health-status improvement in a 246-patient trial with 32% attrition is a settled result
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 its long-term cardiovascular and mortality safety is established, when it rests on the class rather than on any trial of this molecule
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 Umeclidinium 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.
Its own placebo-controlled trials measured lung function, and nothing else
In plain words
The two trials that support approval both asked the same question: how much more air can you blow out in one second, twenty-four hours after a dose? The answer was around 120 to 130 millilitres more than placebo. Neither trial counted flare-ups.
What was measured
Change from baseline in trough FEV1 at 12 and 24 weeks against placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
A 12-week randomised placebo-controlled trial enrolled 246 patients with moderate to very severe COPD; the primary endpoint was change from baseline in trough FEV1 on day 85. Umeclidinium 62.5 and 125 micrograms improved least-squares mean trough FEV1 by 127 and 152 mL against placebo (p<0.001), with 0-6-hour weighted mean improvements of 166 and 191 mL. In the 24-week trial (NCT01313650, 1,532 patients in the intent-to-treat population), all active arms improved trough FEV1 on day 169 by 0.072 to 0.167 L against placebo (all p<0.001), with the umeclidinium-vilanterol combination significantly greater than either monotherapy by 0.052 to 0.095 L (p<=0.004). Both trials used trough FEV1 as the primary endpoint. Neither was designed or powered to measure exacerbations.
Written into the record, not signed off as a reviewed claim
The label’s exacerbation claim is borrowed from a trial of a three-drug inhaler
In plain words
The prescribing information says outright where the evidence for preventing flare-ups comes from: a twelve-month trial of a combination containing umeclidinium plus two other drugs. Umeclidinium on its own has no exacerbation trial.
What was measured
That umeclidinium as a single agent reduces COPD exacerbations — a claim the label itself sources to a trial in which umeclidinium was never given alone
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Section 14 of the INCRUSE ELLIPTA prescribing information states: "Evidence of efficacy for INCRUSE ELLIPTA on COPD exacerbations was established by the efficacy of the umeclidinium component as part of a fixed-dose combination with an ICS/LABA, as assessed in a 12-month trial in 10,355 subjects." That trial is IMPACT, which compared fluticasone furoate plus umeclidinium plus vilanterol against fluticasone furoate-vilanterol and against umeclidinium-vilanterol. In IMPACT the umeclidinium-containing dual arm had the highest exacerbation rate of the three, 1.21 per year against 0.91 on triple therapy (rate ratio 0.75, 95% CI 0.70 to 0.81, P<0.001) and 1.07 on fluticasone furoate-vilanterol. Attributing the exacerbation benefit of a three-drug inhaler to one of its components is an inference from a factorial-looking design that was not factorial.
Written into the record, not signed off as a reviewed claim
A third of the 12-week trial did not finish it
In plain words
The trial that reported a striking quality-of-life improvement enrolled 246 people and 168 finished. Nearly a third left before the end, in a study lasting twelve weeks.
What was measured
Completion rate and St George’s Respiratory Questionnaire change at 12 weeks
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The 12-week placebo-controlled trial enrolled 246 patients and 168 completed, a completion rate of 68%. It reported St George’s Respiratory Questionnaire total score changes against placebo of -7.9 units for umeclidinium 62.5 micrograms and -10.87 units for 125 micrograms (both p<0.001), well beyond the conventional 4-unit threshold for clinical significance, and a transitional dyspnoea index focal score improvement that reached significance only at the higher 125-microgram dose. The published record carries a dosage-error correction notice. A health-status result of that size from a 246-patient study with 32% attrition is a weaker foundation than the effect size suggests, and the 125-microgram dose it partly rests on was never approved in the United States.
Written into the record, not signed off as a reviewed claim
IMPACT: adding a steroid beat the umeclidinium-vilanterol pair, and caused pneumonia
In plain words
In the largest trial umeclidinium has appeared in, the two-bronchodilator combination containing it had the most flare-ups of the three arms. Adding an inhaled steroid cut flare-ups by a quarter and raised the risk of pneumonia by half.
