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LABA/LAMA Dual Bronchodilator — COPD Pregnancy: Not applicable — COPD in pregnancy: seek specialist respiratory input

Indacaterol / Glycopyrronium

Brand names: Ultibro Breezhaler

Adult dose

Dose: 85/43 mcg once daily (1 inhalation)
Route: Inhaled (Breezhaler DPI)
Frequency: Once daily
Max: 1 inhalation once daily
Dual LABA (indacaterol) + LAMA (glycopyrronium) bronchodilator for symptomatic COPD without frequent exacerbations. First-line maintenance treatment in COPD patients with predominant breathlessness (GOLD groups A and B). Breezhaler capsule device — delivers audible 'click' confirming inhalation.

Paediatric dose

Dose: Not applicable mcg/kg
Route: Inhaled
Frequency: Once daily
Max: Not applicable
Not licensed in children

Dose adjustments

Renal

No dose adjustment required in mild-moderate renal impairment; use with caution in severe impairment

Hepatic

No dose adjustment in mild-moderate hepatic impairment

Paediatric weight-based calculator

Not licensed in children

Clinical pearls

  • FLAME trial: indacaterol/glycopyrronium (Ultibro) superior to ICS/LABA (salmeterol/fluticasone) in preventing exacerbations in COPD — key evidence supporting LAMA/LABA over ICS/LABA as first-line dual therapy in COPD
  • GOLD 2024: LAMA/LABA is preferred dual bronchodilator combination in COPD — superior to LAMA alone or LABA alone in symptom relief and exacerbation prevention
  • Breezhaler device: capsule-based — patient must pierce capsule correctly; audible whirring sound confirms inhalation; common error is swallowing the capsule
  • Not interchangeable with Anoro Ellipta (umeclidinium/vilanterol) or Spiolto Respimat (tiotropium/olodaterol) — different molecules, not bioequivalent
  • COPD diagnosis must be confirmed by post-bronchodilator spirometry (FEV1/FVC <0.70) before starting maintenance therapy — do not treat symptomatically without confirmed diagnosis

Contraindications

  • Asthma (not licensed — LABA monotherapy without ICS)
  • Acute bronchospasm
  • Hypersensitivity to indacaterol or glycopyrronium

Side effects

  • Nasopharyngitis
  • Cough on inhalation (from capsule/powder)
  • Dry mouth (anticholinergic)
  • Urinary retention (anticholinergic)
  • Constipation
  • Palpitations

Interactions

  • Beta-blockers — antagonise indacaterol
  • Other anticholinergics — additive effects
  • QT-prolonging drugs — additive risk (rare at inhaled doses)

Monitoring

  • mMRC dyspnoea score
  • CAT score (COPD Assessment Test)
  • FEV1 annually
  • Exacerbation frequency

Reference: BNFc; BNF 90; FLAME Trial (Wedzicha et al. NEJM 2016); GOLD 2024; NICE NG115; SPC Ultibro Breezhaler. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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