Treatment choice and outcomes associated with dry powder inhaler and Tiotropium Respimat monotherapy in COPD (chronic obstructive pulmonary disease) patients

Study type
Protocol
Date of Approval
Study reference ID
16_062
Lay Summary

This study aims to compare the burden of disease between two types of treatment device among people diagnosed with chronic obstructive pulmonary disease (COPD), a progressive disease that makes it hard to breathe. This study will investigate the difference between soft mist inhalers and dry powder inhalers as single medications used to treat COPD. How many resources (i.e. visits to the General Practitioner (GP)) these patients use, treatment outcomes (time on therapy, time to change in therapy), and how many health issues (sudden worsening of symptoms, change in lung function) they encounter over the course of their treatment period will be assessed.

Technical Summary

This study is a non-interventional cohort study using existing data (CPRD), to gain detailed insights on the characteristics of COPD patients treated with a dry powder inhaler (DPI) or Respimat. So far large scale clinical trials have shown no significant differences in patient outcomes such as exacerbations/ FEV1 etc.. This may be due to patients in these trials being educated in optimal inhaler use and adhering more than expected in the general population in real life. In real world practice, where adherence and inhaler technique can vary- inhaler type may influence patient outcomes. The main objective is to compare outcomes between patients prescribed a DPI and Tiotropium Respimat maintenance monotherapy; exacerbation rate, time on monotherapy, time to treatment step up (addition of LABA or ICS), treatment adherence, change in lung function and health care resource use. The results from this study will be used to support the scientific understanding of how choice of device 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.

Collaborators

Anna Scowcroft - Chief Investigator - UCB Pharma Ltd
Alicia Gayle - Corresponding Applicant - Imperial College London
Alicia Gayle - Collaborator - Imperial College London
Andrew Ternouth - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc
Gavin Chiu - Collaborator - Boehringer-Ingelheim Pharmaceuticals, Inc

Linkages

HES Admitted Patient Care