Therapy decisions in newly diagnosed COPD patients in GOLD groups A and B- follow up of patients receiving different therapies. A non-interventional study using the Clinical Practice Research Datalink (CPRD) database.

Study type
Protocol
Date of Approval
Study reference ID
16_173
Lay Summary

Chronic obstructive pulmonary disease (COPD) is a collection of lung diseases that narrow the airways, causing breathing difficulties and other symptoms such as persistent cough or chest infections. People with COPD often receive treatment in the form of inhalers, and different types of inhaler are available. This study aims to compare steroid inhalers, also called corticosteroid inhalers which work by reducing the inflammation in the airways, with other types of inhaler used in COPD to see whether these affect the number of times a person with COPD will need to visit their GP or the hospital. This is important as we need to know whether these treatments help improve the lives of people with COPD.

Technical Summary

This study is a non-interventional cohort study using existing data provided by the Clinical Practice Research Datalink (CPRD), to gain detailed insights on the characteristics of COPD patients treated with an Inhaled Corticosteroid (ICS) containing therapy or non-ICS containing therapy. Recent research suggests that many patients appear to be inappropriately prescribed ICS at their initial COPD diagnosis, regardless of lung function severity. The potential effect that this may have on outcomes after diagnosis has yet to be investigated. The main objective of this study is to compare health care resource use between patients prescribed an ICS and non-ICS containing therapy after COPD diagnosis. The results from this study will be used to support the scientific understanding of how choice of therapy may influence COPD outcomes. Comorbidities and demographic information will be described for the groups of patients initiated on different therapies. Multivariate regression models will be used to compare outcomes between the two propensity-matched groups.

Health Outcomes to be Measured

We aim to compare the following disease outcomes: Health Resource Use - (all-cause and COPD related) 1. Average GP visit duration of consultations 2. Number of interactions with a health care professional per month 3. Rate of hospital admissions 4. Rate of SAMA/SABA prescriptions defined using CPRD prescription read codes 5. Rate of referrals

Collaborators

Chris D Poole - Chief Investigator - Digital Health Labs Limited
Alicia Gayle - Corresponding Applicant - Imperial College London
James Clark-Wright - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
Nick Ramscar - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc

Linkages

HES Admitted Patient Care;HES Outpatient;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation