TriOptimize III: Extrafine single inhaler Triple Therapy in COPD improves health-related quality of life in a real-world setting in Germany

 

Background: Recently, randomized, controlled clinical trials demonstrated beneficial therapeutic effects of single inhaler triple therapy (SITT) consisting of extrafine beclomethasone dipropionate (BDP), formoterol fumarate (FF) and glycopyrronium (G) in the treatment of patients with severe to very severe COPD at risk of exacerbations. SITT with BDP/FF/G significantly reduced exacerbation rates compared to a therapy with a LAMA, an ICS/LABA combination or a LAMA/LABA combination. TriOptimize is the first prospective observational non-interventional study, aiming to evaluate the changes in health-related quality of life (HRQoL) as measured by the COPD assessment Test (CAT) in patients with moderate-severe COPD and a history of ≥ 1 exacerbation in the previous 12 months, after treatment with extrafine BDP/FF/G therapy for 6 months in a real-world setting in Germany. Here, we present the improvement of HRQoL in the first 1017 patients who completed the study.

Results: At study entry, the average age was 66 years, the BMI was 27.3, and 55% were males. 61.3% of patients were former smokers (average number of pack years: 41.4) and 38.7% were current smokers (average number of pack years: 44.8). The average time since COPD diagnosis was 7.4 years. Before switching to SITT, most patients (70.4%) received a multi-inhaler triple therapy (MTT) consisting of ICS+LABA+LAMA, whilst 27,3% were on ICS/LABA treatment. The average CAT score at baseline in the overall patient population was 21.0 which improved significantly after 6 months of treatment with extrafine SITT to 19.0 (p < 0.0001), meeting the MCID of − 2 points. The CAT score improvement was more pronounced in the group of patients on prior ICS/LABA, with an improvement of − 2.8 (p < 0.0001). A total of 197 adverse drug reactions were reported with no unexpected, new or fatal drug related events identified.

Summary: These results indicate that in a real-world setting, extrafine SITT with BDP/FF/G is effective in improving HRQoL measured by CAT in a population of patients with moderate to severe COPD, on prior ICS/LABA or MITT, confirming the positive results of the pivotal trials. Further analysis of this study will include patients on prior LAMA/LABA therapy and factors such as adherence and lung function.