This page shows what was measured, who it was measured in, and what that does not settle.
What Budesonide does in the body
Preventing asthma, or treating inflammatory bowel disease and hay fever in other forms.
Asthma is inflammation in the lining of the airway, and budesonide switches that inflammation off at its source. Breathed in, it crosses into the cells lining the airway and binds a receptor that carries it into the nucleus, where it silences the genes that make inflammatory signals and switches on the ones that dampen them. Most of the dose that lands in the mouth and is swallowed is destroyed by the liver before it reaches the bloodstream, which is what keeps the effect largely in the lung. It does nothing to open an airway that is closing right now — budesonide will not rescue an attack, and using it as though it would is dangerous.
What happened in people
Daily low-dose treatment cut severe asthma attacks by 44% over three years.
✓ 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
A home COVID-19 study shortened recovery but did not clearly reduce hospital admissions.
Where it acts
Airway epithelium and submucosal inflammatory cells (inhaled); ileal and ascending-colonic mucosa (oral delayed-release)
Kind of result
The kind of result is not recorded
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
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 141 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.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
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.
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.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Endurance
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
…Waiting for a reviewer1 registered performance measure of this kind.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Endurance
endurance time
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
… Waiting for a reviewer
1 registered performance measure of this kind.
— Not recorded
Harms were not a registered measure for this goal.
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.
Time to first severe asthma-related event
✓ The study showed what it set out to show
Who was studied
START — inhaled Steroid Treatment As Regular Therapy
How many people
7241
Study design
Randomised double-blind placebo-controlled trial, 3 years, 32 countries
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Hazard ratio 0.56 (95% CI 0.45 to 0.71), P < 0.0001
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. Three-year growth in children under 11 was 1.34 cm lower on budesonide, most of it lost in the first year. It is in the published abstract and is rarely quoted alongside the exacerbation result.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Dry-powder inhaler, nebuliser suspension, nasal spray, and oral delayed-release capsules and extended-release tablets
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Childhood Asthma Management Program (CAMP) — the randomised trial the adult-height analysis follows (NCT00000575) · a recorded source, not a stored snapshot
Randomised controlled trial, 4 to 6 years of treatment, height measured at mean age 24.9
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Budesonide 1.2 cm lower than placebo (95% CI -1.9 to -0.5), P = 0.001; nedocromil 0.2 cm lower, P = 0.61
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. This is the adverse finding. 943 of the 1,041 randomised children (90.6%) were traced and measured, which is an unusually complete follow-up and makes the result hard to dismiss as attrition.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Dry-powder inhaler, nebuliser suspension, nasal spray, and oral delayed-release capsules and extended-release tablets
Interval reported. 95% CI -1
Written into the record, not signed off as a reviewed claim.
Childhood Asthma Management Program (CAMP) — the randomised trial the adult-height analysis follows (NCT00000575) · a recorded source, not a stored snapshot
Childhood Asthma Management Program (CAMP) — the randomised trial the adult-height analysis follows (NCT00000575) · a recorded source, not a stored snapshot
Hazard ratio 1.07 (95% CI 0.70 to 1.65), non-inferiority margin 2.0 met; exacerbation hazard ratio 0.84 (0.74 to 0.94), P = 0.002
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. Both asthma-related deaths in the trial were in the combination arm. With 83 events in total the trial cannot resolve a difference that small, and says so.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Dry-powder inhaler, nebuliser suspension, nasal spray, and oral delayed-release capsules and extended-release tablets
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Childhood Asthma Management Program (CAMP) — the randomised trial the adult-height analysis follows (NCT00000575) · a recorded source, not a stored snapshot
Coprimary: time to first self-reported recovery, and COVID-related hospital admission or death within 28 days
✗ The study did not show it
Who was studied
PRINCIPLE budesonide arm (ISRCTN86534580)
How many people
2530
Study design
Open-label adaptive platform trial in UK primary care
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Recovery met superiority (2.94 days faster, probability > 0.999 against threshold 0.99); hospitalisation or death odds ratio 0.75 (95% BCI 0.55 to 1.03), probability 0.963 against threshold 0.975 — not met
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. Open-label design with a self-reported primary endpoint. `endpoint met: false` records that one of the two coprimary endpoints failed, not that both did.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Dry-powder inhaler, nebuliser suspension, nasal spray, and oral delayed-release capsules and extended-release tablets
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Childhood Asthma Management Program (CAMP) — the randomised trial the adult-height analysis follows (NCT00000575) · a recorded source, not a stored snapshot
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 happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.8 registered measures of this kind. 1 written-up study measured this and did not show a benefit.
■What a body can do day to dayEvidence recorded. Walking, dressing, breathing, recovering.1 registered measure of this kind.
■Measured performanceEvidence recorded. How much was lifted, how far was run, how fast.1 registered measure of this kind.
■Symptoms and quality of lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.2 registered measures of this kind.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.1 registered measure of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
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
Budesonide
What a person takes: Dry-powder inhaler, nebuliser suspension, nasal spray, and oral delayed-release capsules and extended-release tablets.
The measurement behind this step
The route is the drug. Inhaled budesonide reaches the airway lining and is then largely destroyed by the liver if swallowed; the delayed-release oral capsule is coated to release in the ileum and ascending colon and relies on the same first-pass metabolism to keep systemic exposure low. The nebuliser suspension exists because a young child cannot coordinate an inhaler, not because it is more effective.
Getting in
Breathed in, and mostly swallowed
Only a fraction of a puff reaches the small airways. The rest lands in the mouth and throat and is swallowed, which is where the mouth infections and the hoarse voice come from.
╌╌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
Lung deposition from the dry-powder inhaler is on the order of 15 to 30% of the metered dose and is inspiratory-flow dependent; the remainder is oropharyngeal. The swallowed fraction has an oral systemic availability of approximately 6 to 13% because of extensive CYP3A4 first-pass metabolism.
Childhood Asthma Management Program (CAMP) — the randomised trial the adult-height analysis follows (NCT00000575) · a recorded source, not a stored snapshot
Reaching the cell
It crosses into the cells lining the airway
Budesonide is fat-soluble enough to pass straight through the membrane of the cells lining the airway, without needing a transporter to carry 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
Passive diffusion across the epithelial plasma membrane driven by lipophilicity (logP approximately 3.2). Inside airway cells a fraction is reversibly esterified to budesonide-21-oleate, an inactive depot that hydrolyses back to free drug — the proposed explanation for airway retention beyond the roughly 2 to 3 hour plasma half-life.
Childhood Asthma Management Program (CAMP) — the randomised trial the adult-height analysis follows (NCT00000575) · a recorded source, not a stored snapshot
What it acts on
It grabs the glucocorticoid receptor and rides it into the nucleus
A receptor sits waiting in the cell body. Budesonide binds it, the pair travel into the nucleus, and the receptor becomes able to reach the DNA.
╌╌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
Binding to the cytosolic glucocorticoid receptor (NR3C1) displaces the HSP90 chaperone complex, exposing nuclear localisation signals. The label puts budesonide affinity at roughly 200-fold that of cortisol in standard models. The receptor dimerises and translocates through the nuclear pore.
Childhood Asthma Management Program (CAMP) — the randomised trial the adult-height analysis follows (NCT00000575) · a recorded source, not a stored snapshot
The change it makes
It silences the genes that make inflammation
In the nucleus the receptor switches off the genes that produce inflammatory signals, and switches on a few that dampen them. The effect is on what the cell manufactures, which is why it takes days to weeks rather than minutes.
╌╌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
Transrepression of NF-kappa-B and AP-1 driven genes — GM-CSF, IL-4, IL-5, IL-8, eotaxin — largely through recruitment of histone deacetylase 2 to the activated transcriptional complex, alongside transactivation of anti-inflammatory genes including annexin A1 and MKP-1. Nothing here acts on airway smooth muscle tone.
Childhood Asthma Management Program (CAMP) — the randomised trial the adult-height analysis follows (NCT00000575) · a recorded source, not a stored snapshot
What that does for a person
The airway lining calms down, and severe attacks become rarer
Over weeks the lining becomes less swollen and less twitchy. The measurable payoff is fewer severe attacks and fewer courses of steroid tablets, not a dramatic change in how much air you can blow 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
Reduced eosinophil and mast cell infiltration of the bronchial mucosa and reduced airway hyperresponsiveness. In START this produced a hazard ratio of 0.56 for first severe asthma-related event over three years, against a post-bronchodilator FEV1 gain of only 0.88% of predicted at three years.
Childhood Asthma Management Program (CAMP) — the randomised trial the adult-height analysis follows (NCT00000575) · a recorded source, not a stored snapshot
What that does for a person
The fraction that escapes the liver acts everywhere else
Whatever is absorbed through the lung goes straight into the bloodstream and bypasses the liver entirely. That is the part that suppresses growth in children and bruises skin in adults.
──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
Pulmonary absorption is not subject to first-pass metabolism, so lung-deposited drug contributes directly to systemic exposure. Measured consequences: 1.2 cm lower adult height after 4 to 6 childhood years in CAMP, and skin bruising in 10% versus 4% over three years in EUROSCOP.
