Withdrawal of Inhaled Corticosteroids from COPD Patients with Mild or Moderate Airflow Limitation: Primary Care Feasibility Randomised Controlled Trial Reveals High Prevalence of Suspected Undiagnosed Asthma

Abstract BackgroundInhaled corticosteroids (ICS) are frequently prescribedoutsideguidelines to COPD patients with mild or moderate airflow limitation and low exacerbation risk, despite little evidence of benefit and risk of adverse effects. This trial explored thefeasibilityof ICS withdrawalfrompatients with mild/moderate COPD in primary care.MethodsOpen, feasibility trial. Outcome measures included prevalence of suitable participants, sensitivity and specificity of their identification,their willingness to accept open randomisation to ICS withdrawal for up to 6 months or continuation with usual care.Results392 (13%) of 2967COPD patients from 20 practices (209,618 total population)identifiedas eligible for ICS withdrawalby algorithm electronic record search.Following individual record review, 243 (62%)deemedineligible because of (a)one severeor two moderate COPD exacerbations in previous year (86, 22%); (b)severe airflow limitation (65, 17%); (c) asthma (15, 4%); (d)other causes (77, 20%). Remainder (149)invited for assessment.61 attended and all agreed to randomisation to ICS withdrawal or usual care. At baseline assessment, 10 exhibitedairflow reversibility (forced expiratory volume (FEV)1 reversibility>12% and 200ml) which was a safety exclusion criterion, 2 had suffered ≥2 moderate exacerbations in prior year,7 had severe airflow limitation,2 had normal spirometry.40 were randomised.During ensuing 6 months, 1 patient died and another was lost to follow-up. 18 (45%) of the 38 (10 withdrawal, 8 usual care) exhibited previously undocumented FEV1variability consistent with asthma,supported bysignificant associations in ICS withdrawal group between FEV1 variability andelevated fractional exhaled nitric oxide (p=0.04), atopic history (p=0.01), elevated symptom score (p=0.04),poorerquality of life (p=0.04).ConclusionIdentifyingpatients with mild/moderate COPD suitable for ICS withdrawal was difficult because of poor recording of suitability criteria (undocumented exacerbations, unreliable lung function). Open, randomisation to ICS withdrawal or usual care was acceptableFollow-upretention at 6 months was excellent.Nearly 50% of participants with mild/moderate COPD and no previously recorded bronchodilator reversibility, demonstrated FEV1 variability during follow-up. In patients with mild/moderate COPD considered suitable for ICS withdrawal in primary care, surveillance of variability should be undertaken over at least 6 months. Trial registrationEudraCT Number: 2016-001876-31. Date registered: 5th August 2016.