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QVM149, a potential new inhaled combination treatment, is superior to high-dose salmeterol/fluticasone propionate in improving lung function in patients with asthma (ATS 2019)

By Novartis | May 22, 2019

Conference

ATS 2019
17 – 22 May 2019
Dallas, U.S.
American Thoracic Society
Conference website


Summary

Novartis presented new clinical data from its Phase II study with QVM149, a potential new inhaled combination treatment for asthma, assessing the bronchodilator effect and safety of two doses of QVM149 compared to a fixed dose combination of salmeterol/fluticasone in adult patients with asthma.

QVM149 is an investigational, once-daily, fixed dose combination asthma treatment containing indacaterol acetate, glycopyrronium bromide and mometasone furoate (IND/GLY/MF), delivered with the dose-confirming Breezhaler® inhalation device.


Key findings

In the Phase II CQVM149B2208 study (ClinicalTrials.gov Identifier: NCT03063086), both once-daily doses of IND/GLY/MF (150/50/160 μg, high-dose ICS; 150/50/80 μg, medium-dose ICS) met the primary endpoint with statistically significant improvements in peak FEV1 (forced expiratory volume in the 1st second) versus twice daily salmeterol/fluticasone propionate (50/500 μg, high-dose ICS) with mean differences of 172 mL (95% CI: 137, 208) and 159 mL (95% CI: 123, 195), respectively (p<0.001).

Additionally, compared with salmeterol/fluticasone propionate, 50/500 μg twice a day, both high and medium doses of IND/GLY/MF met the secondary endpoint with statistically significant improvements (p<0.001) in FEV1AUC (FEV1 area under the curve) across both time intervals of FEV1AUC5min–1h and FEV1AUC5min–23h45min.

The safety data from this study also suggest that IND/GLY/MF has a favorable safety and tolerability profile.

QVM149 is currently being investigated in a Phase III clinical program, expected to complete in Q3 2019.

 

* Breezhaler® is a registered trademark of Novartis AG.


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