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

Abstract

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.

Mometasone/Indacaterol/Glycopyrronium (MF/IND/GLY) and MF/IND at Different MF Strengths versus Fluticasone Propionate/Salmeterol Xinafoate (FLU/SAL) and FLU/SAL+ Tiotropium in Patients with Asthma

“…All treatment arms showed improvement of asthma control in ACQ-7 score from baseline (≥0.5-point reduction from baseline, MCID) at respective study time points. 17,21,27 Medium-dose MF/IND showed comparable, and high-dose MF/ IND showed a greater reduction in ACQ-7 score versus high-dose FLU/SAL at Week 26 (Table 5). These ACQ-7 score improvements were comparable between treatments at Week 52.…”

“…21 The results from individual studies are published elsewhere. 17,21,23,27 A brief description of all Phase III studies including PALLADIUM, IRIDIUM, and ARGON is provided in Table 1. Details of the individual study descriptions, methods, and patient inclusion criteria are published.…”

“…(i) Medium-and high-dose MF/IND versus high-dose FLU/SAL (pooled data from PALLADIUM 23 and IRIDIUM 17 studies). 27 (ii) Medium-and high-dose MF/IND/GLY versus high-dose FLU/SAL (data from the IRIDIUM study). 17 (iii) Medium-and high-dose MF/IND/GLY versus high-dose FLU/SAL + TIO (data from the ARGON study).…”

“…A detailed description of baseline demographics and clinical characteristics is provided in the respective manuscripts. 17,21,23,27 Trough FEV 1…”

“…The detailed safety results for MF/IND and MF/IND/GLY versus FLU/SAL and FLU/SAL + TIO are available in the published papers of the individual studies. 17,21,23,27 added. Our study design did not allow us to determine with certainty which elements of the once-daily formulations produce these differences.…”