TRIMBOW (bromure de glycopyrronium/ dipropionate de béclométasone/ fumarate de ...)

PULMONOLOGY - New medicinal product
Opinions on drugs - Posted on Apr 03 2020

Reason for request

Re-assesment of the Clinical benefit

Moderate clinical benefit in the treatment of adult patients with severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid (ICS) and a long-acting beta2-agonist (LABA) or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist (LAMA) and no demonstrated clinical added value in the care pathway

Insufficient clinical benefit in the treatment of moderate COPD

  • TRIMBOW has an MA for maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an ICS and a LABA or a combination of a LABA and a LAMA.
  • It simplifies the treatment of patients with severe disease, requiring triple inhaled therapy combining two long-acting bronchodilators (LABA + LAMA) with an ICS.
  • TRIMBOW was statistically superior to an ICS/LABA or LAMA/LAMA combination for the occurrence of exacerbations, the forced expiratory volume per second (FEV1) and quality of life, but the differences were modest.

Clinical Benefit

Moderate

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Insufficient