Projekt
A multicenter, randomized, 52-week, double-blind, parallel group, active controlled study to compare the efficacy and safety of QVM149 with QMF149 in patients with asthma
Automatisch geschlossen · 2016 bis 2018
Baty Florent, Schlotter Sandra, Brutsche Martin
Art
Reichweite
Bereiche
Status
Start
Ende
Finanzierungsart
Kurzbeschreibung/Zielsetzung
Asthma is a serious global health problem affecting all age groups.
Despite existing therapies, there are significant unmet medical
needs in treating asthma. Novartis is developing QVM149, a fixed-dose combination (FDC) of indacaterol acetate, an inhaled Long-Acting Beta Agonist (LABA) with a 24-hour duration of action; glycopyrronium
bromide an inhaled Long-Acting Muscarinic Antagonist (LAMA) with 24 hours duration of action; and mometasone furoate (MF), an Inhaled corticosteroids (ICS) for once-daily maintenance treatment of asthma GINA 2015 step ≥4. QVM149 is delivered via Breezhaler®, a single dose dry powder inhaler (SDDPI) for maintenance treatment for severe asthma. In parallel, Novartis is also developing QMF149, which is an FDC of mometasone furoate (MF) and indacaterol, in the Concept 1 device. Long-term treatment with QMF149 once daily has been shown to have a
favourable safety/efficacy profile in adolescent and adult patients with persistent asthma (Beasley et al 2015).
Given that many asthma patients have poorly controlled disease despite currently available controller medications and there is increasing evidence of lung function benefit and improved control with triple combination therapy, further investigation of QVM149 triple therapy is supported. Earlier, a review evaluating the efficacy profile of a LAMA (tiotropium) as add-on therapy to ICS or LABA/ICS in patients with uncontrolled moderate to severe persistent asthma concluded that the addition of a LAMA resulted in significant improvements in lung function (FEV1 and peak expiratory flow) (Befekadu 2014). The purpose of the trial is to evaluate the efficacy and safety of two different doses of QVM149 (QVM149 150/50/80 μg and QVM149 150/50/160 μg via Breezhaler®) over two respective QMF149 doses (QMF149 150/160 μg and QMF149 150/320 μg via Breezhaler® in poorly controlled asthmatics as determined by pulmonary function testing and effects on asthma control.