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 |
- |
Insufficient |
Clinical Added Value
no clinical added value |
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