One time a day mometasone/indacaterol fixed-dose combination versus two times a day fluticasone/salmeterol in patients with inadequately controlled asthma: pooled analysis from PALLADIUM and IRIDIUM studies

• Published in: BMJ open respiratory research Vol. 8; no. 1; p. e000819
• Main Authors: Chapman, Kenneth, van Zyl-Smit, Richard, Maspero, Jorge, Kerstjens, Huib A M, Gon, Yasuhiro, Hosoe, Motoi, Tanase, Ana-Maria, Pethe, Abhijit, Shu, Xu, D’Andrea, Peter
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01-08-2021; BMJ Publishing Group
• Subjects: Asthma; Asthma - drug therapy; Drug Combinations; Fluticasone-Salmeterol Drug Combination; Glucocorticoids; Humans; Indans; Inhalers; Mometasone Furoate; Palladium; Patients; Quinolones; Steroids; asthma pharmacology; asthma; asthma in primary care
• ISSN: 2052-4439; 2052-4439
• DOI: 10.1136/bmjresp-2020-000819

BackgroundDespite currently available standard-of-care inhaled corticosteroid (ICS)/long-acting β2-agonist therapies, a substantial proportion of patients with asthma remain inadequately controlled. This pooled analysis evaluated efficacy and safety of mometasone furoate/indacaterol acetate (MF/IND) versus fluticasone propionate/salmeterol xinafoate (FLU/SAL) in patients with inadequately controlled asthma.MethodsThis analysis included patients from PALLADIUM (NCT02554786) and IRIDIUM (NCT02571777) studies who received high-dose MF/IND (320/150 µg) or medium-dose MF/IND (160/150 µg) one time a day or high-dose FLU/SAL (500/50 µg) two times a day for 52 weeks. Reduction in asthma exacerbations, improvement in lung function, asthma control, and safety were evaluated for 52 weeks.ResultsIn total, 3154 patients (high-dose MF/IND, n=1054; medium-dose MF/IND, n=1044; high-dose FLU/SAL, n=1056) were included. High-dose MF/IND showed 26%, 22% and 19% reductions in rate of severe, moderate or severe, and all (mild, moderate and severe) exacerbations versus high-dose FLU/SAL, respectively, over 52 weeks (all, p<0.05). High-dose MF/IND improved trough FEV1 versus high-dose FLU/SAL at weeks 26 (Δ, 43 mL, p=0.001) and 52 (Δ, 51 mL, p<0.001). Reductions in asthma exacerbation rate and improvement in trough FEV1 with medium-dose MF/IND were comparable with high-dose FLU/SAL over 52 weeks. All treatments improved Asthma Control Questionnaire-7 score from baseline to 52 weeks with no difference between treatments. Safety was comparable between high-dose MF/IND and high-dose FLU/SAL.ConclusionsOne time a day, single-inhaler, high-dose MF/IND reduced asthma exacerbations and improved lung function versus two times a day, high-dose FLU/SAL in patients with inadequately controlled asthma. Similarly, improved outcomes were seen with one time a day, medium-dose MF/IND and two times a day, high-dose FLU/SAL, but at a lower ICS dose.