Novartis has announced that a phase III QUARTZ study of its investigational inhaled combination treatment, QMF149, has met primary and key secondary endpoints in patients with inadequately controlled asthma. The once-daily, fixed-dose treatment demonstrated significant improvements in lung function and asthma control versus inhaled corticosteroid (ICS) alone.
The first study results show that the indacaterol acetate and mometasone furoate combination demonstrated statistically significant improvements in lung function as measured through ‘FEV’, which is the volume of air that can be forced out in one second after taking a deep breath - measured approximately 24 hours after the last administration of study drug.
The study enrolled 802 male and female patients with a mean age of 45.6 years and a mean duration of asthma of 14 years.
Novartis is “very pleased with the results of the QUARTZ study looking at the efficacy and safety of the fixed dose combination of indacaterol and mometasone furoate," commented Dr Oliver Kornmann, Pulmonary Department, Internal Medicine, University Hospital Mainz, Germany.
He continued, ”Fixed-dose combination inhalers may offer advantages to people with asthma by simplifying complex inhaler regimens, especially when they can be dosed once daily which can therefore further reduce the burden of the disease.”
Asthma affects an estimated 358 million people worldwide and can cause a significant personal, health, and financial burden when not adequately controlled, but despite the availability of numerous asthma treatments, more than one-third of patients remain uncontrolled.
"Despite the number of available treatments, many patients' lives remain impacted by their asthma," said Linda Armstrong, respiratory development unit head.
She continued, ”The QMF149 results of the QUARTZ study complement the recently presented phase II data of QVM149 at the 2019 American Thoracic Society Congress, showing superiority of QVM149 to the current standard of care. We look forward to seeing the rest of the data from the PLATINUM clinical trial program.”
The combo is currently in development for the treatment of inadequately controlled asthma in patients who remain symptomatic despite current treatment.