Childhood Asthma Management Program (CAMP) — the randomised trial the adult-height analysis follows (NCT00000575) · a recorded source, not a stored snapshot
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 it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
short inflammatory bowel disease questionnaire
total nasal symptom
Measured
Things only a test, a scale or a device shows.
serum alkaline phosphatase
endurance time
Meaningful
Things that change how a life goes, not only a number.
rate of remission
rate of clinical remission after 8 weeks
clinical and endoscopic remission
rate of clinical remission at week 8
who achieved remission
achieving clinical remission
rate of clinical remission
hospitalization rate
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (28)
clinical symptoms
symptoms stool frequency and consistency
dyspnea
time to first severe asthma exacerbation
morning peak expiratory flow
forced expiratory volume in one second
inhaled corticosteroid prescriptions refilled
height
asthma 2 hours after intervention
asthma at 2 hours
forced expiratory volume in 1 second pre dose
adverse events
fev1 predicted
forced expiratory volume in 1 second
treatment emergent adverse events related to study drug
asthma exacerbation
histological response to treatment
symptomatic response to treatment
albumin
lung function
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to take◇Read from sources, not yet reviewed
How long anything takes
Nine different lengths of time that get confused with each other. None of them is worked out from another.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
How long people were followed.Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.
How fast the body clears it. 2.3 hours hours
Read from the label, which states: “In asthmatic children 4 to 6 years of age, the terminal half-life of budesonide after nebulization is 2.3 hours, and the systemic clearance is 0.5 L/min, which is approximately 50% greater than in healthy adults after adjustment for differences in weight.”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
Beyond the studies. Nothing is recorded about the long term.
The longest finished study sets the edge of what anyone measured.
A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.
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.
Anyone with asthma beyond the mildest intermittent form, in every major guideline worldwide. Budesonide is on the WHO Model List of Essential Medicines, and the nebuliser suspension is the standard inhaled steroid for young children.
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: “Safety and effectiveness in children six months to 12 months of age has been evaluated but not established.”
US prescribing information · 87048fa9-3391-4f30-801d-b96ca0132f56 · read 2026-08-30
On older people, the label states: “Of the 215 patients in 3 clinical trials of budesonide inhalation suspension in adult patients, 65 (30%) were 65 years of age or older, while 22 (10%) were 75 years of age or older.”
US prescribing information · 87048fa9-3391-4f30-801d-b96ca0132f56 · read 2026-08-30
On people who are pregnant, the label states: “Congenital malformations were studied in 2014 infants born to mothers reporting the use of inhaled budesonide for asthma in early pregnancy (usually 10 to 12 weeks after the last menstrual period), the period when most major organ malformations occur.”
US prescribing information · 87048fa9-3391-4f30-801d-b96ca0132f56 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no available data on the effects of budesonide inhalation suspension on the breastfed child or on milk production.”
US prescribing information · 87048fa9-3391-4f30-801d-b96ca0132f56 · read 2026-08-30
On people with reduced liver function, the label states: “Formal pharmacokinetic studies using budesonide inhalation suspension have not been conducted in patients with hepatic impairment.”
US prescribing information · 87048fa9-3391-4f30-801d-b96ca0132f56 · read 2026-08-30
Where the result stopped carrying
EUROSCOP: three years of budesonide did not change the rate of FEV1 decline in mild COPD, beyond a one-time improvement in the first six months
The same trial found skin bruising in 10% on budesonide against 4% on placebo
START recorded 1.34 cm of lost three-year growth in children under 11, prospectively, in the trial that established the benefit
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 for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
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 (10)
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
Dry-powder inhaler, nebuliser suspension, nasal spray, and oral delayed-release capsules and extended-release tablets
✎ 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
The route is the drug.
✎ 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. The rest of the recorded wording: Inhaled budesonide reaches the airway lining and is then largely destroyed by the liver if swallowed; the delayed-release oral capsule is coated to release in the ileum and ascending colon and relies on the same first-pass metabolism to keep systemic exposure low. The nebuliser suspension exists because a young child cannot coordinate an inhaler, not because it is more effective.
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
Local effects are oral candidiasis, dysphonia and cough. Systemic effects come from the fraction absorbed through the lung, which bypasses the liver: reduced growth velocity in children with a measured 1.2 cm loss in attained adult height, skin bruising, and at higher exposures adrenal suppression, cataract, glaucoma and reduced bone mineral density. Strong CYP3A4 inhibitors including ketoconazole and ritonavir raise plasma budesonide several-fold and have produced Cushing syndrome and adrenal suppression. Budesonide is not a rescue medicine and does not treat an acute attack.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
Childhood Asthma Management Program (CAMP) — the randomised trial the adult-height analysis follows (NCT00000575) · a recorded source, not a stored snapshot
Reports sent to a regulator
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.
Budesonide appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 11346 reaction mentions were counted. One report can name several reactions.
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
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
Dry-powder inhaler, nebuliser suspension, nasal spray, and oral delayed-release capsules and extended-release tablets
✎ 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
A recorded note compares this form with the others that are sold. It is kept below, word for word.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
The recorded note, unchanged: Inhaled budesonide reaches the airway lining and is then largely destroyed by the liver if swallowed; the delayed-release oral capsule is coated to release in the ileum and ascending colon and relies on the same first-pass metabolism to keep systemic exposure low. The nebuliser suspension exists because a young child cannot coordinate an inhaler, not because it is more effective.
No source is stored against this line.
