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

Kenneth Chapman; Richard van Zyl-Smit; Jorge Maspero; Huib A M Kerstjens; Yasuhiro Gon; Motoi Hosoe; Ana-Maria Tanase; Abhijit Pethe; Xu Shu; Peter D'Andrea

doi:10.1136/bmjresp-2020-000819

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

BMJ Open Respir Res. 2021 Aug;8(1):e000819. doi: 10.1136/bmjresp-2020-000819.

Authors

Affiliations

¹ Division of Respiratory Medicine, Department of Medicine, University of Toronto, Toronto, Ontario, Canada ken.chapman.airways@gmail.com.
² Division of Pulmonology and UCT Lung Institute, Department of Medicine, University of Cape Town, Cape Town, South Africa.
³ Allergy and Respiratory Research Unit, Fundación Centro Investigacion de Enfermedades Alergicas y Respiratorias, Buenos Aires, Argentina.
⁴ Department of Pulmonology, University of Groningen, University Medical Center Groningen, and Groningen Research Institute for Asthma and COPD, Groningen, The Netherlands.
⁵ Division of Respiratory Medicine, Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan.
⁶ Novartis Pharma AG, Basel, Switzerland.
⁷ Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.

Abstract

Background: Despite 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.

Methods: This 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.

Results: In 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.

Conclusions: One 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.

Keywords: asthma; asthma in primary care; asthma pharmacology.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Asthma* / drug therapy
Drug Combinations
Fluticasone-Salmeterol Drug Combination
Humans
Indans
Mometasone Furoate
Quinolones

Substances

Drug Combinations
Fluticasone-Salmeterol Drug Combination
Indans
Quinolones
Mometasone Furoate
indacaterol

Associated data

ClinicalTrials.gov/NCT02571777
ClinicalTrials.gov/NCT02554786