For people with chronic obstructive pulmonary disease (COPD), standard maintenance inhaler treatments consist of inhaled corticosteroids (ICS) and long acting bronchodilators. Principal classes of long acting bronchodilators include long-acting beta-2-agonists (LABA) and long-acting muscarinic antagonists (LAMA). The effects of these inhalers are usually measured by a reduction in occurrence of exacerbations defined as worsening in COPD symptoms and have been mainly studied in highly controlled randomized clinical trial (RCT) settings. Current evidence from RCTs indicates that combining ICS with LABAs and LAMAs may provide rapid and sustained improvements that extend beyond using a single inhaler therapy. In this study, we will compare the effects of triple therapy treatments (ICS/LABA/LAMA) versus LAMA treatment alone in patients with COPD, in a real-world setting, using CPRD GOLD data linked with Hospital Episode Statistics (HES). The occurrence of COPD exacerbations will be analysed to assess the effect of therapies. This study will provide epidemiological data to support future RCT design.
For people with chronic obstructive pulmonary disease (COPD), standard maintenance inhaler treatments consist of ICS and long acting bronchodilators. Principal classes of long acting bronchodilators include long-acting beta-2-agonists (LABA) and long-acting muscarinic antagonists (LAMA). Treatment effects are usually measured by a reduction in occurrence of exacerbations and have been mainly studied in randomized controlled clinical trials (RCT). These studies indicate that combining inhaled corticosteroids (ICS) with LABAs and LAMAs provides rapid and sustained improvements that extend beyond monotherapy alone. There is a need for real-world effectiveness data regarding COPD treatment in order to demonstrate that improvements in lung function translate into reductions in exacerbations, hospitalizations, or morbidity. For comparative effectiveness research to impact COPD patients with multiple illnesses, a shift needs to occur from the heavy reliance on controlled efficacy studies in highly selected populations to observational studies with rigorous study design. Electronic medical records or primary health care data such as the CPRD GOLD provide a platform for these observational studies. We will compare the relative effects of triple therapy treatments (ICS/LABA/LAMA) versus LAMA treatment alone on exacerbations in patients with COPD in a real world setting. This study will provide epidemiological data to support RCT design.
COPD exacerbations; Pneumonia; Mortality.
Claudia Cabrera - Chief Investigator - Astra Zeneca R&D Molndal Sweden
Claudia Cabrera - Corresponding Applicant - Astra Zeneca R&D Molndal Sweden
Celine Quelen - Collaborator - Creativ-Ceutical ( do not use )
Jennifer Quint - Collaborator - Imperial College London
Kieran Rothnie - Collaborator - GlaxoSmithKline Services Unlimited (UK)
HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation