The post hoc analysis from the pivotal Phase III IRIDIUM study—presented virtually at the European Respiratory Society (ERS) International Congress 2020— also showed the safety profile for high-dose Enerzair Breezhaler was in line with previous studies in the Phase III/IIIb PLATINUM clinical development program.
“This post hoc analysis supports the potential of high-dose IND/GLY/MF as an effective step-up treatment option to further reduce asthma exacerbations in patients with uncontrolled asthma,” said Kenneth Chapman, Professor of Medicine, University of Toronto. “These findings also complement the efficacy and safety data from the pivotal IRIDIUM study, which indicated the potential of high-dose IND/GLY/MF to improve lung function and reduce exacerbations compared with salmeterol xinafoate/fluticasone propionate (Sal/Flu), a LABA/ICS standard-of-care.”
The analysis showed high-dose Enerzair Breezhaler (150/50/160 μg) significantly reduced the annualized rate of moderate-or-severe asthma exacerbations by 21% (p=0.026) and severe exacerbations by 31% (p=0.003) in asthma patients not adequately controlled on current inhaled therapies, compared with medium-dose (150/50/80 μg) over 52 weeks.
High-dose Enerzair Breezhaler also reduced the annualized rate of all exacerbations (mild, moderate and severe) by 14% (p=0.132) compared with medium-dose, but this finding was not statistically significant. Both doses tested presented with a favorable safety and tolerability profile.
Source: Company Press Release