Trends and factors associated with therapy decisions in newly diagnosed COPD patients in GOLD groups A and B.
A non-interventional study using the Clinical Practice Research Datalink (CPRD) database

Study type
Protocol
Date of Approval
Study reference ID
15_237
Lay Summary

This study plans to investigate what therapies people are prescribed when they are first diagnosed with mild or moderate chronic obstructive pulmonary disease (COPD), a progressive disease that makes it hard to breathe.

European treatment guidelines recommend that inhaled corticosteroids (ICS), a medicine often known as steroids which reduces swelling and reduce the body's own defences, are reserved for COPD patients with severe or very severe disease, but there is evidence that ICS is frequently used in mild and moderate patients.

This study will investigate the factors which affect whether a GP decides to prescribe ICS treatment or a non-ICS treatment combination to a mild/moderate patient when they are first diagnosed with COPD.

We also plan to look at the prescribing trends in mild/moderate COPD patients over the last 10 years, to see whether the pattern of prescribing to these patients has changed over time.

Technical Summary

This study is a non-interventional cohort study using existing data (CPRD), to evaluate the factors associated with therapy decisions in newly diagnosed COPD patients in GOLD (Global Initiative for Chronic Obstructive Lung Disease1) groups A and B. The GOLD stages of airflow obstruction and dyspnea are widely used to quantify COPD severity into four categories, A (mild), B (moderate) C (severe) and D (very severe). Severity is determined by combining data from response to the MRC dyspnea questionnaire, the number of exacerbations in the past 12 months, and the FEV1 score (as a % of predicted).

The main objective is to assess which patient or practice characteristics influence the initial choice of ICS therapy combinations over non ICS therapy combinations at initial diagnosis of mild/moderate COPD.

The results from this study will be used to support the scientific understanding of how COPD patients in GOLD groups A and B are treated, and which patients are more likely to be inappropriately treated with ICS.

Comorbidities and demographic information will be described for the groups of patients initiated on different therapy combinations. Logistic regression will be used to investigate the factors which affect whether a GOLD A/B COPD patient is treated with an ICS containing therapy combination when diagnosed with COPD or a non-ICS therapy.

We will also investigate the differences in patient and practice characteristics between GOLD A and B patients prescribed different therapy combinations at initial COPD diagnosis, and examine the trend in prescribing of COPD therapies to patients in GOLD groups A and B at initial COPD diagnosis over the last 10 years.

Collaborators

Anna Scowcroft - Chief Investigator - UCB Pharma Ltd
Andrew Ternouth - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
Nick Ramscar - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc