Indacaterolacetat / Glycopyrroniumbromid / Mometasonfuroat (1) – Enerzair Breezhaler®

• Clinical trials
  • In the ARGON trial, the combination of active substances Ind/Glyc/Mom in two different dosages (150/50/80 µg or 150/50/160 µg) was compared with salmeterol/fluticasone (Sal/Flu) + tiotropium (Tio).

Adult patients with asthma who are not adequately controlled on a combination of a LABA and a high dose of an inhaled corticosteroid as maintenance therapy and who have experienced one or more asthma exacerbations in the previous year

• For adult patients with asthma who are not adequately controlled on a combination of a LABA and a high dose of an inhaled corticosteroid as maintenance therapy and who have experienced one or more asthma exacerbations in the previous year, additional benefit is not proven.
• mortality
  • No statistically significant difference was observed between the treatment groups for the endpoint of all-cause mortality.
• Morbidity – Severe asthma exacerbations
  • In the ARGON study, a severe asthma exacerbation was defined as an asthma exacerbation requiring medical treatment by a doctor, admission to an A&E department (or equivalent facility), or hospitalisation and treatment with OCS for at least 3 days.
  • For the endpoint of severe asthma exacerbations, neither analysis showed a statistically significant difference between the treatment groups.
• Morbidity – Asthma symptoms
  • With regard to asthma symptoms, assessed using the ACQ-5, the results show no statistically significant difference between the treatment groups.
• Health-related quality of life
  • In summary, for the endpoint of health-related quality of life, as measured by the mean change from baseline for both the AQLQ-S and SGRQ, there was no statistically significant difference between the treatment groups.
• Side effects
  • No statistically significant difference was observed between the treatment groups for either the SUEs endpoint or the endpoint of discontinuation due to adverse events.
• Overall assessment / Conclusion
  • For the benefit assessment of the combination of indacaterol acetate, glycopyrronium bromide and mometasone furoate for the treatment of adult patients with asthma who are not adequately controlled with a combination of a LABA and a high-dose inhaled corticosteroid as maintenance therapy and who have experienced one or more asthma exacerbations in the previous year, results are available from the randomised, controlled Phase III ARGON trial on mortality, morbidity, health-related quality of life and side effects, compared with treatment with salmeterol/fluticasone and tiotropium.
  • No significant differences were observed between the treatment groups in any endpoint category.
  • There is no additional benefit for the combination of indacaterol acetate, glycopyrronium bromide and mometasone furoate in adult patients with asthma, who are not adequately controlled with a combination of a LABA and a high dose of an inhaled corticosteroid as maintenance therapy and who have experienced one or more asthma exacerbations in the previous year, has not been demonstrated compared with the appropriate comparator therapy of salmeterol/ There is no proof that fluticasone and tiotropium are effective.

Courtesy translation only, please refer to the German original.