Novarma Asthma Compound Inhaler Phase 2 clinical results were positive

May 22, Novartis published data from its Phase 2 clinical study on the treatment of asthma patients with compound therapy IND/GLY/MF (QVM149), both of which showed that QVM149 treatment was better than that of the control group shametero/fluorotikasong (standard therapy) and placebo, significantly improving lung function in asthma patients.
QVM149 is a fixed-dose compounding agent consisting of a double bronchial dilant (long-acting β-acting β-acting datero and long-acting toxaline-alkali-insanity antagonist Glon bromide) and a medium- and high-dose glucocorticoid momishone, delivered by the inhaler Breezhaler.in the CQVM149B2208 study, two doses of QVM149 (150/50/160 Mug, high dose ICS; Compared with high-dose ICS), FEV1 peaks (force exhalation within 1 second) improved significantly, with average deviations of 172 ml (95% CI: 137,208) and 159 ml (95% CI:123,195), respectively, (p<0.001), and the study reached the main endpoint.
addition, the high and medium dose QVM149 also reached a secondary end point, FEV1AUC (FEV1AUC) compared to the twice-daily 50/500 Mug shametero/fluorotikasson. FEV1 curve area) has significantly improved during the time interval between FEV1AUC5min-1h and FEV1AUC5min-23h45min (p<0.001).
Henrik Watz, of the German Lung Research Centre, said: "These results suggest that this new combination of double bronchial dilation and inhalation of glucoticoids could provide more lung function to asthma patients on top of established therapies. "
in the study CQVM149B2209, a daily QVM149 showed consistent and substantial improvements in lung function during 24-hour drug use in adult asthma patients. The study also reached its main endpoint, with a significant improvement over FEV1 over 14 days, regardless of whether QVM149 was used, either morning or night, with an average difference of 610 ml (90% CI:538,681) and 615 ml (90% CI:544,687).
safety data from two studies show that QVM149 has good safety and tolerance. The adverse events observed in the QVM149 group were comparable to between placebo (CQVM149B2209) and shametero/fluoroticasson (CQVM149B2208), both of which did not report serious adverse events during treatment.
, Phase 3 clinical trials are currently under way, Novaral will provide more data and analysis at future medical conferences and explore clinical and regulatory avenues for QVM149. "Despite a lot of treatment, more than a third of people with asthma are out of control," says Linda Armstrong, Novart's head of respiratory development. The results of these Phase 2 studies show progress in the treatment of this combination, if approved, or may improve the lives of asthma patients with symptoms that are not yet under control. (Sina Pharmaceutical Compilation/David)