What was measured
Annual rate of moderate or severe COPD exacerbations across three single-inhaler regimens
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
IMPACT randomised 10,355 patients with COPD to 52 weeks of once-daily fluticasone furoate 100 micrograms plus umeclidinium 62.5 micrograms plus vilanterol 25 micrograms, or fluticasone furoate-vilanterol, or umeclidinium-vilanterol, each in a single Ellipta inhaler. Moderate or severe exacerbations were 0.91 per year on triple therapy against 1.07 on fluticasone furoate-vilanterol (rate ratio 0.85, 95% CI 0.80 to 0.90, P<0.001) and 1.21 on umeclidinium-vilanterol (rate ratio 0.75, 95% CI 0.70 to 0.81, P<0.001). Severe exacerbations leading to hospitalisation were 0.13 against 0.19 on umeclidinium-vilanterol (rate ratio 0.66, 95% CI 0.56 to 0.78, P<0.001). Pneumonia was more common in the glucocorticoid-containing arms, with clinician-diagnosed pneumonia significantly more likely on triple therapy than on umeclidinium-vilanterol, hazard ratio 1.53 (95% CI 1.22 to 1.92, P<0.001).
Written into the record, not signed off as a reviewed claim
EMAX: adding a beta-agonist bought 66 mL over umeclidinium alone
In plain words
A 24-week trial in nearly 2,700 people compared umeclidinium with vilanterol, umeclidinium alone, and salmeterol alone. The pair beat umeclidinium alone by 66 millilitres of lung function and salmeterol alone by 141.
What was measured
Trough FEV1 at week 24, dual bronchodilator against each monotherapy
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
EMAX was a 24-week double-blind, double-dummy, parallel-group trial in patients at low exacerbation risk not receiving inhaled corticosteroids, randomised to umeclidinium/vilanterol 62.5/25 micrograms once daily, umeclidinium 62.5 micrograms once daily or salmeterol 50 micrograms twice daily. Change from baseline in trough FEV1 at week 24 was 66 mL greater with the combination than with umeclidinium (95% CI 43 to 89) and 141 mL greater than with salmeterol (95% CI 118 to 164), both p<0.001. Transition Dyspnoea Index at week 24 favoured the combination over umeclidinium by 0.37 units (95% CI 0.06 to 0.68, p=0.018) and over salmeterol by 0.45 (0.15 to 0.76, p=0.004). The risk of a first clinically important deterioration fell by 16 to 25% against umeclidinium and 26 to 41% against salmeterol depending on the definition used.
Written into the record, not signed off as a reviewed claim
The receptor off-rate is quoted in minutes here and in hours for tiotropium
In plain words
Umeclidinium is described as leaving its target receptor with a half-life of eighty-two minutes. Tiotropium is described as thirty-five hours. Both drugs are taken once a day. The two figures came from different laboratories using different methods and do not mean what putting them side by side suggests.
What was measured
That umeclidinium leaves the M3 receptor twenty-five times faster than tiotropium — a comparison between numbers produced by different assays in different laboratories, which the one parallel functional experiment contradicts
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Umeclidinium binds cloned human M1 to M5 receptors with Ki values of 0.05 to 0.16 nM, and dissociation half-lives of labelled compound were reported as 82 minutes at M3 and 9 minutes at M2. Tiotropium’s corresponding published figures are 34.7 hours at M3 and 3.6 hours at M2, measured two decades earlier in a different laboratory with a different tracer. The only like-for-like comparison in the umeclidinium paper is functional and run in parallel: in isolated human bronchial strips at 10 nM, time to 50% restoration of contraction was about 381 minutes for umeclidinium and 413 minutes for tiotropium. That comparison shows the two behaving almost identically, and it is the one that supports once-daily dosing for both.
