Investigating biases in observational studies of inhaled corticosteroids and the risk of COVID-19-related outcomes

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47886
• EU PAS number:
  EUPAS47885
• Study ID:
  47886
• Official title and acronym:
  Investigating biases in observational studies of inhaled corticosteroids and the risk of COVID-19-related outcomes
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  Inhaled corticosteroids (ICS) are anti-inflammatory drugs widely used as maintenance medications in asthma and chronic obstructive pulmonary disease (COPD). At the beginning of the COVID-19 pandemic, there was interest in ICS as potential disease-modifying drugs in COVID-19. Several observational studies investigated the effects of ICS on COVID-19 outcomes but found inconsistent results that may be affected by biases. The aim of this study is to investigate the effects of ICS at different stages of the COVID-19 disease pathway among patients with asthma or COPD, and apply methods of quantitative bias analysis (QBA) to these effect estimates to account for potential biases arising in these estimates of association. This study will use cohorts of patients with asthma and COPD, respectively, to investigate the association between ICS use compared to use of a non-ICS active comparator and SARS-CoV-2 infection, COVID-19 hospitalisation, and COVID-19 death. All analyses will be conducted separately for an asthma and COPD cohort and for the first and second wave of COVID-19. CPRD data will be linked to HES data to determine COVID-19 related hospitalisations, and to the ONS death registry to determine COVID-19 related deaths. The association between ICS prescription and each outcome will be estimated using a Cox regression model to calculate hazard ratios and 95% confidence intervals, with confounding adjustment using multivariable regression and propensity scores. QBA will be used to account for potential sources of bias in these estimates of association, including exposure and outcome misclassification, residual confounding and selection bias. This project will allow an evaluation of whether and how more widespread use of QBA may have allowed researchers to make better inferences using observational data about the role of ICS in COVID-19. Outputs from this project will provide recommendations and tools to help researchers implement QBA in pharmacoepidemiologic studies.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Electronic Health Records (EHR) Research Group, London School of Hygiene & Tropical Medicine (LSHTM)

United Kingdom

Study timelines

Date when funding contract was signed

Actual: 19/04/2021

Study start date

Actual: 01/03/2017

Data analysis start date

Planned: 02/01/2023

Date of final study report

Planned: 31/10/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline

Study protocol

Initial protocol

ICS_COVID Encepp

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable