Novartis AG said inhaled combination therapy QMF149 met the main goal of improving lung function in certain asthma patients in a late-stage study.
The drug, an inhaled, fixed-dose combination therapy of indacaterol acetate and mometasone furoate, was evaluated in an 802-patient phase 3 study, called Quartz.
QMF149 was compared with mometasone furoate, or MF, alone delivered via the Twisthaler device in adult and adolescent patients with inadequately controlled asthma who either had or did not have additional maintenance treatment.
In first study results, the combination therapy showed statistically significant improvements in lung function in the patients compared with MF alone, as measured by trough FEV1, or the volume of air that can be forced out in one second after taking a deep breath, measured about a day after the last administration of the therapy.
It also demonstrated statistically significant improvements in asthma control compared with standalone MF therapy, as measured by the Asthma Control Questionnaire 7 after 12 weeks of treatment.
Both the combination and MF alone were well-tolerated, with side effects appearing less frequently in patients taking QMF149.
Asthma affects about 358 million people globally, and the condition remains uncontrolled in more than a third of patients despite a number of treatments. The Swiss drugmaker said fixed-dose combination inhalers may help asthmatics by simplifying complex inhaler regimens.
The Quartz study is part of Novartis' phase 3 clinical development program called Platinum.