Chronic Obstructive Pulmonary Disease (COPD) is the third most common cause of death. The main complaints of patients with COPD are breathlessness and a productive cough, and COPD patients often have periods where their symptoms worsen. The goals of COPD treatment are to reduce symptoms, reduce the periods of worsening of symptoms (called exacerbations), and improve health status and exercise tolerance. Currently, COPD patients are treated with drugs that open airways or reduce inflammation in the lung. For patients with severe disease, a combination of two or three types of drugs is recommended. In recent years, there has been an increase in the use of a combination of three different types of drugs called multiple inhaler triple therapy. Few studies have reported on the treatment patterns of this newly emerging combination treatment. Thus, this study aims to describe multiple inhaler triple therapy use in COPD patients in a primary care setting, including duration of therapy, clinical characteristics, and patient and disease factors that may play a role in the prescribing patterns.
The purpose of this study is to identify and characterize a cohort of COPD patients who initiate an inhaled triple regimen (LAMA+LABA+ICS by either using three separate therapies or a monotherapy coupled with a fixed combination dual therapy). In a cohort of COPD patients who were actively registered in CPRD practices, we will describe the patients' demographics, disease burden, and heath care resource utilization in the 12 months prior to initiating inhaled triple therapy. In addition, we will describe what maintenance treatment the patient was on prior to stepping-up to inhaled triple therapy, the duration of triple use over 12 months, and the treatment modification that lead to the discontinuation of triple therapy. There will be two distinct study-time periods for data collection. The first will begin in mid-2011 to allow for capture of possible treatment patterns before the approval of the LAMA/LABA therapy and the second will begin mid-2013, to capture treatment patterns after the LAMA/LABA drug was approved, which came to market in early 2013 as part of the triple regimen.
Patient demographics
- Respiratory history and disease severity
- Respiratory medications
- Healthcare resource utilisation (including rates of primary-care consultations and unscheduled, non-COPD-related hospitalisations)
Leah Sansbury - Chief Investigator - GlaxoSmithKline - UK
Leah Sansbury - Corresponding Applicant - GlaxoSmithKline - UK
Joe Maskell - Collaborator - Amgen Ltd
Sarah Landis - Collaborator - BioMarin Pharmaceutical Inc.
HES Admitted Patient Care;Patient Level Index of Multiple Deprivation