Novartis Phase IIIb ARGON study meets primary endpoint in a comparison of Enerzair Breezhaler (QVM149) versus a free combination of two existing inhaled treatments in uncontrolled asthma - Seite 2

The primary endpoint of the study was met, with both high- and medium- doses of IND/GLY/MF demonstrating non-inferiority in change from baseline in Asthma Quality of Life Questionnaire (AQLQ) score (high: 0.073; medium: −0.038; both p<0.001)¹.

“Novartis is reimagining respiratory medicine by developing innovative, patient-focused medicines such as IND/GLY/MF that address areas of significant unmet clinical need and improve symptom control and quality of life for people with asthma,” said Dominic Brittain, Respiratory Global Program Head, Novartis Pharmaceuticals. “The ARGON study results show the potential benefits of this once-daily, single inhaler, LABA/LAMA/ICS treatment option in patients with uncontrolled asthma. These data build on the clinically meaningful improvements in lung function and reduction of exacerbations observed for high-dose IND/GLY/MF in the IRIDIUM study.”

In secondary analyses, improvements in asthma control (as measured by Asthma Control Questionnaire; ACQ-7 score [−0.124; p=0.004]) and lung function (as measured by trough FEV₁ [96 mL; p<0.001]) were seen with high-dose IND/GLY/MF compared with high-dose Sal/Flu plus Tio¹. In additional exploratory analyses, improvements in health status (as measured by St. George’s Respiratory Questionnaire; SGRQ [−2.00; p=0.04]), and peak expiratory flow (morning [9.56 L/min; p=0.005], evening [9.15 L/min; p=0.006]) were seen with high-dose IND/GLY/MF compared with high-dose Sal/Flu plus Tio¹. A greater reduction in the rate of moderate exacerbations (43%; p=0.04) was seen with high-dose IND/GLY/MF versus high-dose Sal/Flu plus Tio; the rate of exacerbations across all severities was comparable between the two treatment groups¹. Comparable efficacy in these endpoints was seen with medium-dose IND/GLY/MF versus high-dose Sal/Flu plus Tio, but at a corresponding lower steroid dose¹. Adverse events were generally comparable across treatments¹.

The ARGON study assessed IND/GLY/MF, a once-daily, fixed-dose combination of a long-acting beta₂-agonist (LABA), a long-acting muscarinic antagonist (LAMA) and an inhaled corticosteroid (ICS) in high- (150/50/160 µg) and medium- (150/50/80 µg) doses, delivered via the Breezhaler, compared with a free combination of twice-daily high-dose Sal/Flu (50/500μg) plus once-daily Tio (5 μg) in patients with asthma not adequately controlled on current inhaled therapies, over 24 weeks of active treatment¹.