Withdrawal of high-dose inhaled corticosteroids in COPD patients with mild or moderate airflow limitation: a feasibility study in primary care

Background: High-dose inhaled corticosteroids (HD-ICS) are prescribed frequently outside guidelines in COPD, especially with mild or moderate airflow limitation. The acceptability and safety of withdrawal of HD-ICS in these patients is unknown. Aim: Feasibility study of a trial of the safe withdrawal of HD-ICS prescribed outside guidelines in COPD patients with mild or moderate airflow limitation. Method: COPD patients with mild or moderate airflow limitation using HD-ICS were invited to participate by their GPs. The challenges of identifying those suitable for inclusion have been described elsewhere. Participants were randomised to withdrawal from or continued use of HD-ICS. Impact of withdrawal was assessed through measures of lung function, quality of life, exacerbations, cellular and molecular biomarkers and neural respiratory drive. Measures were repeated at 3 and 6 months. Results: 61 patients attended. All agreed to undertake HD-ICS withdrawal. 21 patients were excluded due to: FEV1 reversibility (49%), severe airflow limitation (29%), no airflow obstruction (10%), frequent exacerbations in past year (4%), hospital admission for exacerbation (4%), BMI >35 (4%). 40 patients were recruited to the feasibility study. 20 were randomised to withdraw from HD-ICS use, 20 to continue HD-ICS use. Among the withdrawal arm, 5 resumed HD-ICS because of a decline in lung function or patient choice. Conclusions: A trial of the withdrawal of HD-ICS is feasible and acceptable to eligible patients responding to invitation. Of priority are identification of suitable patients and careful monitoring to detect a decline in lung function following withdrawal.