Novartis has announced positive data from a late-stage trial pitting its COPD inhaler Ultibro Breezhaler (indacaterol/glycopyrronium) against combination therapy with tiotropium and formoterol.
The Swiss drug giant said the study meet its primary endpoint of showing non-inferiority of Ultibro Breezhaler compared to tiotropium 18mcg/formoterol 12mcg in improving health-related quality of life outcomes in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
Also in the study, which included over 900 COPD patients, once-daily Ultibro Breezhaler induced superior improvements in lung function at 26 weeks compared to once-daily tiotropium plus twice-daily formoterol, while patients taking Novartis' inhaler were also more likely to demonstrate a clinically meaningful improvement in shortness of breath and health-related quality of life, the firm said.
Tim Wright, Global Head of Development at Novartis Pharmaceuticals, noted that the results "demonstrate that once-daily Ultibro Breezhaler can provide better symptom control versus a combination of two individual treatments, tiotropium plus formoterol".
Ultibro Breezhaler is a novel, once-daily dual bronchodilator approved as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD, which is predicted to become the third leading cause of death by 2020.