Effect of indacaterol/mometasone on lung function in adolescents versus overall patient population: PALLADIUM study

05 Aug 2021
Respiratory topics
  • Treatment - drug
Type of resource
Dublin 2021
Matthias Krull, Institut fur Allergie- und Asthmaforschung Berlin, IAAB, Germany
Clinical Research Results Aim: This analysis from the PALLADIUM study (NCT02554786) evaluated the effect of indacaterol acetate/mometasone furoate (IND/MF) medium- and high-dose on lung function in adolescent (12 – 17 years) patients and overall population with inadequately controlled asthma.Methods: This 52 week, double-blind, parallel-group study included 2216 patients (≥12–≤75 years), of which 107 were adolescents, having a pre-bronchodilator forced expiratory volume in one second (FEV1) ≥50%–<85% and asthma control questionnaire (ACQ)-7 ≥1.5 at screening. The effect of IND/MF medium- (150/160 μg) and high-dose (150/320 μg) once-daily (o.d.) via Breezhaler® versus respective MF doses (400 μg o.d. and 400 μg twice daily [b.i.d.]) via Twisthaler® and IND/MF high-dose via Breezhaler® versus salmeterol xinafoate/fluticasone propionate (SAL/FLU) high-dose (50/500 μg b.i.d) via Diskus® on trough FEV1, peak expiratory flow (PEF) and post-dose FEV1 was assessed.Results: In adolescents, IND/MF improved trough FEV1 (at Week 26) and PEF (over 52-weeks) to a greater extent versus MF, with a rapid onset of action (post-dose FEV1); the data was in line with the overall population (Table). IND/MF high-dose showed comparable results in trough FEV1 and PEF vs SAL/FLU high-dose in adolescents, whereas in the overall population, greater improvements in PEF were observed with IND/MF.Conclusions: A greater improvement in lung function and a rapid onset of action with IND/MF high- and medium-dose o.d. versus respective MF doses was observed in adolescents, and are consistent with the overall patient population. Implementation Science/Service Development Research Ideas on Respiratory Conditions and Tobacco Dependency Abstract Declaration of Interest Matthias Krüll reports receiving advisory board and honoraria for academic talks from ALK, AstraZeneca, Berlin-Chemie, Chiesi, Novartis, and Sanofi-Aventis, outside of the submitted work. Richard van Zyl-Smit reports advisory board and honoraria for academic talks from Aspen/GSK, Pfizer, Roche, AstraZeneca, Novartis, MSD, and Cipla, outside of the submitted work. Christian Gessner reports receiving personal fees for advisory board and honoraria for academic talks from GSK, Pfizer, AstraZeneca, Roche, Novartis, BMS, MSD, Berlin-Chemie, Chiesi, Boehringer Ingelheim, and Sanofi, outside of the submitted work. Yasuhiro Gon reports receiving personal fees from Novartis, GlaxoSmithKline, AstraZeneca, and Boehringer Ingelheim, outside the submitted work. Oliver Noga reports receiving personal fees as a member of the Novartis Advisory Board and for sponsored lectures, outside of the submitted work. Alexia Richard and Ana-Maria Tanase are employees of Novartis Pharma, Basel, Switzerland. Amy de los Reyes, Xu Shu, Abhijit Pethe, and Peter D’Andrea are the employees of Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. The study (clinicaltrial.gov.in: NCT02554786) was funded by Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA. References and Clinical Trial Registry Information