Novart's high dose of Enerzair Breezhaler significantly reduced the rate of acute asthma attacks in moderate to severe.

Recently, Novartis announced that in patients with asthma who have uncontrollable asthma with medium or high doses of long-acting beta-2 subjectors (LABA)/inhaled corticosteroids (ICS), a large daily dose of Enerzair Breezhaler combination (acetic aciddattro/Glon bromide/mormisone, IND/GLY/MF) can significantly reduce the acute rate of asthma attacks compared to one daily moderate or severe asthma attack.
IRIDIUM is a Phase III, Multi-Center, Randomized, Double-Blind, Parallel Study designed to compare the efficacy and safety of IND/GLY/MF with IND/MF in asthma patients.
the purpose of this study was to assess the efficacy of two different doses of IND/GLY/MF (high 150/50/160 μg, medium 150/50/80μg) relative to two corresponding IND/MF doses (high 150/320?g, medium 150/160μg) in patients with uncontrolled asthma.
patients who participated in the trial had symptoms at the time of screening, and in the past year some 3,092 asthma patients participated in the trial, who were evenly distributed and randomly grouped (approximately 618 patients per treatment group) to receive the following treatment groups: IND/GLY/MF 150/50/80μg (once a day), IND/G LY/MF 150/50/160μg (once daily), IND/MF 150/160μg (once daily), IND/MF 150/320μg (once daily), Sal/Flu 50/500μg (twice daily).
the main purpose of this study was to demonstrate the efficacy of high-dose IND/GLY/MF relative to high-dose IND/MF, medium-dose IND/GLY/MF to moderate-dose IND/MF treatment of asthma patients after 26 weeks of treatment.
secondary endpoint of the trial was to demonstrate the advantages of two doses of IND/GLY/MF and two doses of IND/MF in improving asthma control questionnaire scores after 26 weeks of treatment in asthma patients.
other secondary endpoints include high-dose IND/GLY/MF compared to high-dose IND/MF and medium-dose IND/GLY/MF to medium-dose IND/MF, resulting in a reduction in patient deterioration rates, and secondary analysis includes a two-dose comparison of the effectiveness of IND/GLY/MF with Sal/Flu (50/500μg).
analysis showed that high-dose triple therapy reduced the annualized rate of acute asthma attacks by 21% (p -0.026) compared to moderate doses (150/50/80μg) over 52 weeks, and that the therapy could also reduce the annualized rate of severe acute asthma that is not adequately controlled by current inhalation therapy by 31% (p-0.003).
Compared to medium doses, high-dose triple therapy also reduced the annualization rate of all disease exacerbations (mild, moderate and severe) by 14% (p s 0.132), but this finding was not statistically significant.
patients with both test doses showed good safety and tolerance.
analysis of the key Phase III IRIDIUM study showed that patient safety in high-dose triple therapy was consistent with previous findings in the III/IIIb PLATINUM clinical development program.
analysis supports the potential of high doses of IND/GLY/MF as an effective stage treatment option that can further reduce asthma attacks in uncontrolled asthma patients.
study also supplemented the efficacy and safety data from a key IRIDIUM study that showed that high-dose triple therapy had the potential to improve lung function and reduce exacerbation compared to Sal/Flu.
Novarma Enerzair Breezhaler triple therapy is a fixed-dose combination of acetic aciddatero (a type of LABA), GLY, long-acting toxaline inhibitor antagonist LAMA, and momisson (MF, high-dose ICS).
enerzair Breezhaler was given the drug using a Breezhaler device with a dose confirmation mechanism, which allows daily inhalation treatment using a single inhaler.
, the treatment was approved by the European Union.
reference source: Novartis post hoc analysiss show high-dose Enerzair Breezhaler reduces asthma medium-dose, matching key pivotal IRIDIUM study.