Table 3.

Examples of Real-World Studies for COPD Pharmacotherapies

Study Name	Study Type	Study Aim/Results
Observational studies
DACCORD80	Real-life, prospective, noninterventional study in which patients were treated at the physician’s discretion (N=1258)	No increased exacerbation risk in over 2 years of follow-up in patients with ICS withdrawal compared with continuation of ICS therapies for COPD Patient treatment groups may not have been directly comparable because of lack of randomization and problems of severity matching
OPTIMO91	Real-life, prospective study in which patients were treated at the physician’s discretion (N=914)	No increase in exacerbation risk or deterioration in lung function upon ICS withdrawal from maintenance therapy (ICS + LABA) in patients with moderate COPD and low exacerbation risk Results from prospective randomized controlled trials need further confirmation because of lack of randomization, variable COPD severity, and cross-over between treatments
Samp et al 201792	Retrospective observational study based on an insurance claims database that included COPD patients in the United States treated with LAMA + LABA or ICS + LABA (N=478,772)	LAMA + LABA and LABA + ICS had similar effectiveness as measured by exacerbation rates in COPD patients
Voorham et al 201893	Matched historical cohort study conducted using records from the OPCRD and CPRD primary care databases (N=1647)	Significant reduction in exacerbation risk was observed with triple vs dual bronchodilator therapy, with a larger reduction in frequent exacerbators
Price et al 201894	Matched historical cohort study of real-life management of COPD patients with or without comorbid asthma Data from the OPCRD and CPRD primary care databases on patients prescribed the salbutamol comparator or a reference product were evaluated (N=1191)	The salbutamol comparator was noninferior to the reference product for the rate of moderate and severe COPD exacerbations after matching for demographic variables, indicators of disease severity, and baseline maintenance medication
Pragmatic nonrandomized controlled trial
Nyberg et al 201795	Prospective, multicenter, 12-month trial with planned enrollment of 96 patients with COPD from six participating primary care units in Sweden (N=96)	Results awaited The trial aims to evaluate the feasibility of the study design and procedures that consider the effectiveness of the COPD-web, a novel intervention, which is an internet-based program to support self-management strategies
Pragmatic randomized controlled trial
CRYSTAL96	Prospective, multicenter, 12-week, open-label, PrCT in COPD patients with moderate airflow limitation (N=4389)	Indacaterol + glycopyrronium improved lung function and dyspnea after direct switch from previous treatments, either ICS + LABA or LABA or LAMA monotherapy
Salford Lung Study81,82	Prospective, multicenter, 12-month, open-label, phase 3 PrCT in COPD patients receiving regular maintenance via inhaler therapy (N=2799)	Fluticasone furoate + vilanterol (ICS + LABA) delivered via a novel dry powder inhaler lowered the rate of exacerbations vs usual care without increasing the risk of serious adverse events
AIRWISE85	Prospective, multicenter, 12-month, open-label, phase 4 PrCT with a planned enrollment of 3200 patients across community-based sites (N=3200 estimated)	Results awaited; estimated primary completion date: February 23, 2021 The aim of the study is to compare the time to first moderate or severe COPD exacerbation in patients not controlled on their current therapy, randomized to tiotropium + olodaterol (LAMA + LABA) vs triple therapy (LAMA + LABA + ICS) over 12 months
RELIANCE86	Multicenter, 36-month, parallel-group, noninferiority, phase 3 study with a planned enrollment of 3200 patients	Currently recruiting; estimated primary completion date: February 2023 The aim of the study is to compare the effectiveness of roflumilast therapy vs azithromycin to prevent hospitalization or death in patients at a high risk of COPD exacerbations

Abbreviations: COPD, chronic obstructive pulmonary disease; CPRD, Clinical Practice Research Datalink; ICS, inhaled corticosteroid; LABA, long-acting β₂-agonist; LAMA, long-acting muscarinic antagonist; OPCRD, Optimum Patient Care Research Database; PrCT, pragmatic clinical trial.