Novartis announced positive data from the CRYSTAL study evaluating the effects of directly switching symptomatic, non-frequently exacerbating patients with moderate chronic obstructive pulmonary disease (COPD) from their current treatments to Ultibro Breezhaler (indacaterol/glycopyrronium) 110mcg/50mcg.
The prospective, multicenter, 12-week, randomized, pragmatic, open-label study included 4,389 patients with moderate COPD who were switched to Ultibro Breezhaler from their prior therapy, including long-acting beta agonists (LABA) + inhaled corticosteroid (ICS) or LABA + long-acting muscarinic antagonist (LAMA); a washout period was not included as the study was designed to mimic clinical practice. They were randomized to a direct switch to Seebri Breezhaler (glycopyrronium) 50mcg or Ultibro Breezhaler 110mcg/50mcg once daily vs. continuation of previous treatment.
Primary objectives of the study included superiority of Ultibro Breezhaler vs. LABA, LAMA, and LABA + ICS in regards to lung function and breathlessness at Week 12; superiority of Seebri Breezhaler vs. previous short-acting beta agonist and/or short-acting muscarinic antagonist treatment in regards to lung function and breathlessness at Week 12; and non-inferiority of Seebri Breezhaler vs. previous LABA or LAMA in regards to lung function and breathlessness at Week 12.
After switching to Ultibro Breezhaler, study patients demonstrated superior improvements in lung function (trough FEV1) and breathlessness at Week 12 (P<0.0001). Ultibro Breezhaler was also well tolerated in the study.
Ultibro Breezhaler is a once-daily dual bronchodilator that combines indacaterol, a LABA, and glycopyrronium, a LAMA. Seebri Breezhaler contains glycopyrronium and is a once-daily LAMA bronchodilator.