Patients who switched to Ultibro Breezhaler had an increase in lung function.
Novartis announced positive findings from a large-scale clinical trial that explored the consequences of switching treatments for symptomatic, non-frequently exacerbating patients with moderate chronic obstructive pulmonary disorder (COPD). These findings were presented at the 2016 British Thoracic Society Winter Meeting.
In the CRYSTAL study, patients were switched from older treatments to Novartis’s dual bronchodilator Ultibro Breezhaler (indacaterol/glycopyrronium) 110/50 mcg or to Seebri Breezhaler (glycopyrronium) 50 mcg, according to a press release from the company. Patients were randomized to receive the new treatments or continue on their current treatment based on previous medication and symptoms.
At baseline, patients were receiving treatment with a long-acting beta-adrenoceptor antagonist plus inhaled corticosteroid, long-acting beta-adrenoceptor antagonist monotherapy, or long-acting muscarinic antagonist.
Of the 4389 patients included, a total of 2159 patients received treatment with Ultibro Breezhaler or continued their treatment. The Seebri Breezhaler treatment arms were underpowered because of size, according to Novartis.
Investigators found that patients who switched to Ultibro Breezhaler had improvements in lung function and breathlessness at week 12, which was a primary objective of the study. Other primary objectives of the study included superiority of the Seebri Breezhaler versus other previous treatments, in terms of lung function and breathlessness.
The study was designed to mimic clinical practice, so there was no washout period between treatments, Novartis reported. These findings suggest that Ultibro Breezhaler could potentially be an effective treatment for patients whose current COPD treatment is not controlling symptoms.
The data also supports the 2017 GOLD recommendation that it should become the standard first-line treatment for patients with symptomatic COPD, according to Novartis.
Currently, Ultibro Breezhaler, a long-acting beta-adrenoceptor antagonist monotherapy/long-acting muscarinic antagonist dual bronchodilator, is approved in the European Union as a maintenance treatment for COPD.
Data from previous clinical trials shows that Ultibro Breezhaler can significantly improve bronchodilation compared with standard treatments. It is also the only steroid-free treatment that offers superiority over the most prescribed treatment in preventing symptoms, according to the press release.
Ultibro Breezhaler has received approval in more than 90 countries, including those within the European Union, Latin America, Japan, Canada, Switzerland, and Australia.
"Today's results are significant as they show for the first time the positive effect of directly switching to Ultibro Breezhaler from other COPD treatments, such as inhaled steroid-containing combination therapies," said Vasant Narasimhan, global head Drug Development and chief medical officer for Novartis. "By showing that improved symptom control can be achieved through using Ultibro Breezhaler, the CRYSTAL study provides further support to limit the use of inhaled steroid-containing therapies to specific patient types that really need it."