What is recorded as being sold
135 products list this as an active ingredient in the United States drug directory. 114 of them contain it and nothing else.
FDA National Drug Code directory · 76282-642 · read 2026-08-29
They are sold as aerosol, aerosol, foam, aerosol, metered, aerosol, powder, capsule and capsule, coated pellets, taken nasal, oral, rectal and respiratory (inhalation).
FDA National Drug Code directory · 76282-642 · read 2026-08-29
The regulator's established pharmacologic class for it is corticosteroid hormone receptor agonists [moa] and corticosteroid [epc].
FDA National Drug Code directory · 76282-642 · read 2026-08-29
70 published labels name it as an active ingredient. 56 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · dc529fc4-bddb-4673-8202-dc401f86166f · read 2026-08-29
Those labels are classed as human otc drug and human prescription drug.
US prescribing information · dc529fc4-bddb-4673-8202-dc401f86166f · read 2026-08-29
Recorded price in US: 0.70346–3.65304 USD per one millilitre, across 34 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Recorded price in US: 9.54869 USD per one gram, for the one priced product, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
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 Budesonide 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 inhaled budesonide reduces COVID-19 hospitalisation or death — that coprimary endpoint in PRINCIPLE reached a probability of 0.963 against its own prespecified threshold of 0.975
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 childhood growth suppression on inhaled corticosteroids is recovered — held for two decades, and contradicted by the same cohort measured in adulthood
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 FEV1 improvement is what the drug does for people; the measured lung-function gain in START was under 1% of predicted at three years while exacerbations nearly halved
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 inhaled and oral budesonide can be reasoned about interchangeably because they are the same molecule; first-pass metabolism makes their systemic exposure profiles different objects
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 Budesonide 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.
START: 44% fewer severe asthma events over three years in 7,241 patients
In plain words
People whose asthma had started within the previous two years were given either low-dose budesonide once a day or a placebo for three years. Severe attacks fell by nearly half.
What was measured
Time to first severe asthma-related event over three years, and change in FEV1 as percent predicted
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The inhaled Steroid Treatment As Regular Therapy (START) trial randomised 7,241 patients aged 5 to 66 in 32 countries with mild persistent asthma of less than two years duration and no previous regular corticosteroid, to budesonide 400 micrograms daily (200 micrograms under age 11) or placebo added to usual therapy, for three years. The primary outcome was time to first severe asthma-related event. It occurred in 198 of 3,568 on placebo and 117 of 3,597 on budesonide, hazard ratio 0.56 (95% CI 0.45 to 0.71, p<0.0001). Post-bronchodilator FEV1 rose 1.48% of predicted at one year and 0.88% at three years against placebo; the pre-bronchodilator gain was 2.24% and 1.71%. The lung-function effect is real and small; the exacerbation effect is the reason the drug is prescribed.
Written into the record, not signed off as a reviewed claim
The growth effect was called temporary for twenty years, then the cohort grew up
In plain words
Inhaled steroids were known to slow growth for a year or two, and the field held that children caught up and reached a normal adult height. When the trial children were measured at an average age of 25, the lost centimetre was still missing.
What was measured
That the growth suppression seen in the first years of inhaled corticosteroid treatment is recovered and does not affect attained adult height — an inference from short-term catch-up data that the same cohort disproved when it reached adulthood
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Childhood Asthma Management Program randomised 1,041 children aged 5 to 13 to budesonide 400 micrograms daily, nedocromil 16 mg daily or placebo for 4 to 6 years. Adult height was later measured in 943 of them (90.6%) at a mean age of 24.9 years. Mean adult height was 1.2 cm lower in the budesonide group than placebo (95% CI -1.9 to -0.5, p=0.001) and 0.2 cm lower with nedocromil (95% CI -0.9 to 0.5, p=0.61). A larger daily dose in the first two years predicted lower adult height, at -0.1 cm per microgram per kilogram of body weight (p=0.007). The deficit was the same size as the one measured after two years (-1.3 cm), so it was not progressive or cumulative — it was permanent. The START trial had recorded the same thing prospectively: 1.34 cm of three-year growth lost in children under 11, most of it in the first year.
Written into the record, not signed off as a reviewed claim
EUROSCOP: three years of budesonide did not slow lung-function decline in COPD
In plain words
More than a thousand smokers with early COPD took budesonide or placebo for three years. Their lung function got slightly better in the first six months and then declined at exactly the same rate as everyone else.
What was measured
Rate of post-bronchodilator FEV1 decline over three years, and incidence of skin bruising
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The European Respiratory Society Study on Chronic Obstructive Pulmonary Disease randomised 1,277 subjects with mild COPD who continued smoking (mean age 52, mean FEV1 77% of predicted) to inhaled budesonide 400 micrograms twice daily or placebo for three years after a six-month run-in; 912 completed. Median three-year post-bronchodilator FEV1 decline was 140 mL on budesonide against 180 mL on placebo (p=0.05). In the first six months FEV1 improved at 17 mL per year on budesonide against a decline of 81 mL per year on placebo (p<0.001); from nine months to the end of treatment the two arms declined at the same rate (p=0.39). Skin bruising occurred in 10% on budesonide against 4% on placebo (p<0.001). The authors concluded there was a small one-time improvement and no effect on the long-term progressive decline.
