Withdrawal of historical inhaled corticosteroids in primary care using electronic records

Date of Approval
Application Number
Technical Summary

The Global Initiative for Chronic Obstructive Lung Disease (GOLD) is an international organization that releases recommendations for COPD prevention, diagnosis and management. The recommendations for use of inhaled corticosteroids (ICS) state that ICS should be reserved for COPD patients with severe/very severe disease (GOLD C/D with frequent or severe exacerbations). Furthermore biomarkers and other patient phenotypes have been explored to best identify patients that would benefit most from ICS therapy. As many mild COPD patients have been identified as inappropriately prescribed ICS, withdrawal of ICS has been proposed. There is limited evidence around how to withdraw patients and which patients will succeed outside of a clinical trial setting. This study is a non-interventional cohort study using existing data (CPRD), to gain detailed insights on the withdrawal of maintenance ICS. The main objective of this study is to describe the trends in ICS withdrawal and identify characteristics associated with ICS-free time. The number of patients withdrawing over time will be described and a cox regression model will be used to determine the factors associated with ICS-free time and Kaplan Meier curves will be drawn to estimate 12-month withdrawal success (defined as time without ICS). The results from this study will be used to support the scientific understanding of current practice, to understand which patients are having this therapy withdrawn and whether they may be predictive characteristics to aid understanding of where this may be successful.

Health Outcomes to be Measured

Primary Outcomes:
- Characteristics of patients at index date of withdrawal
- Number of patients withdrawing by calendar year and region
- Time without ICS (measured in months) following withdrawal.
This is defined as the time between index (Figure 3) to:
• date of subsequent ICS prescription (in any combination)
• or one of:
• loss of follow up, end of study period, death
- Number of exacerbations during withdrawal period: mild/moderate and severe (hospitalised) exacerbations

Secondary Outcomes
- Cough-related consultations
- Sputum-related consultations
- SABA/SAMA prescriptions

Exploratory Outcomes
- Change in MRC score
- Pneumonia episodes
- Pneumonia hospitalisations
- Death (all-cause)


Ruth Farmer - Chief Investigator - Boehringer-Ingelheim Pharmaceuticals, Inc
Ruth Farmer - Corresponding Applicant - Boehringer-Ingelheim Pharmaceuticals, Inc
Helen Ashdown - Collaborator - University of Oxford
James Chalmers - Collaborator - University of Dundee
Kevin Morris - Collaborator - Boehringer-Ingelheim - UK
Scott Dickinson - Collaborator - Boehringer-Ingelheim - UK
Smit Patel - Collaborator - Boehringer-Ingelheim International GmbH


HES Admitted Patient Care;PAT IDs