Innovative clinical study: a successful step in COPD research

February 22, 2018

In a clinical trial performed at the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, administration of a combination drug from Novartis (indacaterol/glycopyrronium) was shown to improve not only lung function in COPD patients, but to have a significantly positive effect on their heart function as well. The results of this study have now been published in the renowned journal “The Lancet Respiratory Medicine”.

In Germany, about 13 percent of the population suffer from chronic obstructive pulmonary disease (COPD). COPD is the fourth leading cause of death worldwide, with 90 percent of patients being smokers. Coughing, mucus production and shortness of breath, resulting from progressive airway obstruction and hyperinflated lungs, are typical symptoms of this disease. Long-acting bronchodilator combination drugs such as beta-mimetics and anti-muscarinics represent the most important pillar of treatment in the advanced stage of COPD.

Great success in COPD research: An innovative clinical study performed by Fraunhofer ITEM has shown the drug under investigation to improve not only lung function in COPD patients, but to have a significantly positive effect on their heart function as well. The study investigated a combination drug from Novartis Pharma AG (incacaterol/glycopyrronium) that has already been approved for COPD treatment. The results were published in the renowned journal “The Lancet Respiratory Medicine“.
Fraunhofer ITEM researchers used magnetic resonance imaging to investigate the effects of the combination drug on patients’ heart function at the CRC Hannover.

In collaboration with the Institute for Radiology and the Clinics for Respiratory Medicine and Cardiology of the Hannover Medical School (MHH), Fraunhofer ITEM scientists used magnetic resonance imaging of the heart to investigate whether 14-day treatment with a long-acting combination drug from Novartis, approved already for COPD treatment, would result in improved function not only of the lung, but also of the heart. In a placebo-controlled, double-blind clinical trial, they examined 62 patients over 40 with moderate to severe COPD and hyperinflated lungs.

Compared with placebo, the treatment was shown to lead to highly significant and clinically relevant improvement of the hyperinflation and airway obstruction. Furthermore, left and right cardiac filling volumes were found to have substantially increased, resulting in improved cardiac output. The treatment led to a significant improvement of symptoms and quality of life for the patients. These results are important for the therapy of COPD, suggesting that the investigated treatment does not only improve lung function, but also leads to a clinically relevant improvement of heart function in COPD patients with hyperinflated lungs. Professor Jens Hohlfeld, principal investigator of this study and Head of Clinical Airway Research at Fraunhofer ITEM, explains, “This impressive result is a collaborative success: it was the combination of Fraunhofer ITEM’s long expertise in airway research and the expertise of Professors Jens Vogel-Claussen, Johann Bauersachs and Tobias Welte of the Hannover Medical School that has enabled these findings. In addition, in the Clinical Research Center Hannover we have leading-edge equipment for clinical research available, a prerequisite for such innovative studies. In this regard, we are almost unrivaled among the clinical research centers in Germany.”

Read the publication in the journal “The Lancet Respiratory Medicine”


Prof. Dr. med. Jens Hohlfeld
Fraunhofer ITEM
Phone +49 511 5350-8101
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