Abstract
This thesis describes the results of the COPD study of the department of Pulmonary Medicine, Enschede (COPE study), the Netherlands. The main objective was to study whether a comprehensive self-management programme including self-treatment of exacerbations and a fitness programme is a clinically effective and economically efficient treatment option for moderate to severe COPD patients. Whilst designing the COPE self-management study, we took the opportunity also to assess additional important research questions: - Does optimisation of pulmonary status by appropriate up-to-date drug treatment, inhalation instructions and smoking cessation result in beneficial effects for COPD patients? - What is the effect of discontinuation of inhaled corticosteroids on exacerbations and Health-Related Quality of Life (HRQoL) in patients with COPD? - What is the role of bacterial colonisation in relation to Inhaled Corticosteroid (ICS) treatment and subsequent risk of exacerbations? - Which clinical factors can predict who needs treatment for antibiotics in exacerbations of COPD? The COPE study was designed as a combination of two sub studies. During the first substudy (discontinuation of inhaled corticosteroids study), the lung function of patients was optimised including a 4-month regimen of an inhaled corticosteroid (fluticasone propionate 500 (g twice daily), bronchodilation, and a smoking cessation programme for current smokers. All patients were instructed in the correct use of their inhaled medication. After these four months, patients were randomly assigned to continue fluticasone propionate or to receive placebo for 6 months. For the second substudy, all patients were subsequently randomised again into an intervention group receiving a comprehensive self-management programme and a control group receiving regular care from the chest physician only (the COPE self-management study). Patients attended the hospital every six months during a two-year follow-up period
