![]() The study protocol was prepared and published via PROSPERO (#CRD42018102125). We followed the Preferred Reporting Items for Systematic Reviews and Meta Analyses (PRISMA) guidelines for conducting and reporting systematic reviews. In addition, we present and discuss the characteristics of each trial, highlighting how study design features could impact the interpretation of clinical trial results and cross-trial comparisons. ![]() We also present estimates of number needed to treat (NNT) and an overview of risks associated with treatment to support clinical decision making. We present the relative and absolute benefit of single-inhaler triple therapy overall and for specific patient subgroups for each trial. The main objective of this study was to conduct a systematic review of randomised controlled trials comparing the efficacy and safety of fixed-dose combinations of a LABA, LAMA and ICS (single-inhaler triple therapy) with LABA, LAMA, LABA/LAMA or LABA/ICS for the treatment of adult patients with COPD. To the best of our knowledge there are currently no systematic reviews that give a comprehensive and critical assessment of the evidence base for single-inhaler triple therapy.įollowing the GOLD 2019 update, such a review would provide insights into patients most suited to triple therapy, the strength of the evidence base and the need for future research. Second, the randomised controlled trial data for single-inhaler therapies will be used to inform the evidence base for triple therapy as a whole, therefore it is important to understand its strengths and limitations. First, important questions in clinical practice remain over the role of triple therapy, which include the magnitude of clinical benefit and the identification of patients with the best risk-benefit profile for treatment. ![]() A systematic and critical review of the evidence base for single-inhaler triple therapy is warranted to support clinical decision making for the following reasons. Recently, two single-inhaler triple therapies have received marketing authorisation from the European Medicines Agency and one other is in late-stage clinical development. However, evidence suggests that triple therapy is often over prescribed in clinical practice and used in patients who are not frequent exacerbators. Triple therapy, provided as multiple inhalers, has in pooled analyses been shown to improve lung function, health-related quality of life and exacerbations. Evidence suggests that dual therapy with LABA and inhaled corticosteroids (ICS) and the step up to triple therapy (LAMA/LABA/ICS) be considered for a select group of patients who continue to exacerbate despite appropriate treatment and/or features suggesting steroid responsiveness. In those patients with a high risk of exacerbations, therapy relies on a long-acting muscarinic antagonist (LAMA) or if a patient is highly symptomatic, dual therapy with a LAMA and a long-acting β 2 agonist (LABA). The 2019 Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy document, based on the best-available evidence from the published literature, recommend that choice of treatment depends on symptom and exacerbation severity. Pharmacological treatment relies predominately on inhaled bronchodilators and anti-inflammatory agents. Chronic obstructive pulmonary disease (COPD) is a leading cause of mortality and morbidity worldwide.
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