Novartis said Tuesday that it has presented the results of BEYOND, a clinical trial for comparing the therapeutic efficacy and safety of its Xoterna Breezehaler and tiotropium in patients with mild to moderate chronic obstructive pulmonary disease (COPD).
In the BEYOND study, the company divided patients with mild to moderate COPD over 40 years of age who had received tiotropium into two groups - 110/50μg dosage of Xoterna daily, and the 18μg dosage of tiotropium daily.
In the case of Xoterna treated group, the company replaced Xoterna without withdrawal period to mimic a similar environment of an actual clinical situation. During the 12 week trial, the company compared forced expiratory volume (FEV1) in one second, transition dyspnea indexes (TDI), COPD assessment test (CAT) and severe adverse reactions.
As a result, the Xoterna treated group improved lung function (FEV1) by 50 mL at week 12 compared to tiotropium. Also, the lung function improvement rate of FEV1 100ml or more was 42.2 percent, 2.38 times higher than the tiotropium group’s 26.4 percent.
Although the TDI was 0.31 higher than the control group while CAT scores 0.81 lower, the result did not present any statistically significant differences. Also, Xoterna showed a safety profile similar to that of tiotropium in adverse events.
At week 12, the rate of adverse events in the Xoterna treated group was 30.2 percent, similar to the tiotropium treated group (25.5 percent). Serious adverse events were also similar in the Xoterna-treated group (4.2%) and tiotropium group (1.6 percent).
“The clinically significant minimum improvement in lung function starts from FEV1 100ml,” said Professor Yoo Kwang-wha of the department of allergy and clinical immunology department at Konkuk University Medical Center. “Considering that the study has confirmed improvement effect of Xoterna over 100ml of FEV1, it is meaningful to have provided a basis for the improvement of lung function in the domestic mild-moderate COPD patients when they replace their treatment from Xoterna to tiotropium.”
This BEYOND study reaffirmed the results of the previous SHINE study, which identified excellent therapeutic efficacy and a similar safety profile when comparing Xoterna to tiotropium in the treatment of COPD, he added.