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UK-RES-2101606 August 2021

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UK-RES-2101574 August 2021

INTENDED FOR UK HEALTHCARE PROFESSIONALS ONLY

Trimbow – Evidence Summary

Indication[[1]]

Trimbow pMDI 87/5/9 is indicated for the maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid, and who experienced one or more asthma exacerbations in the previous year.1

Three compounds[[1]]

Beclometasone1
Beclometasone given by inhalation is a corticosteroid with glucocorticoid anti-inflammatory action which suppresses inflammation in the lungs.

Formoterol1
Formoterol is a selective β2-adrenergic agonist that produces relaxation of bronchial smooth muscle in patients with reversible airways obstruction. The bronchodilating effect sets in rapidly, within 1–3 minutes after inhalation, and has a duration of 12 hours after a single dose.

Glycopyrronium1
Glycopyrronium is a high-affinity, long-acting muscarinic receptor antagonist (anticholinergic) resulting in a bronchodilator effect on the lungs.

Trimbow pMDI 87/5/9 Clinical Trial[[2]]

TRIMARAN was a randomised (1:1), double-blind, multinational, active-controlled 2-arm parallel group study2

TRIMARAN study design overview2

Aim Compared Trimbow pMDI 87/5/9 2 puffs b.d. with medium dose Fostair (beclometasone/formoterol) pMDI 100/6 2 puffs b.d. in patients with asthma that were poorly controlled on medium-dose ICS/LABA therapy
Duration 52-week treatment period
Co-primary endpoints

●       Pre-dose morning FEV1 at week 26

●       Rate of moderate and severe exacerbations over 52 weeks




TRIMARAN study key results

  • 15% reduction in rate of moderate and severe exacerbations vs. Fostair pMDI 100/6 (Annualised rate: 1.83 vs. 2.16 respectively [ARR 0.33, RR 0.85, p=0.033])2
  • 57 mL improvement in pre-dose morning FEV1 vs. Fostair pMDI 100/6 (Change from baseline: 185 mL vs. 127 mL respectively [p=0.008])2

 

 

Safety and tolerability[[2]]

TRIMARAN study safety and tolerability2

To request a visit from a Chiesi representative to learn more about Trimbow, please click here.

For additional information to share with your patients who have been prescribed Trimbow, please visit our Trimbow patient and carer site.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Chiesi Limited on 0800 0092329 (UK) or PV.UK@Chiesi.com.