Mometasone/indacaterol demonstrates similar efficacy in men and women: Pooled analyses of PALLADIUM and IRIDIUM studies

Clinical Research Results Abstract IntroductionOnce-daily (o.d.), inhaled fixed-dose combination of mometasone furoate (MF) and indacaterol acetate (IND) via Breezhaler® is approved as maintenance treatment for asthma. Differences in asthma severity and treatment effects between genders have been reported. A pooled analysis from PALLADIUM (NCT02554786) and IRIDIUM (NCT02571777) evaluated the effect of gender on the efficacy and safety of high-dose MF/IND (320/150 μg) o.d. versus high-dose fluticasone/salmeterol (FLU/SAL; 500/50 μg) twice daily (b.i.d.) via Diskus® in patients with inadequately controlled asthma. MethodsPatients: PALLADIUM: 12–75 years, IRIDIUM: 18–75 years; pre-bronchodilator forced expiratory volume in 1 second (FEV1) % predicted: PALLADIUM: ≥50%–<85%, IRIDIUM: <80%; Asthma control questionnaire-7 (ACQ-7) score: ≥1.5 for both PALLADIUM and IRIDIUM. Outcomes: trough FEV1, ACQ-7 score, rescue medication use (Week 26); asthma exacerbations and safety (Week 52) stratified by gender (men,1237; women, 1946) from randomised population. Interaction P-values denote effect of gender on treatment. ResultsMen and women demonstrated comparable improvements in trough FEV1 and ACQ-7 score with high-dose MF/IND o.d. versus high-dose FLU/SAL b.i.d. (Table). As for rescue medication use and safety, treatment effects were consistent across genders for high-dose MF/IND vs high-dose FLU/SAL.ConclusionsHigh-dose MF/IND o.d. showed comparable improvements in lung function versus high-dose FLU/SAL b.i.d. in patients with inadequately controlled asthma, independent of gender. Research Idea Abstract Service Development & Evaluation Abstract Declaration of Interest 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.Karen Mezzi is an employee of Novartis Pharma.Funding: IRIDIUM and PALLADIUM studies were funded by Novartis Pharmaceuticals. Trial registration: IRIDIUM study is registered with ClinicalTrials.gov, NCT02571777. PALLADIUM study is registered with ClinicalTrials.gov, NCT02554786. References and Clinical Trial Registry Information