COPD
Trimbow has been shown to be effective at relieving symptoms of COPD in three main studies involving over 5,500 patients whose symptoms were not controlled well enough either by combinations of two other COPD medicines or by a long-acting muscarinic receptor antagonist alone. 

In the first study lasting a year, after 26 weeks of treatment Trimbow improved patients’ FEV1 (the maximum volume of air a person can breathe out in one second) by 82 ml before a dose and 261 ml after a dose. By comparison, the FEV1 increased by 1 and 145 ml before and after dosing in patients treated with a medicine containing only 2 of the active substances found in Trimbow (beclometasone plus formoterol). 

In the second study lasting a year, patients treated with Trimbow had 20% fewer exacerbations (flare-ups of symptoms) a year than patients treated with tiotropium (a long-acting muscarinic receptor antagonist). In this study, Trimbow was as effective as tiotropium plus a combination of beclometasone and formoterol at reducing the number of exacerbations.

In the third study lasting a year, patients treated with Trimbow had 15% fewer exacerbations a year than patients treated with a combination of indacaterol (a long-acting beta-2 agonist) and glycopyrronium bromide. 

Asthma
A main study involved over 1,000 patients with asthma whose disease was not adequately controlled on medium doses of inhaled corticosteroids in combination with long-acting beta-2 agonists. Patients had at least one asthma exacerbation in the previous year. After 26 weeks of treatment, Trimbow (medium strength) improved patients’ FEV1 before dosing by 185 ml compared with 127 ml with a combination of beclometasone plus formoterol. In addition, patients treated with Trimbow for up to one year had 15% fewer moderate and severe exacerbations a year than patients treated with beclometasone plus formoterol.

In a second study in over 1,000 patients with asthma whose disease was not adequately controlled on high doses of inhaled corticosteroids in combination with long-acting beta-2 agonists, Trimbow (higher strength) improved patients’ FEV1 before dosing by 229 ml compared with 157 ml for beclometasone plus formoterol after 26 weeks of treatment. The 12% reduction in the yearly rate of moderate to severe exacerbations was not statistically different (meaning that it may be due to chance) between the 2 groups. However, a higher reduction in the number of these exacerbations per year was seen with Trimbow in a sub-group of patients with persistent airflow limitation, representing almost two thirds of patients analysed. When looking at the results from the 2 studies together, Trimbow was found to have a beneficial effect on the rate of severe exacerbations.