Written into the record, not signed off as a reviewed claim
The FDA-mandated safety trial: no excess of serious asthma events, in 11,693 people
In plain words
A trial ordered by the regulator asked whether adding formoterol to budesonide made asthma more dangerous. It did not, and the combination produced 16.5% fewer attacks.
What was measured
First adjudicated serious asthma-related event and first asthma exacerbation over 26 weeks
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
A 26-week double-blind trial randomised 11,693 patients aged 12 and over with persistent asthma and one to four exacerbations in the previous year to budesonide-formoterol (n=5,846) or budesonide alone (n=5,847); those with a history of life-threatening asthma were excluded. The primary safety endpoint, first adjudicated serious asthma-related event (death, intubation or hospitalisation), occurred in 43 on the combination and 40 on budesonide alone, hazard ratio 1.07 (95% CI 0.70 to 1.65), meeting the prespecified non-inferiority margin of 2.0. There were two asthma-related deaths, both in the combination group, one of whom had also been intubated. First asthma exacerbation was 16.5% less likely on the combination, hazard ratio 0.84 (95% CI 0.74 to 0.94, p=0.002). Registered enrolment was 12,460; 11,693 were randomised.
Written into the record, not signed off as a reviewed claim
The COVID hospitalisation claim did not meet its own superiority threshold
In plain words
Inhaled budesonide shortened recovery from COVID-19 by about three days in older people at home. It was widely reported as also cutting hospital admissions. The trial itself said that part did not reach the bar it had set in advance.
What was measured
That inhaled budesonide reduces COVID-19 hospitalisation and death — a coprimary endpoint that fell short of its own prespecified superiority threshold and is routinely quoted as though it had been met
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
PRINCIPLE, an open-label adaptive platform trial in UK primary care, analysed 2,530 SARS-CoV-2-positive participants aged 65 and over, or 50 and over with comorbidities: 787 assigned budesonide 800 micrograms twice daily for 14 days, 1,069 usual care, 974 other interventions. Time to first self-reported recovery improved by an estimated 2.94 days (95% BCI 1.19 to 5.12; 11.8 days versus 14.7 days; hazard ratio 1.21, 95% BCI 1.08 to 1.36), with probability of superiority greater than 0.999 against a threshold of 0.99 — that coprimary endpoint was met. The other coprimary, COVID-related hospital admission or death, was 6.8% (95% BCI 4.1 to 10.2) against 8.8% (5.5 to 12.7), odds ratio 0.75 (95% BCI 0.55 to 1.03), probability of superiority 0.963 against a prespecified threshold of 0.975. It did not clear it. The trial was open-label and the recovery endpoint was self-reported, which is the weaker of the two designs for the endpoint that succeeded.
Written into the record, not signed off as a reviewed claim
First-pass metabolism is the whole safety argument, and it is a measured number
In plain words
Most of an inhaled dose is swallowed rather than inhaled. Budesonide is designed so that the swallowed part is destroyed by the liver before it can act anywhere else in the body.
What was measured
Oral systemic bioavailability of approximately 6 to 13%, and glucocorticoid activity of the principal metabolites of under 1% of parent
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The FDA label reports that budesonide undergoes extensive first-pass hepatic metabolism, with systemic availability of the orally administered drug of approximately 6 to 13% in adults, mediated principally by CYP3A4 to 6-beta-hydroxybudesonide and 16-alpha-hydroxyprednisolone, both with less than 1% of the glucocorticoid activity of the parent. This is why oral and inhaled budesonide are different drugs in practice despite being the same molecule, and it is also why the label carries an interaction warning for strong CYP3A4 inhibitors such as ketoconazole and ritonavir, which raise plasma budesonide several-fold and can produce systemic corticosteroid effects including Cushing syndrome and adrenal suppression.
Source
FDA prescribing information for budesonide (Pulmicort Flexhaler, Pulmicort Respules and Uceris), clinical pharmacology and drug interactions sections
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
How many documents were read
51 documents were read for this substance.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
Q3OKS62Q6X
CAS registry number
51333-22-3
PubChem compound
5281004
RxNorm concept
19831
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
38 approved applications cover products containing this substance. The earliest was NDA020233, approved 19940214 to ASTRAZENECA.
This order is fixed in code and does not count clicks or time on the page.
What is not here
3 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 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 corticosteroid that enters airway cells, carries the glucocorticoid receptor into the nucleus and shuts down the transcription of inflammatory genes; over three years in 7,241 people with recent-onset mild asthma it cut severe asthma events by 44%, and in the children of a parallel programme it cost 1.2 cm of final adult height — a trade the field spent two decades describing as temporary before the cohort grew up and it was not.
