TRIMBOW (beclometasone / formoterol / glycopyrronium), combination of inhaled corticosteroid (ICS), long-acting beta-2-agonist (LABA) bronchodilator and long-acting muscarinic antagonist (LAMA) bronchodilator

RESPIRATORY MEDICINE - New medicinal product
Opinions on drugs - Posted on Jul 06 2018

Reason for request

Inclusion

Low clinical benefit for the treatment of severe chronic obstructive pulmonary disease (COPD) in adults not treated satisfactorily with the combination of an inhaled corticosteroid and a long-acting beta-2-agonist bronchodilator and no proven clinical added value for the therapeutic strategy

Insufficient clinical benefit for the treatment of moderate COPD

 

  • TRIMBOW, a fixed combination of beclometasone 87 µg/ formoterol 5 µg/ glycopyrronium 9 µg (ICS + LABA+ LAMA), has been granted a marketing authorisation for the long-term treatment of moderate to severe chronic obstructive pulmonary disease (COPD) in adults not treated satisfactorily with an ICS/LABA combination.

  • It helps simplify treatment for patients with severe forms of the disease requiring inhaled triple therapy combining two long-acting bronchodilators (LABA + LAMA) and an ICS.

  • TRIMBOW was statistically superior to a beclometasone/formoterol (ICS + LABA) combination in terms of FEV1, incidence of exacerbations and quality of life, but the differences were modest.

 

 


Clinical Benefit

Low

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Insufficient

Clinical Added Value

no clinical added value

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