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ICS/LAMA/LABA triple inhaler Pregnancy: SPC 4.6: Pregnancy - limited data from the use of fluticasone furoate/umeclidinium/vilanterol in pregnant women; animal studies have shown reproductive toxicity at exposures which are not clinically relevant; administration to pregnant women should only be considered if the expected benefit to the mother justifies the potential risk to the foetus. Breast-feeding - unknown whether the active substances or their metabolites are excreted in human milk, but other corticosteroids, muscarinic antagonists and beta2-adrenergic agonists are detected in human milk and a risk to newborns/infants cannot be excluded; a decision must be made whether to discontinue breast-feeding or to discontinue therapy. Fertility - no human data; animal studies indicate no effects on male or female fertility.

Fluticasone with umeclidinium and vilanterol

Brand names: Trelegy Ellipta

This is single-inhaler triple therapy combining inhaled corticosteroid fluticasone furoate, long-acting muscarinic antagonist umeclidinium and long-acting beta2 agonist vilanterol, taken once daily for maintenance treatment of COPD and severe asthma.

Adult dose

Dose: Trelegy Ellipta 92/55/22 micrograms inhalation powder, pre-dispensed (each delivered inhalation: fluticasone furoate 92 micrograms, umeclidinium 55 micrograms, vilanterol 22 micrograms) - maintenance treatment in adults with moderate to severe COPD who are not adequately treated by an inhaled corticosteroid plus long-acting beta2-agonist or a long-acting beta2-agonist plus long-acting muscarinic antagonist: one inhalation once daily, each day at the same time
Route: Inhaled (oral inhalation, Ellipta dry-powder inhaler)
Frequency: Once daily, at the same time each day. If a dose is missed, inhale the next dose at the usual time the next day
Max: One inhalation once daily (the SPC states this is both the recommended and the maximum dose)
SOURCE: UK SPC for ONE product - Trelegy Ellipta 92/55/22 micrograms inhalation powder, pre-dispensed (PLGB194940287, GlaxoSmithKline UK Limited). SPC 4.2 verbatim: 'The recommended and maximum dose is one inhalation once daily, each day at the same time.' SCOPE - THIS 92/55/22 PRODUCT IS LICENSED FOR COPD ONLY: 4.1 gives COPD as the only indication, and 4.4 states 'This medicinal product should not be used in patients with asthma since it has not been studied in this patient population.' This card therefore gives NO asthma dose; any asthma-strength Trelegy Ellipta product and any other fluticasone/umeclidinium/vilanterol or other ICS/LAMA/LABA product has its own SPC, differs, and is not covered here. NOT FOR ACUTE USE (4.4): no clinical data support use for acute bronchospasm or an acute COPD exacerbation (i.e. as rescue therapy); increasing use of short-acting bronchodilators may indicate deterioration of disease control - re-evaluate the patient and the COPD treatment regimen; patients should not stop therapy without physician supervision since symptoms may recur. SPECIAL POPULATIONS (4.2): no dose adjustment in patients 65 years of age or older, in renal impairment, or in mild, moderate or severe hepatic impairment (use with caution in moderate to severe hepatic impairment). CHILDREN (4.2): 'There is no relevant use of Trelegy Ellipta in the paediatric population (under 18 years of age) for the indication of COPD', so no paediatric dose is given. METHOD (4.2): for inhalation use only; open the cover until a click is heard (the dose counter counts down by 1; if it does not, the inhaler will not deliver a dose and should be taken back to a pharmacist); do not shake; breathe out away from the inhaler, close the lips around the mouthpiece without blocking the air vents, inhale with one long, steady, deep breath and hold it for as long as possible (at least 3-4 seconds); then rinse the mouth with water without swallowing to make a sore mouth or throat less likely. Contains lactose. Some sections of the product information we used were incomplete — check the full SPC.

Dose adjustments

Renal

No dose adjustment is required in patients with renal impairment (4.2).

Hepatic

No dose adjustment is required in mild, moderate or severe hepatic impairment; use with caution in moderate to severe hepatic impairment, and monitor those patients for systemic corticosteroid-related adverse reactions (4.2, 4.4).