Recorded evidence blocks (15)
Q1
What did Budesonide's largest trial (66581 people) and its longest (20 years) measure?
66581 people in Budesonide's largest registered study, 20 years in its longest registered window, measuring Area under the curve (AUC) of the plasma concentrations of the steroid components 0 - 10 hours after study drug inhalation in patients with COPD and healthy volunteers. ClinicalTrials.gov · 2026-09-01
116 phase3, 70 phase2, 70 phase4, 36 na, 33 phase1, 13 na or unstated, 5 early phase1; NCT00000575; 2012-03; no ageing endpoint recorded. Last human test completed 2026, NCT07777796.
Interpretation These counts include studies where Budesonide was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase3
116
phase2
70
phase4
70
na
36
phase1
33
na or unstated
13
2 more recorded rows
early phase1
5
Last recorded human testNCT07777796
2026-07-30
recorded 2026-09-01 · last checked 2026-09-04
Q2
From mouse to human: where has Budesonide shown biomarker?
Area under the curve (AUC) of the plasma concentrations of the steroid components 0 - 10 hours after study drug inhalation in patients with COPD and healthy… — the recorded outcome words.
Show the evidence
mouse
mechanism-only
humanNCT00379028
biomarker; Area under the curve (AUC) of the plasma concentrations of the steroid components 0 - 10 hours after study drug inhalation in patients with COPD and healthy volunteers; 327
budesonide 80 or 160ug/formoterol 4.5ug, 2 inhalations bid
humanNCT00679380
Budesonide MMX® 6 mg
humanNCT00679380
Budesonide MMX® 9 mg
humanNCT00679380
Entocort EC® 3 mg
humanNCT00716963
budesonide 400 mcg
humanNCT00716963
Pulmicort Turbuhaler 200 mcg
humanNCT00747110
Budenofalk 3mg capsules
humanNCT01219738
Budesonide 360ug
humanNCT01219738
Budesonide 720ug
humanNCT01219738
Budesonide 1440ug
humanNCT01865500
Budesonide 4 mg
humanNCT01865500
Budesonide 8 mg
humanNCT02409563
nasal; Budesonide nasal spray (100 mcg bid)
humanNCT02409563
nasal; Budesonide nasal spray (50 mcg bid
recorded 2026-09-01 · last checked 2026-09-04
Q5
Budesonide's half-life is 2.3 hours — which schedules were studied?
2.3 hours, the half-life Budesonide's label states. openfda-label · 3235e2a4-8e12-2d58-e063-6294a90a4936 · 2026-08-30
Show the evidence
half life
2.3 hours hours; In asthmatic children 4 to 6 years of age, the terminal half-life of budesonide after nebulization is 2.3 hours, and the systemic clearance is 0.5 L/min, which is approximately 50% greater than in healthy adults after adjustment for differences in weight.
bioavailability
12.3 Pharmacokinetics Absorption: In asthmatic children 4 to 6 years of age, the total absolute bioavailability (i.e., lung + oral) following administration of budesonide inhalation suspension via jet nebulizer was approximately 6% of the labeled dose.
metabolism
Metabolism: In vitro studies with human liver homogenates have shown that budesonide is rapidly and extensively metabolized.
recorded 2026-08-30 · last checked 2026-09-04
Q6
Could one person measure Budesonide's effect on serum alkaline phosphatase?
Serum alkaline phosphatase: measured in Budesonide's trials.
Interpretation serum alkaline phosphatase is the recorded endpoint.
Show the evidence
biomarkers
serum alkaline phosphatase; 2026-09-01
clinical symptoms; 2026-09-01
symptoms stool frequency and consistency; 2026-09-01
endurance time; 2026-09-01
dyspnea; 2026-09-01
time to first severe asthma exacerbation; 2026-09-01
14 more recorded rows
biomarkers
morning peak expiratory flow; 2026-09-01
biomarkers
forced expiratory volume in one second; 2026-09-01
0; NCT00388739; NA; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN
Q7
Which of achieving clinical remission, adverse event and adverse events did Budesonide's trials measure?
achieving clinical remission, adverse event and adverse events lead 40 outcome terms across Budesonide's trials. ClinicalTrials.gov · 2026-09-01
Interpretation endurance time, dyspnea, time to first severe asthma exacerbation, morning peak expiratory flow, forced expiratory volume in one second and inhaled corticosteroid prescriptions refilled follow.
