- Ultibro Breezhaler provided significant improvements in cardiac and lung function in COPD patients with lung hyperinflation, compared to placebo
- CLAIM is the first study to investigate the effect of dual bronchodilation on cardiac function
- Data published in the Lancet Respiratory Medicine
Basel, February 22, 2018 - Novartis today announced the publication of the CLAIM* study in the Lancet Respiratory Medicine, which demonstrated that treatment once-daily Ultibro Breezhaler (indacaterol/glycopyrronium 110/50 mcg) significantly improved lung and cardiac function, when compared to placebo, in chronic obstructive pulmonary disease (COPD) patients with lung hyperinflation.
Many people living with COPD are at increased risk of death and disability due to comorbid cardiovascular disease. Lung hyperinflation is common in people with COPD , and has been linked to impaired cardiac function and a worsening of COPD symptoms, especially breathlessness - . CLAIM is the first study to investigate the effects of dual bronchodilation on cardiac function and lung hyperinflation.
The CLAIM study met its primary endpoint demonstrating that treatment with Ultibro Breezhaler led to decreased lung hyperinflation and improvements in cardiac function** after 14 days of treatment. This translated into clinically relevant patient benefits of improved health status and breathlessness (dyspnea), studied as exploratory endpoints.
"Lung hyperinflation is often associated with impaired cardiac function in patients with COPD," said Shreeram Aradhye, Chief Medical Officer and Global Head of Medical Affairs for Novartis Pharmaceuticals. "The publication of the CLAIM study is important for any COPD patient with signs of lung hyperinflation. For the first time, we demonstrated that treatment with Ultibro Breezhaler can reduce lung hyperinflation and improve cardiac function, breathlessness and health status."
In the CLAIM study Ultibro Breezhaler was well tolerated and its safety profile was comparable with placebo.
About the CLAIM study
The CLAIM study was a randomized, double-blinded, placebo-controlled, single-center, two period cross-over study comparing the effects of 14-day Ultibro Breezhaler therapy with placebo on cardiac and lung function in hyperinflated COPD patients. It involved a total of 62 patients, of whom 57 completed both treatment periods. All patients had moderate-to-very severe COPD and confirmed lung hyperinflation (residual volume >135% predicted).
The primary endpoint of the study was to demonstrate the effect of 14-day once-daily Ultibro Breezhaler treatment on left ventricular end-diastolic volume (LV-EDV) as measured by MRI. Secondary endpoints included effects on lung function parameters as measured by residual volume (RVol), forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) .
Cardiac assessments included right ventricular end-diastolic volume (RV-EDV), left and right ventricular stroke volume (LV-SV and RV-SV), left and right ventricular end-systolic volumes (LV-ESV and RV-ESV) and cardiac index (CI) .
About Ultibro Breezhaler
Ultibro Breezhaler 110/50 mcg is a once-daily LABA***/LAMA**** dual bronchodilator approved in the European Union (EU) as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. Clinical trials have shown that it provides significant improvements in bronchodilation compared to treatments widely used as current standards of care, including salmeterol/fluticasone 50/500 mcg and open-label tiotropium (18 mcg) - . Ultibro Breezhaler is currently approved for use in over 100 countries worldwide, including countries within the EU and Latin America, Japan, Canada, Switzerland and Australia.
About the Novartis COPD portfolio
Novartis is committed to addressing the unmet medical needs of COPD patients and improving their quality of life by providing innovative medicines and devices. The Novartis COPD portfolio includes Ultibro Breezhaler (indacaterol/glycopyrronium bromide), Seebri Breezhaler (glycopyrronium bromide) and Onbrez Breezhaler (indacaterol), which are all indicated as maintenance treatments for COPD patients. Glycopyrronium bromide and certain use and formulation intellectual property were exclusively licensed to Novartis in April 2005 by Sosei and Vectura.
Novartis continues development of respiratory products for delivery via the low resistance Breezhaler inhalation device, which makes it suitable for patients with different severities of airflow limitation. The Breezhaler device allows patients to hear, feel and see that they have taken the full dose correctly , .
COPD affects an estimated 210 million people worldwide and is the fourth leading cause of death. It is progressive (usually gets worse over time) and can be a life-threatening disease , . COPD makes it difficult to breathe, with symptoms that have a destructive impact on patients’ function (i.e. activity limitation, decreased mobility) and quality of life , .
Lung hyperinflation occurs in a significant proportion of patients with COPD. It occurs as a result of air trapping, due to airway obstruction. Hyperinflation causes increased breathlessness and can affect the health status of people with COPD.