Withdrawal of inhaled corticosteroids from patients with COPD with mild or moderate airflow limitation in primary care: a feasibility randomised trial
Background Inhaled corticosteroids (ICS) are frequently prescribed outside guidelines to patients with chronic obstructive pulmonary disease (COPD) with mild/moderate airflow limitation and low exacerbation risk. This primary care trial explored the feasibility of identifying patients with mild/mode...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-08-01
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| Series: | BMJ Open Respiratory Research |
| Online Access: | https://bmjopenrespres.bmj.com/content/9/1/e001311.full |
| _version_ | 1811274955899273216 |
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| author | Nicholas Hart Mike Thomas Patrick Murphy Gill Gilworth Christopher J Corrigan PATRICK T WHITE Timothy H Harries |
| author_facet | Nicholas Hart Mike Thomas Patrick Murphy Gill Gilworth Christopher J Corrigan PATRICK T WHITE Timothy H Harries |
| author_sort | Nicholas Hart |
| collection | DOAJ |
| description | Background Inhaled corticosteroids (ICS) are frequently prescribed outside guidelines to patients with chronic obstructive pulmonary disease (COPD) with mild/moderate airflow limitation and low exacerbation risk. This primary care trial explored the feasibility of identifying patients with mild/moderate COPD taking ICS, and the acceptability of ICS withdrawal.Methods Open feasibility trial. Outcome measures included prevalence of suitable participants, feasibility of their identification, their willingness-to-accept open randomisation to ICS withdrawal or continuation over 6 months follow-up.Results 392 (13%) of 2967 patients with COPD from 20 practices (209 618 population) identified as eligible for ICS withdrawal by electronic search algorithm. After individual patient record review, 243 (62%) were excluded because of: severe airflow limitation (65, 17%); one or more severe or two or more moderate COPD exacerbations in the previous year (86, 22%); asthma (15, 4%); and severe comorbidities (77, 20%). After exclusion, 149 patients with COPD were invited to participate and 61 agreed to randomisation. At clinical assessment, 10 patients exhibited undocumented airflow reversibility (forced expiratory volume in 1 s (FEV1) reversibility >12% and >200 mL); 2 had suffered two or more undocumented, moderate exacerbations in the previous year; 7 had severe airflow limitation; and 2 had normal spirometry. Finally, 40 were randomised. One patient died and one was lost to follow-up. 18 (45%) of the 38 (10 withdrawal and 8 usual care) exhibited previously undocumented FEV1 variability suggestive of asthma, supported in the withdrawal group by significant associations with elevated fractional exhaled nitric oxide (p=0.04), elevated symptom score (p=0.04), poorer quality of life (p=0.04) and atopic status (p=0.01).Conclusions Identifying primary care patients with mild/moderate COPD suitable for ICS withdrawal is feasible but requires real-time verification because of unreliable recording of exacerbations and lung function. Suitable patients accepted randomisation to ICS withdrawal or continuation for the purposes of future studies. Follow-up compliance was high. Nearly 50% of participants with a diagnosis of mild/moderate COPD demonstrated previously undocumented FEV1 variability during follow-up, mandating monitoring for at least 6 months following withdrawal to exclude undiagnosed asthma. |
| first_indexed | 2024-04-12T23:28:12Z |
| format | Article |
| id | doaj.art-7e171787369845d1af628fb285abdf94 |
| institution | Directory Open Access Journal |
| issn | 2052-4439 |
| language | English |
| last_indexed | 2024-04-12T23:28:12Z |
| publishDate | 2022-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open Respiratory Research |
