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A Alsaeedi

A McGuire

A O'Brien

CP van Schayck

D Stanescu

EF Wouters

GC Donaldson

J Vestbo

K Herland

L Davies

M Miravitlles

NA Jarad

NR Anthonisen

P Calverley

PL Paggiaro

PR Tirimanna

PS Burge

PW Jones

RA Pauwels

RE Kanner

S Spencer

TA Seemungal

TR Schermer

V van d

English

PubMed

Springer - Publisher Connector

Withdrawal of inhaled corticosteroids in people with COPD in primary care: a randomised controlled trial

Abstract Background Guidelines recommend inhaled corticosteroids (ICS) for patients with severe chronic obstructive pulmonary disease (COPD). Most COPD patients are managed in primary care and receive ICS long-term and irrespective of severity. The effect of withdrawing ICS from COPD patients in primary care is unknown. Methods In a pragmatic randomised, double-blind, placebo-controlled trial in 31 practices, 260 COPD patients stopped their usual ICS (median duration of use 8 years) and were allocated to 500 mcg fluticasone propionate twice daily (n = 128), or placebo (n = 132). Follow-up assessments took place at three monthly intervals for a year at the patients' practice. Our primary outcome was COPD exacerbation frequency. Secondary outcomes were time to first COPD exacerbation, reported symptoms, peak expiratory flow rate and reliever inhaler use, and lung function and health related quality of life. Results In patients randomised to placebo, COPD exacerbation risk over one year was RR: 1.11 (CI: 0.91–1.36). Patients taking placebo were more likely to return to their usual ICS following exacerbation, placebo: 61/128 (48%); fluticasone: 34/132 (26%), OR: 2.35 (CI: 1.38–4.05). Exacerbation risk whilst taking randomised treatment was significantly raised in the placebo group 1.48 (CI: 1.17–1.86). Patients taking placebo exacerbated earlier (median time to first exacerbation: placebo (days): 44 (CI: 29–59); fluticasone: 63 (CI: 53–74), log rank 3.81, P = 0.05) and reported increased wheeze. In a post-hoc analysis, patients with mild COPD taking placebo had increased exacerbation risk RR: 1.94 (CI: 1.20–3.14). Conclusion Withdrawal of long-term ICS in COPD patients in primary care increases risk of exacerbation shortens time to exacerbation and causes symptom deterioration. Patients with mild COPD may be at increased risk of exacerbation after withdrawal. Trial Registration ClinicalTrials.gov NCT00440687</p

Wedzicha Jadwiga A

James Wai-Yee

Eldridge Sandra

Kilvington Hazel E

Dawson Carolyn M

Choudhury Aklak B

Feder Gene S

Griffiths Chris J

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Respiratory Research

Crossref

Aklak B Choudhury

Carolyn M Dawson

Hazel E Kilvington

Sandra Eldridge

Wai-Yee James

Jadwiga A Wedzicha

Gene S Feder

Chris J Griffiths

The British Lung Foundation and Newham National Health Service Trust Research and Development funded the study

Choudhury, AB

Dawson, CM

Kilvington, HE

Eldridge, S

James, WY

Wedzicha, JA

Feder, GS

Griffiths, CJ

Queen Mary Research Online

Withdrawal of inhaled corticosteroids in people with COPD in primary care: A randomised controlled trial

a new facility for the measurement of healthrelated quality of life. The EuroQol Group. Health Policy

A: The excess cost of acute exacerbations of chronic bronchitis in patients aged 45 and older in England and Wales. Value Health

A: The IPCRG Guidelines: developing guidelines for managing chronic respiratory diseases in primary care. Prim Care Respir J

Airways obstruction, chronic expectoration, and rapid decline of FEV1 in smokers are associated with increased levels of sputum neutrophils. Thorax

Chronic obstructive pulmonary disease. National clinical guideline on management of chronic obstructive pulmonary disease in adults in primary and secondary care. Thorax

Combined salmeterol and fluticasone in the treatment of chronic obstructive pulmonary disease: a randomised controlled trial. Lancet

Effect of discontinuation of inhaled corticosteroids in patients with chronic obstructive pulmonary disease: the COPE study. Am J Respir Crit Care Med

FA: The effects of inhaled corticosteroids in chronic obstructive pulmonary disease: a systematic review of randomized placebo-controlled trials.

Hensing CA, Creutzberg EC: Withdrawal of fluticasone propionate from combined salmeterol/fluticasone treatment in patients with COPD causes immediate and sustained disease deterioration: a randomised controlled trial. Thorax

How representative are clinical study patients with asthma or COPD for a larger &quot;real life&quot; population of patients with obstructive lung disease? Respir Med

Littlejohns P: A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis

Lower respiratory illnesses promote FEV(1) decline in current smokers but not ex-smokers with mild chronic obstructive pulmonary disease: results from the lung health study. Am J Respir Crit Care Med

Multicentre randomised placebo-controlled trial of inhaled fluticasone propionate in patients with chronic obstructive pulmonary disease.

NA: Antibiotic therapy in exacerbations of chronic obstructive pulmonary disease. Ann Intern Med

PM: An observational study of inhaled corticosteroid withdrawal in stable chronic obstructive pulmonary disease. ISOLDE Study Group. Respir Med

PM: Oral corticosteroids in patients admitted to hospital with exacerbations of chronic obstructive pulmonary disease: a prospective randomised controlled trial. Lancet

Probability and determinants of relapse after discontinuation of inhaled corticosteroids in patients with COPD treated in general practice. Prim Care Respir J

Rounds S: Effects of withdrawal of inhaled steroids in men with severe irreversible airflow obstruction. Am J Respir Crit Care Med

SS: Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) Workshop summary. Am J Respir Crit Care Med

TK: Randomised, double blind, placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: the ISOLDE trial. BMJ

Vidal R: Effect of exacerbations on quality of life in patients with chronic obstructive pulmonary disease: a 2 year follow up study. Thorax

Viskum K: Longterm effect of inhaled budesonide in mild and moderate chronic obstructive pulmonary disease: a randomised controlled trial. Lancet

Wedzicha JA: Effect of exacerbation on quality of life in patients with chronic obstructive pulmonary disease.

Wedzicha JA: Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax

Wedzicha JA: Time course and recovery of exacerbations in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med

WJ: Prevalence of asthma and COPD in general practice in 1992: has it changed since 1977? Br J Gen Pract

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Withdrawal of inhaled corticosteroids in people with COPD in primary care: a randomised controlled trial

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