Unmet Needs, Symptom Burden, and Health Care Utilisation of Chronic Obstructive Pulmonary Disease (COPD) Patients Receiving Respiratory Maintenance Therapy in the United Kingdom (UK)

Study type
Protocol
Date of Approval
Study reference ID
18_094
Lay Summary

Chronic Obstructive Pulmonary Disease (COPD) is the third most common cause of death among adults and is a chronic inflammatory lung disease that blocks airflow from the lungs. The main complaints of patients with COPD are breathing difficulty, cough, and wheezing, and COPD patients often have periods where their symptoms worsen. The Global initiative for chronic Obstructive Lung Disease (GOLD) strategy categorizes COPD patients into four disease severity groups (GOLD Groups A-D) based on the patients' breathlessness and worsening of symptoms (called exacerbations). In addition, this strategy document proposes treatment choices suitable for each of these four patient groups. The goals of COPD treatment are to reduce symptoms, reduce the periods of exacerbations, and improve health status. Despite these recommendations, patients do not always receive the recommended treatment or their treatment is not appropriately changed when their symptoms worsen. This study will evaluate the number and characteristics of patients on treatment for their COPD, and describe their symptoms and how often they seek medical care while on treatment.

Technical Summary

Chronic obstructive pulmonary disease (COPD) is a heterogeneous group of disorders including chronic bronchitis and emphysema that is characterised by airflow obstruction, that is both progressive and largely irreversible. Global initiative for chronic Obstructive Lung Disease (GOLD) strategy document proposes suitable first and secondary choice pharmacologic therapies depending on disease severity (GOLD 2017). Despite these evidence-based guidelines, observational studies have shown that routine practice of prescribing treatment for COPD is not always aligned with these recommendations. In addition, some patients who continue to have worsening of symptoms and exacerbations are not offered a step-up or change in long-acting bronchodilator (LABD) therapy. It is therefore important to understand whether there are patient and disease factors that contribute to the pattern of prescribing. In addition, in order to improve effectiveness of health-care delivery and improve patients' lives, it is vital to understand which patients are reporting poor disease control, their characteristics and outcomes. The current study aims to characterise COPD patients who initiate therapy with LABD maintenance medication and how long they persist with the specific therapy. We will also describe COPD disease burden and health care utilization over 12 months of follow-up by these treatment groups.

Health Outcomes to be Measured

Patient demographics
- Respiratory history and disease severity
- Respiratory medications
- Healthcare resource utilisation (including rates of primary-care consultations and unscheduled, non-COPD-related hospitalisations)

Collaborators

Leah Sansbury - Chief Investigator - GlaxoSmithKline - UK
Leah Sansbury - Corresponding Applicant - GlaxoSmithKline - UK
Chanchal Bains - Collaborator - GlaxoSmithKline - UK
Sarah Landis - Collaborator - BioMarin Pharmaceutical Inc.

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient