People with chronic obstructive pulmonary disease (COPD) are treated with inhalers to alleviate symptoms and ease breathing (short and long-acting bronchodilator inhalers), and with inhalers that include steroids (inhaled corticosteroids (ICS)) if symptoms persist. A study in which people were randomly assigned to drug groups (randomised control trial), called The Study to Understand Mortality and Morbidity in COPD (SUMMIT), showed that ICS use slows down lung function decline and decreases the risk of periods of symptom worsening (exacerbations of COPD) in people with COPD. All individuals have some decline in lung function over time, particularly in later life, but people with COPD lose lung function faster than the general population, particularly in smokers. Recently another randomised control trial called Withdrawal of Inhaled Steroids during Optimized Bronchodilator Management (WISDOM) trial showed that people with COPD who started on medication including ICS but then stopped using ICS had the same lung function decline and risk of exacerbations as those who stayed on medication including ICS. This study included specific people with COPD and may not represent the true population of people with COPD. Using statistical models, we will replicate the WISDOM study using a more generalizable population of people with COPD.
Chronic Obstructive Pulmonary Disease (COPD) patients are treated with short/long-acting bronchodilator inhalers. If symptoms persist or patients experience exacerbations of COPD (AECOPD) they are prescribed inhaled corticosteroids (ICS). The risks and benefits of ICS in the treatment of COPD is debated however, the Study to Understand Mortality and Morbidity in COPD (SUMMIT) suggested that ICS are associated with reduced lung function (FEV1) decline, and decreased risk of AECOPD. In contrast, a recent randomised control trial (RCT), the Withdrawal of Inhaled Steroids during Optimized Bronchodilator Management (WISDOM) trial, investigated whether FEV1 decline in COPD patients on triple therapy, who withdrew from ICS, differed from those who remained on triple therapy. Results showed no difference in rate of FEV1 decline between the two groups. Whilst well-performed RCTs allow causal effects of drug treatments to be inferred, they include very specific COPD populations and results may not be generalizable to the general COPD population. Observational studies are therefore needed to assess associations in a wider population of COPD patients. Using mixed effects linear regression and Cox-proportional hazard regression we will investigate the association between risk of AECOPD and FEV1 decline in COPD patients on triple therapy and those who withdraw from ICS.
Time to first exacerbation of COPD (AECOPD)
Change from baseline in FEV1
Time to first severe AECOPD
Adverse events (pneumonia, cardiac event, stroke)
Number of moderate or severe AECOPD
Change from baseline in dyspnoea (using modified Medical Research Council (mMRC))
Jennifer Quint - Chief Investigator - Imperial College London
Hannah Whittaker - Corresponding Applicant - Imperial College London
Debbie Jarvis - Collaborator - Imperial College London
Ian Douglas - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Kevin Wing - Collaborator - London School of Hygiene & Tropical Medicine ( LSHTM )
Steven Kiddle - Collaborator - AstraZeneca Ltd - UK Headquarters
HES Admitted Patient Care;Patient Level Index of Multiple Deprivation