E-Thesis 153 views 45 downloads
STep DOWn InhAlers in the Real WorlD (TOWARD): a feasibility study / JOSEPH ANNANDALE
Swansea University Author: JOSEPH ANNANDALE
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Copyright: The Author, Joseph Alexander Annandale, 2023.
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Abstract
INTRODUCTIONCurrent clinical guidelines recommend the use of inhaler corticosteroids (ICS) in combination with long-acting bronchodilators in the management of chronic obstructive pulmonary disease (COPD). Despite their use being recommended in patients who exacerbate frequently, in practice they ar...
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Swansea University, Wales, UK
2024
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| Institution: | Swansea University |
| Degree level: | Master of Research |
| Degree name: | MSc by Research |
| Supervisor: | Lewis, K. E., and Hutchings, H. |
| URI: | https://cronfa.swan.ac.uk/Record/cronfa66145 |
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| Abstract: |
INTRODUCTIONCurrent clinical guidelines recommend the use of inhaler corticosteroids (ICS) in combination with long-acting bronchodilators in the management of chronic obstructive pulmonary disease (COPD). Despite their use being recommended in patients who exacerbate frequently, in practice they are more broadly prescribed potentially exposing patients to side effects but little or no benefit with a cost burden. Randomised studies with strict inclusion/exclusion criteria have demonstrated it is possible to safely stop an ICS. This feasibility study aimed to test a real-world protocol to stop ICS in patients with stable COPD, despite having the typical exclusion criteria seen in the randomised studies.METHODSStable participants with a confirmed diagnosis of COPD who were prescribed ICS as well as 2 long-acting bronchodilators were recruited. Those with an exacerbation within six weeks, a history of asthma or peripheral blood eosinophil count >600 dl/l were excluded. Participants were shown the four currently licensed dual long-acting bronchodilators combination inhalers and were asked to select one. After confirming effective inhaler technique, they were prescribed the combination inhaler. Participants were free to restart an ICS at any point. Lung function (FEV1) and quality of life scores (CAT) were recorded at baseline, 4 and 52-week visits. Exacerbations urequiring treatment were compared 12 months pre and post inhaler switch. Feasibility was measured using a Model with predefined criteria.RESULTSOf the 10 feasibility criteria 60% were met (participant follow up/completion; data collection, primary care access; cost savings) and 40% not met (recruitment targets; primary care staff participation; numbers completing study not on an ICS; exacerbation rates). 3 participants died within the study period but none attributed to their participation. 57% (n=37) of participants did not restart an ICS and there was no significant rise in exacerbation rates when compared to the 12 months prior to the study (p=0.229). There was an increase in hospital admission rate but still very low from 0.05/year to 0.2/year (p=0.007). There was no significant change in FEV1 (p=0.883) or CAT scores (p=0.662). Overall prescribing cost savings were significant and estimated at >£18K (p=<0.001). Analysis by outcome (those completing study on ICS and those not) demonstrated a clear difference in the 2 groups at baseline with those not restarting an ICS having less exacerbations in the 12 months prior to the study with better lung function and quality of life.DISCUSSIONThe results suggest that overall, the study protocols were safe with the potential to discontinue ICS therapy in some patients. The clear differences within the group at baseline may account for those needing to restart ICS therapy and appears those with more severe disease continued the decline in terms of exacerbations, lung function, quality of life and hospital admissions. These factors could be considered and potentially result in amendments to the study protocol for a future larger study. A larger study would be feasible but recruitment targets would need to be re-evaluated and who delivers the intervention considered, as Primary Care have no capacity to directly support such a study. |
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| Keywords: |
COPD, inhaled corticosteroids |
| College: |
Faculty of Medicine, Health and Life Sciences |