Show the evidence
serum alkaline phosphatase
1
clinical symptoms
1
symptoms stool frequency and consistency
1
endurance time
1
dyspnea
1
time to first severe asthma exacerbation
1
14 more recorded rows
morning peak expiratory flow
1
forced expiratory volume in one second
1
inhaled corticosteroid prescriptions refilled
1
rate of remission
1
height
1
asthma 2 hours after intervention
1
asthma at 2 hours
1
rate of clinical remission after 8 weeks
1
forced expiratory volume in 1 second pre dose
1
adverse events
1
fev1 predicted
1
forced expiratory volume in 1 second
1
clinical and endoscopic remission
1
treatment emergent adverse events related to study drug
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Budesonide's 28 ongoing trials reports first?
use exhaled nitric oxide as a surrogate marker of large airway vs small airway/lung inflammation following various doses of inhaled corticosteroids; Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling; latest 2029-03
Show the evidence
Trial
NCT00576069
"Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma"; n 60; "use exhaled nitric oxide as a surrogate marker of large airway vs small airway/lung inflammation following various doses of inhaled corticosteroids"; 2027-06
NCT04278404
"Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)"; n 5000; "Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling"; 2026-12
NCT04342039
"Epigenetic Health Benefits of Budesonide"; n 20; "Budesonide affect on allergic rhinitis plus allergen (48 hrs)"; 2027-12-31
NCT04545866
"The Budesonide in Babies (BiB) Trial"; n 642; "Physiologic BPD or Death by 36 Weeks PMA"; 2026-12-17
NCT05405387
"Impact of Budesonide on Incidence of ≥ Gr2 Diarrhea in Multiple Myeloma (MM) Patients Undergoing Autologous Stem Cell Transplant"; n 120; "Proportion of patients with delayed engraftment (engraftment after day 18) and severe infection related complications (≥ Grade 4 NCI CTCAE v5)."; 2028-03
NCT05509933
"Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation"; n 110; "non-infectious fever"; 2027-12-30
14 further recorded trials
NCT05562466
"A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma"; n 200; "Change from baseline in trough FEV1"; 2028-05-30
NCT05791487
"Combination of Diet and Oral Budesonide for Ulcerative Colitis"; n 90; "Steroid free remission"; 2026-09-01
NCT05831566
"Expertise Asthma COPD Program with Digital Support"; n 138; "Difference in percentage of patients treated with biologicals after 6 months of follow up"; 2026-04-30
NCT05839756
"Predicting Post Extubation Stridor After Maxillomandibular Fixation"; n 62; "Laryngeal air column width ratio"; 2028-06-30
NCT05915104
"Efficacy and Safety of Budesonide MMX® vs. Budesonide CR for Induction of Remission in Microscopic Colitis"; n 80; "Clinical remission"; 2026-12-31
NCT06076304
"Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Acute Sinusitis"; n 3720; "Symptom Improvement"; 2028-12
NCT06334575
"Molecular Signatures Associated With Response to ICS Treatment in Patients With COPD Stratified by Eosinophil Levels"; n 135; "Significant molecular changes in COPD stratified by their blood eosinophil counts."; 2027-12
NCT06429475
"Anti-Inflammatory Reliever South Africa"; n 1038; "Number of exacerbations in 52 weeks ( End of study)"; 2028-12-31
NCT06473779
"Open-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma."; n 326; "Proportion of patients who reduced their SYMBICORT® daily maintenance dose without the loss of asthma control at the end of the step-down phase."; 2027-06-25
NCT06535087
"The Impact of Airway Allergic Diseases on Children's and Parents' Quality of Life"; n 600; "Asthma control level for asthmatic children"; 2027-05-31
NCT06596252
"Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE"; n 308; "Proportion of patients in histological remission"; 2028-03
NCT06597682
"Evaluating Immunomodulatory Interventions in Post-Acute Sequelae of SARS-CoV-2 InfEction"; n 632; "Inflammatory Cardiac Involvement symptom cluster: cardiac magnetic resonance (CMR) indicators"; 2027-07
NCT06676319
"Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma"; n 556; "Annualized rate of asthma exacerbation events"; 2027-07-19
NCT06712407
"Efficacy and Safety of Extended TARPEYO® Treatment Beyond 9 Months in Adult Patients With Primary IgA Nephropathy"; n 60; "Ratio of Urine Protein to Creatine Ratio (UPCR) at 6 months compared to Baseline"; 2027-11
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which running trial of Budesonide could settle inflammatory markers?
NCT00576069 measures use exhaled nitric oxide as a surrogate marker of large airway vs small airway/lung inflammation following various doses of inhaled corticosteroids, reading out 2027-06.
1 open trial; n 60; "Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma"
Show the evidence
TrialNCT00576069
"Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma"; n 60; "use exhaled nitric oxide as a surrogate marker of large airway vs small airway/lung inflammation following various doses of inhaled corticosteroids"; 2027-06
Q10
Which 131 trials of Budesonide posted no result?