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via MHRA Products — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substances or to any of the excipients listed in section 6.1

Side effects

  • Common: pneumonia, upper respiratory tract infection, bronchitis, pharyngitis, rhinitis, sinusitis, influenza, nasopharyngitis, candidiasis of mouth and throat, urinary tract infection, headache, cough, oropharyngeal pain, constipation, arthralgia, back pain
  • Uncommon: viral respiratory tract infection, dysgeusia, vision blurred, glaucoma, eye pain, supraventricular tachyarrhythmia, tachycardia, atrial fibrillation, dysphonia, dry mouth, fractures
  • Rare: hypersensitivity reactions (including anaphylaxis, angioedema, urticaria and rash), hyperglycaemia, anxiety, tremor, intraocular pressure increased, palpitations, muscle spasms, urinary retention, dysuria
  • Most frequently reported: nasopharyngitis (7%), headache (5%), upper respiratory tract infection (2%)
  • Increased incidence of pneumonia (including pneumonia requiring hospitalisation) observed in COPD patients receiving inhaled corticosteroids; paradoxical bronchospasm may occur (4.4)

Interactions

  • Beta-blockers: beta2-adrenergic blockers may weaken or antagonise the effect of vilanterol; if required consider cardioselective beta-blockers, with caution for both non-selective and selective agents
  • Strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir, cobicistat-containing products): increased systemic exposure to fluticasone furoate and vilanterol - avoid co-administration unless the benefit outweighs the increased risk of systemic corticosteroid adverse reactions, in which case monitor for them
  • Other medicinal products that can cause hypokalaemia: use with caution (beta2-agonists may produce significant hypokalaemia)
  • CYP2D6 inhibitors / CYP2D6 poor metabolisers: no clinically relevant interaction expected with umeclidinium

Monitoring

  • Re-evaluate the patient and the COPD treatment regimen if COPD deteriorates or short-acting bronchodilator use increases
  • Patients with moderate to severe hepatic impairment: monitor for systemic corticosteroid-related adverse reactions
  • Diabetic patients: monitor plasma glucose more closely when treatment is started
  • Remain vigilant for pneumonia in COPD patients (risk factors: current smoking, older age, low BMI, severe COPD)
  • Visual disturbance (e.g. blurred vision): consider referral to an ophthalmologist to evaluate possible causes such as cataract, glaucoma or central serous chorioretinopathy
  • Use with caution in unstable or life-threatening cardiovascular disease, narrow-angle glaucoma, urinary retention or risk factors for it (e.g. benign prostatic hypertrophy), convulsive disorders, thyrotoxicosis, pulmonary tuberculosis and chronic or untreated infections

Clinical monograph

How it works

Fluticasone furoate reduces airway inflammation, umeclidinium provides sustained bronchodilation by antagonising muscarinic receptors, and vilanterol relaxes airway smooth muscle through beta2 adrenoceptor stimulation.

Prescribing in practice

  • It is a once-daily maintenance treatment only and must never be used for acute symptom relief, which requires a separate short-acting reliever.
  • The inhaled corticosteroid increases pneumonia risk in COPD, and the antimuscarinic component warrants caution in closed-angle glaucoma and bladder outflow obstruction.
  • Avoid co-prescribing other long-acting bronchodilators or inhaled corticosteroids to prevent duplication and additive cardiovascular and antimuscarinic effects.

Monitoring

Monitor symptom control, inhaler technique and adherence, with vigilance for pneumonia in COPD, candidiasis, and antimuscarinic adverse effects.

Counselling the patient

  • Use once every day as a preventer, not for sudden breathlessness.
  • Rinse the mouth after inhaling to reduce thrush and hoarseness.
  • Report fever, worsening breathlessness, eye pain or difficulty passing urine.

Evidence & guidelines

Single-inhaler triple therapy is supported by COPD outcome trials demonstrating fewer exacerbations than dual therapy and is recommended in NICE guidance for selected patients.

Reference: NICE NG115/NG80; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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