Chronic obstructive pulmonary disease (COPD) is a respiratory condition affecting airflow in the lungs, leading to symptoms such as shortness of breath and tightness in the chest. It is not reversible and becomes gradually worse over time. No single drug has been shown to prevent progressive loss of lung function. However, if treated early with a triple combination of inhaled drugs, relevant effects may be achieved. The proposed study aims to explore lung function decline over time, in patients at the early stages of COPD who are receiving various types of treatment. Using several years of anonymous patient information from General Practices, the study will initially assess an existing tool that predicts whether patients with COPD will have a rapid decline in lung function. Such tools can be highly useful in planning treatment strategies and it is important to investigate whether they are accurate. The study will then identify those patients who are likely to have a rapid decline, separate them by the treatment they were receiving, and compare their lung function decline over time. This will obtain much needed evidence of whether decline can be reduced by particular treatment regimens and could lead to improved management of this condition.
The study aims to identify patients who are at high risk of rapid lung function decline and to study the effectiveness of COPD maintenance therapies. Patients diagnosed with mild to moderate COPD, a history of smoking and repeated FEV1 measurements will be included. Initially, the study will validate an existing prediction model for FEV1 decline under minimal therapy, comparing observed and predicted FEV1 values. The subgroup of patients with high risk (>80%) of rapid decline (≥40 ml/year) will be characterised at time of diagnosis and initiation of maintenance therapy. Differences between individual’s observed and predicted FEV1 values (calculated from the validated prediction model or a newly developed model) will be described after initiation of maintenance therapies. Analyses will be performed for patients with first maintenance therapy being a single inhaler, dual therapy or triple therapy, separately. In addition, patients initiated on triple therapy will be matched to similar patients on minimal therapy, based on potential confounders. A multilevel model for change (mixed linear regression) will be used to compare the rate of FEV1 decline between matched patients. Conditional negative binomial regression and stratified Cox-regression will be used to analyse differences in exacerbation rates and time to first COPD-related hospitalisation respectively.
David Price - Chief Investigator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Marjan Kerkhof - Corresponding Applicant - OPRI - Observational and Pragmatic Research Institute Pte Ltd
Claudia Cabrera - Collaborator - Astra Zeneca R&D Molndal Sweden
Derek Skinner - Collaborator - Research in Real Life ltd.( RiRl )
Marcus Ngantcha - Collaborator - Cambridge Research Support
Paul M. Dorinsky - Collaborator - Pearl Theraputics
Sen Yang - Collaborator - OPRI - Observational and Pragmatic Research Institute Pte Ltd
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;Practice Level Index of Multiple Deprivation