Written into the record, not signed off as a reviewed claim
There is no long-term outcome trial of this molecule
In plain words
Tiotropium has a four-year trial in 5,993 people and a safety trial in 17,135. Umeclidinium has neither. Its longest dedicated study is a twelve-month safety trial, and its largest appearance is inside a three-drug inhaler.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The prescribing information describes the efficacy basis as three dose-ranging trials in 624 subjects, two placebo-controlled confirmatory trials in 1,738 subjects at 12 and 24 weeks, a 12-month long-term safety trial, and four 12-week trials of umeclidinium added to an inhaled corticosteroid plus long-acting beta-agonist in 1,637 subjects. Nothing in that programme measures mortality, rate of lung function decline or cardiovascular outcomes over years. The class-level cardiovascular question raised for inhaled antimuscarinics in 2008 was answered for tiotropium by UPLIFT and TIOSPIR; for umeclidinium it rests on the class rather than on the molecule.
Source
INCRUSE ELLIPTA United States prescribing information, Clinical Studies 14 and Adverse Reactions 6.1
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
How many documents were read
2 documents were read for this substance.
RNAWiki source record
2 of them state the same halfLife, and they agree.
RNAWiki source record
2 of them state the same proteinBinding, and they agree.
RNAWiki source record
2 of them state the same volumeOfDistribution, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
7AN603V4JV
RxNorm concept
1539251
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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 quaternary antimuscarinic with sub-nanomolar affinity at all five muscarinic receptors and slow functional reversal at M3, which raised trough lung function by 115 to 127 mL against placebo in its own 12- and 24-week trials; its label’s exacerbation claim comes not from those trials but from IMPACT, where umeclidinium was one of three drugs in a single inhaler given to 10,355 people.
Recorded evidence blocks (10)
Q1
On the Umeclidinium label: indicated for what?
"Umeclidinium ELLIPTA is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Umeclidinium ELLIPTA is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).": indications and usage on Umeclidinium's label. DailyMed label · 763388a5-cc89-4c25-8562-521df679b7e8 · 2025-11-06
Q2
37 registered trials of Umeclidinium — at which phases?
"FDA advised that study is no longer required"; 4 of 37 registered studies
Show the evidence
Trial
NCT01653483
withdrawn; "FDA advised that study is no longer required"
NCT02731846
withdrawn; "It has been determined on June 10th that the 205165 study will not progress. This decision has been made prior to study start, no patients were screened."
NCT03662711
terminated; "Contract terminated between AIFA and the Sponsor (University of Ferrara)"
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
Q4
Human studies of Umeclidinium used GSK573719 250 μg — over how long?
Human studies of Umeclidinium used "GSK573719 250 μg". ClinicalTrials.gov · 2026-09-01
20 recorded entries; human; also "GSK573719 500 μg", "GSK573719 1000 μg", "GSK573719 125mcg"
Show the evidence
human
NCT01013974
GSK573719 250 μg
NCT01013974
GSK573719 500 μg
NCT01013974
GSK573719 1000 μg
NCT01030965
GSK573719 125mcg
NCT01030965
GSK573719 250mcg
NCT01030965
GSK573719 500mcg
14 more recorded rows
humanNCT01313637
GSK573719/GW642444 125/25mcg
humanNCT01521377
GSK573719/Vilanterol 125/25mcg
humanNCT01521377
GSK573719/Vilanterol 500/100mcg
humanNCT01521390
GSK573719 62.5 mcg (one strip)
humanNCT01521390
GSK573719 62.5 mcg(two strips)
humanNCT01521390
GSK573719 125 mcg (one strip)
humanNCT01521390
GSK573719 125 mcg(two strips)
humanNCT01716520
Umeclidinium/Vilanterol 62.5/25 mcg
humanNCT01716520
Umeclidinium 62.5 mcg
humanNCT01772134
Umeclidinium bromide 62.5mcg
humanNCT01772134
Umeclidinium bromide 125mcg
humanNCT02731846
Fluticasone furoate 100 mcg + Umeclidinium 62.5 mcg+Vilanterol 25 mcg
11 hours; Excretion : The effective half-life after once-daily orally inhaled dosing is 11 hours.
