Triple Therapy with Mometasone/Indacaterol/Glycopyrronium or Doubling the ICS/LABA Dose in GINA Step 4: IRIDIUM Analyses.

IF 2.3 Q2 RESPIRATORY SYSTEM

Pulmonary Therapy Pub Date : 2023-09-01 Epub Date: 2023-08-01 DOI:10.1007/s41030-023-00234-y

Richard N van Zyl-Smit, Huib A M Kerstjens, Jorge Maspero, Ana-Maria Tanase, David Lawrence, Karen Mezzi, Peter D'Andrea, Kenneth R Chapman

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Abstract

Introduction: GINA guidelines recommend increasing the dose of inhaled corticosteroids (ICS) as a step-up option for patients with inadequately controlled asthma at GINA step 4 [inadequately controlled asthma on medium-dose ICS/long-acting beta-2 agonist (LABA)]. The aim of this study was to compare the efficacy and safety of long-acting muscarinic antagonists (LAMA) add-on to medium-dose ICS/LABA in patients at GINA 2022 step 4.

Methods: This post hoc analysis of the IRIDIUM study evaluated the change from baseline in trough forced expiratory volume (FEV₁ ) in patients receiving medium-dose MF/IND/GLY versus high-dose MF/IND and high-dose FLU/SAL at Week 26. Other outcomes included improvement in lung functions [peak expiratory flow (PEF), forced vital capacity (FVC), forced expiratory flow between 25% and 75% of the FVC (FEF)_25-75%)], asthma control [Asthma Control Questionnaire (ACQ-7)], responder analysis (≥ 0.5 unit improvement in ACQ-7), and reduction in asthma exacerbations at Weeks 26 and 52.

Results: A total of 1930 patients were included in this analysis. Medium-dose MF/IND/GLY improved trough FEV₁ versus high-dose MF/IND (Δ 41 mL; 95% CI - 7-90) and high-dose FLU/SAL (Δ 88 mL; 95% CI 39-137) at Week 26 which were sustained until Week 52. Exacerbation rates were 16% lower with medium-dose MF/IND/GLY versus high-dose MF/IND for all (mild, moderate, and severe) exacerbations and 21-30% lower versus high-dose FLU/SAL for all (mild, moderate, and severe), moderate or severe, and severe exacerbations over 52 weeks. Further improvements in other lung functions were observed with medium-dose MF/IND/GLY. No new safety signals were identified.

Conclusion: Medium-dose MF/IND/GLY improved lung function and reduced asthma exacerbations compared to high-dose ICS/LABA and may be an undervalued option in patients at GINA 2022 step 4.

Trial registration: ClinicalTrials.gov Identifier: NCT02571777.

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在 GINA 第 4 步：IRIDIUM 分析中使用莫美沙松/茚达特罗/甘草酸铵三联疗法或加倍 ICS/LABA 剂量。

导言：GINA 指南建议将增加吸入式皮质类固醇（ICS）的剂量作为 GINA 第 4 步[使用中等剂量 ICS/长效 beta-2 激动剂（LABA）的哮喘控制不佳]患者的阶梯治疗方案。本研究的目的是比较长效毒蕈碱拮抗剂（LAMA）在中剂量 ICS/LABA 基础上对 GINA 2022 第 4 步患者的疗效和安全性：这项IRIDIUM研究的事后分析评估了接受中等剂量MF/IND/GLY与大剂量MF/IND和大剂量FLU/SAL治疗的患者在第26周时的谷值用力呼气容积（FEV1）与基线相比的变化。其他结果包括肺功能改善[呼气峰流速（PEF）、用力肺活量（FVC）、25% 至 75% FVC 之间的用力呼气流速（FEF)25-75%）]、哮喘控制[哮喘控制问卷（ACQ-7）]、应答者分析（ACQ-7 改善≥ 0.5 个单位），以及第 26 周和第 52 周哮喘加重减少：本次分析共纳入了 1930 名患者。在第26周，中剂量MF/IND/GLY与大剂量MF/IND（Δ 41 mL; 95% CI - 7-90）和大剂量FLU/SAL（Δ 88 mL; 95% CI 39-137）相比，改善了谷值FEV1，这种改善一直持续到第52周。在52周内，中剂量MF/IND/GLY与大剂量MF/IND相比，所有（轻度、中度和重度）加重率降低了16%，与大剂量FLU/SAL相比，所有（轻度、中度和重度）、中度或重度和严重加重率降低了21%-30%。中剂量MF/IND/GLY可进一步改善其他肺功能。未发现新的安全信号：与大剂量ICS/LABA相比，中剂量MF/IND/GLY可改善肺功能并减少哮喘加重，可能是GINA 2022第4步患者的一种价值被低估的选择：试验注册：ClinicalTrials.gov Identifier：试验注册：ClinicalTrials.gov Identifier：NCT02571777。

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来源期刊

Pulmonary Therapy Medicine-Pulmonary and Respiratory Medicine

CiteScore

5.20

自引率

3.30%

发文量

审稿时长

6 weeks

期刊介绍： Aims and Scope Pulmonary Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from pre-clinical, clinical (all phases), observational, real-world, and health outcomes research around the use of pulmonary therapies, devices, and surgical techniques. Areas of focus include, but are not limited to: asthma; chronic obstructive pulmonary disease; idiopathic pulmonary fibrosis; pulmonary hypertension; cystic fibrosis; lung cancer; respiratory tract disorders; allergic rhinitis and other respiratory allergies; influenza, pneumococcal infection, respiratory syncytial virus and other respiratory infections; and inhalers and other device therapies. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Pulmonary Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. Rapid Publication The journal’s publication timelines aim for a rapid peer review of 2 weeks. If an article is accepted it will be published 3–4 weeks from acceptance. The rapid timelines are achieved through the combination of a dedicated in-house editorial team, who manage article workflow, and an extensive Editorial and Advisory Board who assist with peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid, efficient communication of the latest research and reviews, fostering the advancement of pulmonary therapies. Open Access All articles published by Pulmonary Therapy are open access. Personal Service The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning authors will always have an editorial contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE, GPP and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research. 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