| spelling | doaj.art-7e171787369845d1af628fb285abdf942022-12-22T03:12:20ZengBMJ Publishing GroupBMJ Open Respiratory Research2052-44392022-08-019110.1136/bmjresp-2022-001311Withdrawal of inhaled corticosteroids from patients with COPD with mild or moderate airflow limitation in primary care: a feasibility randomised trialNicholas Hart0Mike Thomas1Patrick Murphy2Gill Gilworth3Christopher J Corrigan4PATRICK T WHITE5Timothy H Harries6Lane Fox Respiratory Unit, Guy`s and St Thomas` NHS Foundation Trust, London, UKPCPS, University of Southampton, Southampton, UKLane Fox Respiratory Unit, Guy`s and St Thomas` NHS Foundation Trust, London, UKSchool of Population Health and Environmental Sciences, King’s College London, London, UKDepartment of Asthma Allergy and Respiratory Science, King`s College London, London, UKSchool of Population Health and Environmental Sciences, King’s College London, London, UKSchool of Population Health and Environmental Sciences, King’s College London, London, UKBackground Inhaled corticosteroids (ICS) are frequently prescribed outside guidelines to patients with chronic obstructive pulmonary disease (COPD) with mild/moderate airflow limitation and low exacerbation risk. This primary care trial explored the feasibility of identifying patients with mild/moderate COPD taking ICS, and the acceptability of ICS withdrawal.Methods Open feasibility trial. Outcome measures included prevalence of suitable participants, feasibility of their identification, their willingness-to-accept open randomisation to ICS withdrawal or continuation over 6 months follow-up.Results 392 (13%) of 2967 patients with COPD from 20 practices (209 618 population) identified as eligible for ICS withdrawal by electronic search algorithm. After individual patient record review, 243 (62%) were excluded because of: severe airflow limitation (65, 17%); one or more severe or two or more moderate COPD exacerbations in the previous year (86, 22%); asthma (15, 4%); and severe comorbidities (77, 20%). After exclusion, 149 patients with COPD were invited to participate and 61 agreed to randomisation. At clinical assessment, 10 patients exhibited undocumented airflow reversibility (forced expiratory volume in 1 s (FEV1) reversibility >12% and >200 mL); 2 had suffered two or more undocumented, moderate exacerbations in the previous year; 7 had severe airflow limitation; and 2 had normal spirometry. Finally, 40 were randomised. One patient died and one was lost to follow-up. 18 (45%) of the 38 (10 withdrawal and 8 usual care) exhibited previously undocumented FEV1 variability suggestive of asthma, supported in the withdrawal group by significant associations with elevated fractional exhaled nitric oxide (p=0.04), elevated symptom score (p=0.04), poorer quality of life (p=0.04) and atopic status (p=0.01).Conclusions Identifying primary care patients with mild/moderate COPD suitable for ICS withdrawal is feasible but requires real-time verification because of unreliable recording of exacerbations and lung function. Suitable patients accepted randomisation to ICS withdrawal or continuation for the purposes of future studies. Follow-up compliance was high. Nearly 50% of participants with a diagnosis of mild/moderate COPD demonstrated previously undocumented FEV1 variability during follow-up, mandating monitoring for at least 6 months following withdrawal to exclude undiagnosed asthma.https://bmjopenrespres.bmj.com/content/9/1/e001311.full |
| spellingShingle | Nicholas Hart Mike Thomas Patrick Murphy Gill Gilworth Christopher J Corrigan PATRICK T WHITE Timothy H Harries Withdrawal of inhaled corticosteroids from patients with COPD with mild or moderate airflow limitation in primary care: a feasibility randomised trial BMJ Open Respiratory Research |
| title | Withdrawal of inhaled corticosteroids from patients with COPD with mild or moderate airflow limitation in primary care: a feasibility randomised trial |
| title_full | Withdrawal of inhaled corticosteroids from patients with COPD with mild or moderate airflow limitation in primary care: a feasibility randomised trial |
| title_fullStr | Withdrawal of inhaled corticosteroids from patients with COPD with mild or moderate airflow limitation in primary care: a feasibility randomised trial |
| title_full_unstemmed | Withdrawal of inhaled corticosteroids from patients with COPD with mild or moderate airflow limitation in primary care: a feasibility randomised trial |
| title_short | Withdrawal of inhaled corticosteroids from patients with COPD with mild or moderate airflow limitation in primary care: a feasibility randomised trial |
| title_sort | withdrawal of inhaled corticosteroids from patients with copd with mild or moderate airflow limitation in primary care a feasibility randomised trial |
| url | https://bmjopenrespres.bmj.com/content/9/1/e001311.full |
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