Chiesi Group has announced data from two Phase III studies, TRIMARAN and TRIGGER, the first studies to evaluate the relative efficacy and safety of extrafine formulation single-inhaler triple therapy compared with extrafine formulation inhaled corticosteroid (ICS) and long-acting β2 agonist (LABA) in adults with asthma.
The data, published in The Lancet, showed that at week 26 the combination had achieved one of its co-primary endpoints, and a 15% and 12% reduction in the moderate-to-severe exacerbation rate was achieved over 52 weeks.
Furthermore, in the key secondary endpoint analysis of data pooled from both studies, the long-acting β2 agonist arm reduced the annualised rate of severe exacerbations by 23%, the rate of moderate exacerbations by 12% and combined moderate and severe exacerbations by 14%.
Professor J. Christian Virchow, one of the principal investigators of the TRIMARAN and TRIGGER studies, reminded that some patients with uncontrolled asthma are “required to use two different inhalers, of different design and with different instructions for use – and often with different dosing regimens.”
He went on to say that this system is “not only inconvenient for patients and healthcare providers who provide instruction on correct inhaler use but can negatively impact treatment adherence and persistence, leading to poor disease control. So, these findings are exciting for patients and healthcare providers alike because they provide first time evidence of the potential benefits of a single-inhaler triple combination of BDP/FF/G for those with uncontrolled asthma.”
Asthma is a common long-term condition that can affect people of all ages and causes inflammation in the airways. Difficult-to-treat or severe versions of the disease occurs in 24% of patients.