Double-dummy method

The current randomised, double-blind, double-dummy, parallel-group, 12-month multicentre study evaluated the effect of budesonide/formoterol pressurised metred-dose inhaler (pMDI) on COPD exacerbations [6 ]. The method follows a 2-week nm-in during which COPD patients aged >40 years with an exacerbation history discontinued medications except inhaled corticosteroids 1219 patients were randomised 1 1 1 to twice-daily budesonide/formoterol pMDl 320/9 Jig, budesonide/formoterol pMDI 160/9 jig, or formoterol dry powder inhaler 9 jig. An exacerbation was defined as COPD worsening requiring oral corticosteroids and/or hospitalisation. 

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