Steroid inhalers are shown to be beneficial for treating some people with a long term lung disease, often caused by smoking and lung inflammation, known as chronic obstructive pulmonary disease (COPD). However, people with COPD are not all the same; there are differences in the underlying causes of lung inflammation, other illnesses, and patient factors, such as smoking. Due to these variations, there is uncertainty as to which people with COPD will benefit most from steroid inhalers. There may be some people who are receiving steroid inhalers that are gaining no benefit to their lung disease, but will be experiencing some of the significant and extensive list of side effects; such as mouth and lung infections, diabetes and brittle bones. This research will use the Clinical Practice Research Datalink (CPRD) to determine which of the differences in people with COPD, as stated above, affect who is more likely to benefit from these inhalers; enabling clinicians to identify them and prescribe accordingly. This will prevent people who will not benefit from this type of medicine from receiving it and the extensive adverse effects.
Advances have been made in identifying factors in people with COPD who may gain more benefit from inhaled corticosteroids (ICS), regardless of the severity of their disease. Such factors include inflammation caused by eosinophilia, non-smoking status and co-diagnosis of asthma. It is postulated that ICS will be more beneficial for people with these factors due to underlying lung inflammation caused by eosinophils, which is known to be highly responsive to ICS. This research will determine if the aforementioned variables have an effect on the effectiveness of ICS in people with COPD. The Clinical Practice Research Datalink (CPRD) will be analysed. Inclusion criteria are all patients with a diagnosis of COPD, confirmed by spirometry between 2004 and 2013 and who have received at least one COPD medication. Data from the CPRD database will be linked to hospital episode statistics (HES) for hospitalisations due to COPD exacerbations. Survival analysis (using Cox’s Regression) will be used to assess time to exacerbation, time to hospitalisation after initiation of ICS, and time to death versus people with COPD who have never received an ICS. There will be a sub-group analysis of co-variates, including those with an asthma diagnosis, smoking status and eosinophilia. In addition time series analysis, using a panel data model will be undertaken to assess rate of decline of lung function and yearly exacerbation and hospitalisation rates in those patients who have over 50% persistence with ICS, with asthma diagnosis, smoking status and eosinophilia variables.
Primary:
• Exacerbations of COPD
• Lung function, measured by FEV1
Secondary
• Hospital admissions due to COPD exacerbation download
• Time to exacerbation after initiation of therapy
• Time to hospitalisation with COPD exacerbation after initiation of therapy
• All-cause mortality
• Respiratory-cause mortality
Roger Knaggs - Chief Investigator - University of Nottingham
Kimberley Sonnex - Corresponding Applicant - University of Nottingham
Harmony Otete - Collaborator - University Of Central Lancashire
HES Admitted Patient Care;ONS Death Registration Data;Practice Level Index of Multiple Deprivation