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Lung deflation and improvement of cardiac end-diastolic volumes with indacaterol/glycopyrronium reduce dyspnea and improve health status in hyperinflated COPD patients: The CLAIM study

: Hohlfeld, Jens M.; Vogel-Claussen, Jens; Biller, Heike; Berliner, Dominik; Berschneider, Korbinian; Tillmann, Hanns-Christian; Hiltl, Simone; Bauersachs, Johann; Welte, Tobias

American Journal of Respiratory and Critical Care Medicine 197 (2018), Abstract A4244
ISSN: 1073-449X
ISSN: 0003-0805
ISSN: 1535-4970
American Thoracic Society (ATS International Conference) <2018, San Diego/Calif.>
Fraunhofer ITEM ()

Rationale Cardiovascular diseases such as heart failure are common comorbidities of chronic obstructive pulmonary disease (COPD) and have a significant impact on morbidity and mortality. Lung hyperinflation detrimentally affects cardiac function in COPD patients and pharmacological deflation of the lung improves lung function and cardiac end-diastolic volumes. Here we show the effect of lung deflation and subsequent improvement of cardiac function on patient reported outcomes such as health status and symptoms in hyperinflated COPD patients. Methods In this randomized, double-blind, single-center, placebo-controlled, 2 period cross-over trial, COPD patients with increased residual volume (RV > 135 % pred.) and without relevant cardiovascular disease were enrolled. Primary outcome was the change in left-ventricular end-diastolic volume (LVEDV) measured with MRI after 14 days of treatment with indacaterol/glycopyrronium (IND/GLY, 110/50 µg q.d.) or placebo. Health status was assessed using the COPD assessment test (CAT) score and dyspnea was assessed with the baseline/transition dyspnea index (BDI/TDI) score. Results 62 patients were randomized, of which 57 completed both treatment periods. Treatment with IND/GLY significantly increased cardiac end-diastolic volumes, cardiac output and lung function measures vs. placebo. Improvement of end-diastolic volumes and lung function was associated with a statistical significant and clinically relevant increase in CAT and TDI scores. Changes in both scores remarkably exceeded the minimal clinically important difference after 14 days of treatment with LS means treatment differences versus placebo of -3.6 points (95% CI: -5.1, -2.2; P<0.0001) in CAT score and +3.7 points (95% CI: 2.5, 4.8; P<0.0001) in TDI. The safety profile of IND/GLY was comparable to placebo. Conclusion Lung deflation with dual bronchodilation using IND/GLY substantially improved cardiac function with increase in right- and left-ventricular end-diastolic volumes and cardiac output in hyperinflated COPD patients. This study is the first to show that lung deflation and improvement in cardiac function translate into a clinically relevant reduction of disease burden and dyspnea. Our findings argue for the early use of dual bronchodilation in patients with COPD who show signs of hyperinflation.