Table 1 Main characteristics of COPD studies with BDP/FF

From: Extrafine beclometasone diproprionate/formoterol fumarate: a review of its effects in chronic obstructive pulmonary disease

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

  1. 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.
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