Novartis (NVS) announced new data from the QUANTIFY study, which demonstrated the non-inferiority of Ultibro Breezhaler 110/50 mcg compared to tiotropium 18 mcg plus formoterol 12 mcg in terms of health-related quality of life outcomes in moderate-to-severe chronic obstructive pulmonary disease patients at week 26.
In the QUANTIFY study, which included over 900 COPD patients, once-daily Ultibro Breezhaler showed superior improvements in lung function (trough FEV1) at 26 weeks compared to once-daily tiotropium plus twice-daily formoterol in moderate-to-severe COPD patients. Additionally, patients taking Ultibro Breezhaler were more likely to demonstrate a clinically meaningful improvement in shortness of breath and health-related quality of life at 26 weeks compared to tiotropium plus formoterol, the company said. The safety and tolerability of Ultibro Breezhaler was comparable to the other treatment arm in the study.
"These positive results from QUANTIFY demonstrate that once-daily Ultibro Breezhaler can provide better symptom control versus a combination of two individual treatments, tiotropium plus formoterol. More patients on Ultibro Breezhaler had a meaningful improvement in health-related quality of life demonstrating superiority of our LABA/LAMA vs tiotropium plus formoterol," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals.
QUANTIFY was a 26-week treatment, multicenter, randomized, parallel group, blinded study to assess the efficacy and safety of once-daily Ultibro Breezhaler in 934 patients with moderate-to-severe COPD, versus the free-combination of tiotropium 18 mcg plus formoterol 12 mcg.
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