Title of Research Proposal: Withdrawing inhaled corticosteroid (ICS) treatment in people with COPD a real world study.
Potential Conflicts of Interest: None related to this work.
People with chronic obstructive pulmonary disease (COPD) are commonly treated with short or long-acting bronchodilator inhalers and with inhaled corticosteroids (ICS) if symptoms persist. Recent studies have shown that ICS use slows down lung function decline and decreases the risk of exacerbations 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 those who continue to smoke. Recently a study called WISDOM 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 was a randomised control trial, which 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 general/non-specific population of people with COPD.
A Randomised, Double-blind, Active-controlled Study to Evaluate the Impact of Stepwise Withdrawal of Inhaled Corticosteroid Treatment in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease (COPD) on Optimized Bronchodilator Therapy
Sponsor: Boehringer Ingelheim
Study ID: NCT00975195
Sponsor ID: 352.2046
We will use Clinical Practice Research Datalink GOLD (CPRD) primary care data linked with Hospital Episode statistics (HES) data. We have submitted an ISAC application to use the CPRD data concomitantly with this application, which has been accepted. We will compare the data but not combine the data. We will obtain individual patient data from the WISDOM trial and match individual participants with similar people in the anonymised electronic healthcare record (EHR) database, CPRD. Using propensity score cohort methodology, we will estimate the effect of inhaled corticosteroid (ICS) withdrawal on time to first moderate or severe exacerbation, spirometry findings, health status and dyspnoea. The results will be compared with the WISDOM findings to determine the utility of CPRD records for measuring medication effectiveness in COPD. Using the methodological template developed in Objective 1, we will determine the effect of ICS withdrawal on time to first moderate or severe exacerbation, spirometry findings, health status and dyspnoea in people not eligible for the WISDOM study (e.g. people aged >80 years or with substantial comorbidity) and look separately at important subgroups e.g. those with and without underlying cardiovascular disease. In addition we will consider other ICS related end points such as exacerbation rate, pneumonia and hypertension.
Data Contributor: I WILL BRING MY OWN
Study ID: Clinical Practice Research Datalink
Update: This data request was withdrawn on 5 October 2020 by the researcher.