Table 1. Main characteristics of COPD studies with BDP/FF.

Name of the study	Treatments	Study duration	Rand. patients	Primary end points	Key inclusion criteria
NCT0047609920	BDP/FF (200/12 μg) BUD/FF (400/12 μg) FF (12 μg) BID	48 weeks	718	Change from baseline to 48 weeks in pre-dose FEV1 and mean rate of COPD exacerbations.	Age ⩾40 years ⩾20 pack-years PB FEV1 30%÷50% of pred. and FEV1/FVC<0.7 One severe exacerbation in the previous year Change in FEV1 <12% of pred. after salbutamol Free from COPD exacerbations for 12 weeks before randomisation
FORWARD28	BDP/FF (200/12 μg) FF (12 μg) BID	48 weeks	1199	Change from baseline to 12 weeks in pre-dose morning FEV1 and mean rate of COPD exacerbations	Age >40 years ⩾10 pack-years PB FEV1 30%÷50% of pred. and FEV1/FVC<0.7 Documented history of at least one exacerbation in the previous year
FUTURE37	BDP/FF (200/12 μg) FP/S (500/50 μg) BID	12 weeks	419	TDI score at week 12, and AUC0-30min at randomisation	Age ⩾ 40 years ⩾10 pack-years PB FEV1 30%÷60% of pred. and FEV1/FVC<0.7 BDI⩽10 An increase in FEV1 ⩾ 5% from baseline following administration of salbutamol

Abbreviations: AUC, area under the curve; BDI, baseline dyspnoea index; BID, bis in die; BDP, beclometasone; BUD, budesonide; FF, formoterol fumarate; FP, fluticasone; FVC, forced vital capacity; PB, postbronchodilator; pred., predicted; S, salmeterol, TDI, transitional dyspnoea index.