Triple Therapy ICS/LABA/LAMA — COPD Pregnancy: There are no or limited data in pregnant women; animal studies have shown reproductive toxicity. Glucocorticoids are known to cause effects in early gestation and beta2-sympathomimetics such as formoterol have tocolytic effects, so as a precautionary measure it is preferable to avoid use during pregnancy and during labour; use only if the expected benefit to the patient outweighs the potential risk to the foetus. Infants and neonates born to mothers receiving substantial doses should be observed for adrenal suppression. Breast-feeding: glucocorticoids are excreted in human milk and beclometasone dipropionate and its metabolites are presumed to be; formoterol and glycopyrronium have been detected in the milk of lactating animals, and anticholinergics such as glycopyrronium could suppress lactation.

Beclometasone / Formoterol / Glycopyrronium

Brand names: Trimbow

Used in: Asthma

This is a single-inhaler triple therapy combining beclometasone (inhaled corticosteroid), formoterol (long-acting beta-2 agonist) and glycopyrronium (long-acting muscarinic antagonist), used for maintenance treatment of COPD and, in some products, severe asthma.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Two inhalations twice daily

Route: Inhalation (breath-operated inhaler) — for inhalation use — source product: Trimbow NEXThaler (DPI) 88 micrograms/5 micrograms/9 micrograms per actuation inhalation powder

Frequency: Twice daily

Max: Two inhalations twice daily (stated as the maximum dose)

eMC SPC §4.2 (Trimbow) — 'The recommended dose is two inhalations twice daily. The maximum dose is two inhalations twice daily.' §4.2 does not state the inhaler strength — clinician to confirm. The retrieved SPC is the Trimbow inhalation powder (breath-operated, 120-dose counter) presentation; §4.8 compares its safety profile with the Trimbow pressurised solution. Elderly (65 years and over): no dose adjustment. Hepatic impairment: no relevant data in severe hepatic impairment (Child-Pugh class C) — use with caution. Paediatric: there is no relevant use in the paediatric population (under 18 years) for the indication of COPD. After each inhalation the patient should rinse the mouth or gargle with water without swallowing it, or brush the teeth. §4.4: not indicated for the treatment of acute episodes of bronchospasm or to treat an acute disease exacerbation (i.e. as rescue therapy); treatment should not be stopped abruptly. eMC §4.5 interactions was not retrieved in this bundle — the interaction listed below is stated within §4.4.

Dose adjustments

Renal

Can be used at the recommended dose in mild (GFR 50 to <80 mL/min/1.73 m2) to moderate (GFR 30 to <50 mL/min/1.73 m2) renal impairment. Use in severe renal impairment (GFR <30 mL/min/1.73 m2) or end-stage renal disease requiring dialysis (GFR <15 mL/min/1.73 m2), especially if associated with significant body weight reduction, should be considered only if the expected benefit outweighs the potential risk.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substances or to any of the excipients

Side effects

Dysphonia (0.3% in COPD, 1.5% in asthma) and oral candidiasis (0.8% in COPD, 0.3% in asthma) — common
Dry mouth (0.4% in COPD, 0.5% in asthma; 0.6% with the inhalation powder) and muscle spasms (0.4% and 0.2%) — uncommon/common as tabulated
Pneumonia in COPD patients, pharyngitis, urinary tract infection, nasopharyngitis (common)
Headache (common); tremor, dizziness, dysgeusia, hypoaesthesia (uncommon)
Atrial fibrillation, ECG QT prolonged, tachycardia, tachyarrhythmia, palpitations (uncommon); angina pectoris, ventricular and supraventricular extrasystoles, nodal rhythm (rare)
Hypokalaemia and hyperglycaemia (uncommon); hypersensitivity reactions including erythema and oedema of lips, face, eye and pharynx (rare); adrenal suppression, glaucoma, cataract (very rare)

Interactions

Halogenated anaesthetics — ensure Trimbow is not administered for at least 12 hours before the start of anaesthesia, because of the risk of cardiac arrhythmias (§4.4)

Clinical monograph

How it works

Beclometasone dampens airway inflammation, formoterol relaxes bronchial smooth muscle via beta-2 receptors, and glycopyrronium produces additional bronchodilation by blocking muscarinic receptors.

Prescribing in practice

Most important: reserve triple therapy for patients inadequately controlled on dual therapy and review pneumonia risk, as the inhaled corticosteroid component increases pneumonia incidence in COPD.
Use the antimuscarinic with caution in symptomatic prostatic hyperplasia, bladder-outflow obstruction and narrow-angle glaucoma.
Ensure the patient is not also taking a separate LABA or LAMA to avoid duplicate long-acting bronchodilator exposure.

Monitoring

Monitor COPD control and exacerbations, watch for pneumonia, and review cardiovascular symptoms and anticholinergic side effects.

Counselling the patient

Rinse the mouth after each dose to reduce oral thrush.
Report worsening breathlessness with fever or new urinary difficulty, and use it every day as prescribed.

Evidence & guidelines

Single-inhaler triple therapy is supported by trials showing reduced exacerbations versus dual therapy in COPD and is reflected in GOLD and NICE guidance.

Reference: KRONOS Trial (Ferguson et al. Lancet Resp Med 2018); GOLD 2024; NICE NG115; SPC Trimbow; 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).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways