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Indacaterol/Glycopyrronium/Mometasone: A Review in Asthma

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Abstract

Indacaterol/glycopyrronium/mometasone (Enerzair® Breezhaler®) is a fixed-dose combination of the long-acting β2 agonist (LABA) indacaterol, the long-acting muscarinic antagonist (LAMA) glycopyrronium and the inhaled corticosteroid (ICS) mometasone furoate (hereafter referred to as mometasone) delivered via a capsule-based dry-powder inhaler. It is approved in the EU for use as maintenance treatment in adult patients with inadequately controlled asthma who had experienced one or more exacerbations in the previous year. The approval also includes an optional digital companion (sensor and app) that provides data on the patient’s use of the inhaler. In the 52-week IRIDIUM trial in patients with inadequately controlled asthma, indacaterol/glycopyrronium/mometasone improved lung function to a greater extent than LABA/ICS combinations (i.e. indacaterol/mometasone and fluticasone propionate/salmeterol), but superiority in Asthma Control Questionnaire 7 score was not shown. In the 24-week ARGON trial, indacaterol/glycopyrronium/mometasone via a single inhaler was non-inferior to fluticasone propionate/salmeterol + tiotropium via two inhalers with regard to Asthma Quality of Life Questionnaire score. Indacaterol/glycopyrronium/mometasone was generally well tolerated, and the most common adverse events were respiratory in nature. In conclusion, combination therapy with indacaterol/glycopyrronium/mometasone represents a valuable option for the maintenance treatment of asthma, with the convenience of once-daily administration via a single inhaler.

Plain language summary

Asthma is a chronic inflammatory lung disease characterized by repeated episodes of wheezing, breathlessness, coughing and chest tightness. Some patients with asthma have inadequately controlled disease despite treatment with an inhaled corticosteroid (ICS) and a long-acting β2 agonist (LABA). The addition of a long-acting muscarinic antagonist (LAMA) may provide further benefit, but has traditionally required the use of two separate inhalers. Indacaterol/glycopyrronium/mometasone (Enerzair® Breezhaler®) is the first fixed-dose LABA/LAMA/ICS combination for asthma therapy. It is administered once daily using a single inhaler. There is also an optional digital sensor that attaches to the base of the device to collect data on the use of the inhaler by the patient. Indacaterol/glycopyrronium/mometasone improved lung function to a greater extent than LABA/ICS combinations in adult patients with inadequately controlled asthma who had experienced one or more exacerbations in the previous year. Indacaterol/glycopyrronium/mometasone was generally well tolerated. The most common adverse events were respiratory-related. Combination therapy with indacaterol/glycopyrronium/mometasone is a valuable, convenient option for the maintenance treatment of asthma.

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Acknowledgements

During the peer review process, the manufacturer of indacaterol/glycopyrronium/mometasone (Novartis) was also offered an opportunity to review this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.

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Correspondence to Hannah A. Blair.

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The preparation of this review was not supported by any external funding.

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Hannah Blair is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

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Not applicable.

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The manuscript was reviewed by: M. Cazzola, Department of Experimental Medicine, University of Rome Tor Vergata, Rome, Italy; K. R. Chapman, Asthma & Airway Centre, University Health Network and Toronto Western Hospital, Toronto, ON, Canada.

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Blair, H.A. Indacaterol/Glycopyrronium/Mometasone: A Review in Asthma. Drugs 81, 709–719 (2021). https://doi.org/10.1007/s40265-021-01518-w

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