Posted no result
131 of 131 completed trials
Registrations
NCT00004842, NCT00641979, NCT00641914, NCT00641212, NCT00658255 and NCT00641680, and 125 more
Completion dates
oldest 1999-04; newest 2024-07-04
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Trial
NCT00004842
1999-04
NCT00641979
2002-08
NCT00641914
2003-02
NCT00641212
2003-04
NCT00658255
2003-05
NCT00641680
2003-07
14 further recorded trials
NCT00646009
2003-08
NCT00646620
2003-09
NCT00651651
2003-09
NCT00641446
2003-10
NCT00646529
2003-10
NCT00651547
2003-10
NCT00652002
2004-01
NCT00652392
2004-06
NCT00646321
2004-08
NCT00642161
2004-09
NCT00642187
2004-10
NCT00642122
2004-12
NCT00239278
2005-01
NCT00646594
2005-01
Q11
At the median, Budesonide's trials enrolled 83.5 people — anything larger?
Median enrolment
83.5
Largest enrolment
66581
Registered trials counted
324
Q12
What do 11346 spontaneous reports say about Budesonide — 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.
Budesonide appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 11346 reaction mentions were counted: dyspnoea 2651; asthma 2559; cough 1328; wheezing 1191. open-targets-adr · CHEMBL1370 · 2026-06-24
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dyspnoea
2651
asthma
2559
cough
1328
wheezing
1191
therapeutic product effect incomplete
747
chest discomfort
710
4 more recorded rows
poor quality device used
564
obstructive airways disorder
556
blood count abnormal
524
chronic obstructive pulmonary disease
516
recorded 2026-06-24 · last checked 2026-09-04
Q13
Budesonide and CYP3A4: shared by which compounds?
CYP3A4 appear in Budesonide's recorded interaction sentences, 2 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
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CYP3A4
pharmacokinetics
Two major metabolites formed via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4) catalyzed biotransformation have been isolated and identified as 16α-hydroxyprednisolone and 6β-hydroxybudesonide.
pharmacokinetics
Drug-Drug Interactions Inhibitors of cytochrome P450 enzymes : Ketoconazole: Ketoconazole, a strong inhibitor of cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4), the main metabolic enzyme for corticosteroids, increased plasma levels of orally ingested budesonide [see Warnings and Precautions ( 5.12 ), Drug Interactions ( 7.1 )].
recorded 2026-08-30 · last checked 2026-09-04
Q14
Was Budesonide studied with fasting and exercise?
fasting and exercise are named in Budesonide's label sentences: "Participants received a single oral dose of BOS 2 mg and a single oral dose of ENTOCORT EC 9 mg under fasting conditions in a randomized sequence, with a 48-h washout period between treatments." openfda-label+europepmc · 2026-08-30
2 recorded statements; fasting, exercise
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fasting
Participants received a single oral dose of BOS 2 mg and a single oral dose of ENTOCORT EC 9 mg under fasting conditions in a randomized sequence, with a 48-h washout period between treatments.
exercise
To evaluate the efficacy and safety of albuterol/budesonide compared with placebo in patients with asthma and exercise-induced bronchoconstriction (EIB).
recorded 2026-08-30 · last checked 2026-09-04
Q15
What is recorded about Budesonide and autophagy?
"Furthermore, the review summarizes potential therapeutic strategies targeting macrophage autophagy, such as budesonide/simvastatin combination therapy and rapamycin derivatives, along with their clinical translation prospects, with the aim of providing a theoretical foundation for developing novel, autophagy-targeted precision therapies…" — where Budesonide and autophagy appear together. Europe PMC · pathway abstract search · 2026-07-06
"Furthermore, the review summarizes potential therapeutic strategies targeting macrophage autophagy, such as budesonide/simvastatin combination therapy and rapamycin derivatives, along with their clinical translation prospects, with the aim of providing a theoretical foundation for developing novel, autophagy-targeted precision therapies for allergic diseases."
sirtuinPMID 31858575
"Budesonide combining Poractant Alfa can prevent BPD in preterm infants by activating the SIRT1 signaling pathway."
autophagy
PMID 33423318
"In asthmatic patients, inhaled budesonide inhibited airway macrophage autophagy (beclin-1, LC3) as well as autophagic flux (p62), which was enhanced by simvastatin and was correlated with increased sputum IL-10 and reduced IL-4 concentrations."
PMID 33423318
"In macrophages in vitro, budesonide and simvastatin inhibited rapamycin-induced autophagy as well as autophagic flux, with reduced expression of beclin-1 and LC3, but enhanced the accumulation of p62 and increased expression of IL-10, which itself further inhibited autophagy in macrophages."
mTOR
PMID 31269587
"<b>Objective:</b> To investigate the effect of different drugs on tracheal stenosis caused by transforming growth factor-β/rapamycin target protein (TGF-β/mTOR) signaling pathway. <b>Methods:</b> Thirty rabbits were randomly divided into normal control group, normal saline group, penicillin group, budesonide group and erythromycin group."
PMID 28100332
"Forty SPF level 6-8 week-old female Balb/C mice were randomly divided into control, asthma, budesonide and mTOR inhibitor (rapamycin) intervention groups (n=10 each)."
recorded 2026-07-06 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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