Efficacy of once-daily, single-inhaler, fixed-dose combination of mometasone/indacaterol/glycopyrronium in patients with asthma with or without persistent airflow limitation: Post hoc analysis from the IRIDIUM study

Richard N Van Zyl-Smit; Huib Am Kerstjens; Jorge F Maspero; Konstantinos Kostikas; Motoi Hosoe; Ana-Maria Tanase; Peter D'Andrea; Karen Mezzi; Dominic Brittain; David Lawrence; Kenneth R Chapman

doi:10.1016/j.rmed.2023.107172

Efficacy of once-daily, single-inhaler, fixed-dose combination of mometasone/indacaterol/glycopyrronium in patients with asthma with or without persistent airflow limitation: Post hoc analysis from the IRIDIUM study

Respir Med. 2023 May:211:107172. doi: 10.1016/j.rmed.2023.107172. Epub 2023 Mar 9.

Authors

Affiliations

¹ Division of Pulmonology and UCT Lung Institute, Department of Medicine, University of Cape Town, Cape Town, South Africa. Electronic address: richard.vanzyl-smit@uct.ac.za.
² Department of Pulmonology, University of Groningen, University Medical Center Groningen, Groningen Research Institute for Asthma and COPD, Groningen, the Netherlands.
³ Allergy and Respiratory Research Unit, Fundación Centro Investigacion de Enfermedades Alergicas y Respiratorias, Buenos Aires, Argentina.
⁴ Respiratory Medicine Department, University of Ioannina, Ioannina, Greece.
⁵ Novartis Pharma AG, Basel, Switzerland.
⁶ Novartis Pharmaceuticals Corporation, East Hanover, USA.
⁷ Division of Respiratory Medicine, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.

PMID: 36906187
DOI: 10.1016/j.rmed.2023.107172

Abstract

Background: A novel, once-daily, fixed-dose combination of mometasone furoate/indacaterol acetate/glycopyrronium bromide (MF/IND/GLY) delivered via Breezhaler® is the first inhaled corticosteroid/long-acting ꞵ₂-agonist/long-acting muscarinic antagonist (ICS/LABA/LAMA) therapy approved for the maintenance treatment of asthma in adults inadequately controlled on ICS/LABA combination. In patients with asthma and persistent airflow limitation (PAL), maximal treatment, especially with combination is suggested. This post hoc analysis of data from the IRIDIUM study assessed the efficacy of MF/IND/GLY in asthma patients with and without PAL.

Methods: Patients with post-bronchodilator FEV₁ ≤80% of predicted and FEV₁/FVC ratio of ≤0.7 were categorised as PAL subgroup and the remaining as the non-PAL subgroup. Lung function parameters (FEV₁, PEF, and FEF_25%-75%) and annualised asthma exacerbations rates were evaluated in both subgroups across the treatment arms: once-daily high-dose MF/IND/GLY (160/150/50 μg), high-dose MF/IND (320/150 μg) and twice-daily high-dose fluticasone/salmeterol (FLU/SAL; 500/50 μg).

Results: Of the 3092 randomised patients, 64% (n = 1981) met the criteria for PAL. Overall, there was no evidence of treatment difference between PAL and non-PAL subgroups (interaction P-value for FEV₁, FEF_25%-75%, PEF, moderate or severe exacerbations, severe exacerbations and all exacerbations were 0.42, 0.08, 0.43 0.29, 0.35 and 0.12, respectively). In the PAL subgroup, high-dose MF/IND/GLY versus high-dose MF/IND and high-dose FLU/SAL improved trough FEV₁ (mean difference: 102 mL [P < 0.0001] and 137 mL [P < 0.0001]) and reduced moderate or severe (16% and 32%), severe (25% and 39%) and all exacerbations (19% and 38%), respectively.

Conclusions: Once-daily fixed-dose MF/IND/GLY was efficacious in asthma patients with and without persistent airflow limitation.

Keywords: Asthma; Efficacy; Exacerbations; Long-acting muscarinic antagonist; Lung function; Persistent airflow limitation.

Publication types

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

MeSH terms

Administration, Inhalation
Adult
Asthma* / drug therapy
Bronchodilator Agents / therapeutic use
Drug Combinations
Forced Expiratory Volume
Glycopyrrolate
Humans
Indans
Iridium / therapeutic use
Lung
Mometasone Furoate
Nebulizers and Vaporizers
Pulmonary Disease, Chronic Obstructive* / drug therapy

Substances

Glycopyrrolate
Mometasone Furoate
indacaterol
Iridium
Drug Combinations
Indans
Bronchodilator Agents