QVM149, a potential new inhaled combination treatment, demonstrates improvements in lung function in patients with asthma irrespective of time of dosing
By Novartis | May 22, 2019
17 – 22 May 2019
American Thoracic Society
Novartis presented new clinical data from its Phase II study with QVM149, a potential new inhaled combination treatment for asthma, assessing the bronchodilator effects of once daily QVM149 following morning or evening dosing for 14 Days compared to placebo 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.
In study CQVM149B2209 (ClinicalTrials.gov Identifier: NCT03108027), once-daily IND/GLY/MF provided consistent and substantial lung function benefits over the entire 24-hour dosing interval in adult patients with asthma, irrespective of dosing time (morning or evening).
The study met the primary objective by demonstrating that once-daily inhaled QVM149 provides consistent and substantial lung function benefits over an entire 24-hour dosing interval, irrespective of whether patients receive QVM149 in the morning or evening. QVM149 improved FEV1AUC0-24h for both morning and evening administrations of IND/GLY/MF versus placebo over 14 days, with mean differences of 610 mL (90% CI: 538, 681) and 615 mL (90% CI: 544, 687) respectively.
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.