metabolismpharmacokinetics
Elimination Metabolism : In vitro data showed that umeclidinium is primarily metabolized by the enzyme cytochrome P450 2D6 (CYP2D6) and is a substrate for the P-glycoprotein (P-gp) transporter.
recorded 2025-11-06 · last checked 2026-09-04
Q6
Which 7 trials of Umeclidinium posted no result?
Posted no result
7 of 7 completed trials
Registrations
NCT00475436, NCT00976144, NCT01013974, NCT01128634, NCT01110018 and NCT01521390, and 1 more
Completion dates
oldest 2007-09-18; newest 2012-06-05
Show the evidence
Trial
NCT00475436
2007-09-18
NCT00976144
2009-09-22
NCT01013974
2009-12-18
NCT01128634
2010-04-26
NCT01110018
2010-06-09
NCT01521390
2011-12-16
1 further recorded trialNCT01521377
2012-06-05
Q7
At the median, Umeclidinium's trials enrolled 163 people — anything larger?
Median enrolment
163
Largest enrolment
11316
Registered trials counted
37
Q8
What do 295 spontaneous reports say about Umeclidinium — 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.
Umeclidinium appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 295 reaction mentions were counted: dyspnoea 59; asthma 52; cough 41; wheezing 28. FAERS via Open Targets · CHEMBL1187833 · 2026-06-24
Show the evidence
dyspnoea
59
asthma
52
cough
41
wheezing
28
urinary retention
25
therapeutic product effect incomplete
21
4 more recorded rows
chronic obstructive pulmonary disease
20
blood count abnormal
19
obstructive airways disorder
17
sputum discoloured
13
recorded 2026-06-24 · last checked 2026-09-04
Q9
Which 10 reactions does Umeclidinium's label not list?
Elimination Metabolism : In vitro data showed that umeclidinium is primarily metabolized by the enzyme cytochrome P450 2D6 (CYP2D6) and is a substrate for the P-glycoprotein (P-gp) transporter.
pharmacokinetics
Impact of Intrinsic and Extrinsic Factors on the Systemic Exposure of Umeclidinium Drug Interaction Studies Umeclidinium and P-glycoprotein Transporter: Umeclidinium is a substrate of P-gp.
pharmacokinetics
The effect of the moderate P-gp transporter inhibitor verapamil (240 mg once daily) on the steady-state pharmacokinetics of umeclidinium was assessed in healthy subjects.
pharmacokinetics
Umeclidinium and Cytochrome P450 2D6: In vitro metabolism of umeclidinium is mediated primarily by CYP2D6.
pharmacokinetics
However, no clinically meaningful difference in systemic exposure to umeclidinium (500 mcg) (8 times the approved dose) was observed following repeat daily inhaled dosing to normal (ultrarapid, extensive, and intermediate metabolizers) and CYP2D6 poor metabolizer subjects ( Figure 1 ).
clinical_pharmacology
Elimination Metabolism : In vitro data showed that umeclidinium is primarily metabolized by the enzyme cytochrome P450 2D6 (CYP2D6) and is a substrate for the P-glycoprotein (P-gp) transporter.
2 more recorded rows
Interaction statementclinical_pharmacology
Impact of Intrinsic and Extrinsic Factors on the Systemic Exposure of Umeclidinium Drug Interaction Studies Umeclidinium and P-glycoprotein Transporter: Umeclidinium is a substrate of P-gp.
Interaction statementclinical_pharmacology
The effect of the moderate P-gp transporter inhibitor verapamil (240 mg once daily) on the steady-state pharmacokinetics of umeclidinium was assessed in healthy subjects.
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 · openFDA / DailyMed — US Government work
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
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