Novartis’ Ultibro Breezhaler provided noteworthy improvements in cardiac and lung function in chronic obstructive pulmonary disease (COPD) patients with lung hyperinflation (overinflated lungs) when compared to placebo, a new research study found.
The study reporting the findings, “Effect of lung deflation with indacaterol plus glycopyrronium on ventricular filling in patients with hyperinflation and COPD (CLAIM): a double-blind, randomised, crossover, placebo-controlled, single-centre trial,” was published in The Lancet Respiratory Medicine.
Ultibro Breezhaler (indacaterol/glycopyrronium 110/50 mcg) is a long-acting beta adrenergic agonist (LABA) and long-acting muscarinic antagonist (LAMA) dual bronchodilator that has been shown to have superior effectiveness compared to widely used treatments in reducing mild, moderate and severe COPD exacerbations.
Patients with COPD are at increased risk of disability and death due to cardiovascular diseases. COPD, coronary artery disease, congestive heart failure, and cardiac arrhythmias have a strong influence on each other, most likely due to systemic inflammation.
The new study, funded by Novartis, comprises the findings from the Phase 4 CLAIM trial (NCT02442206), which, according to the research team, is the first trial to investigate the effect of dual bronchodilation on cardiac function and lung hyperinflation.
CLAIM was a randomized, two-period cross-over study that compared the effects of 14-day Ultibro Breezhaler treatment with placebo in a total of 62 patients with moderate-to-very-severe COPD and confirmed lung hyperinflation.
The study was conducted at the Fraunhofer Institute of Toxicology and Experimental Medicine in Hannover, Germany. Eligible participants were at least 40 years old, had a smoking history of at least 10 pack-years, and airflow limitation.
Patients were randomly assigned (1:1) to either receive Ultibro Breezhaler once daily for 14 days, followed by a 14-day washout period and then a matched placebo for another 14 days, or to receive the same treatment in reverse order. Of 62 patients, 57 completed the study.
Results showed that Ultibro Breezhaler led to decreased lung hyperinflation and improvements in cardiac function after 14 days of treatment.
These results translated into clinically relevant benefits for patients regarding improved health status and breathlessness.
The treatment also was well-tolerated, with a safety profile comparable to placebo. The most commonly reported adverse events were cough (nine patients) and throat irritation (seven patients).
“Lung hyperinflation is often associated with impaired cardiac function in patients with COPD. 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.” Shreeram Aradhye, chief medical officer and global head of medical affairs for Novartis, said in a press release.
Ultibro Breezhaler is approved in more than 100 countries as a maintenance treatment to relieve symptoms of COPD in adult patients.