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Table 3 Differences in respiratory function parameters before and after administration of BUD/FORM or placebo and comparison of the change between treatment groups

From: Metabolic and cardiorespiratory effects of decreasing lung hyperinflation with budesonide/formoterol in COPD: a randomized, double-crossover, placebo-controlled, multicenter trial

Outcome, unit

LS mean change from pre-dose to post-dose

LS mean (95% CI)

treatment difference

P value*

BUD/FORM

Placebo

IC, L

0.256

− 0.024

0.280 (0.218 to 0.342)

<  0.001

FEV1, L

0.187

− 0.004

0.191 (0.150 to 0.233)

<  0.001

FVC, L

0.259

−0.052

0.312 (0.236 to 0.388)

<  0.001

FEV1/FVC

0.017

−0.002

0.019 (0.005 to 0.033)

0.007

VT, mL

71.90

14.28

57.62 (29.70 to 85.55)

<  0.001

VT/Ti, mL/sec

26.53

3.22

23.32 (3.72 to 42.91)

0.021

Ti/Ttot

0.012

−0.004

0.016 (−0.004 to 0.036)

0.113

RR, breaths/min

−0.19

−0.43

0.24 (− 0.44 to 0.91)

0.484

Ve (RR × VT), mL/min

838

−23.9

862 (440 to 1284)

<  0.001

MBSa

−0.45

−0.25

− 0.20 (− 0.45 to 0.05)

0.106

  1. BUD/FORM budesonide/formoterol, CI confidence interval, FEV1 forced expiratory volume in 1 s, FVC forced vital capacity, IC inspiratory capacity, LS least squares, MBS Modified Borg Dyspnea Scale, RR respiratory rate, Ti/Ttot respiratory time fraction, Ve minute ventilation, VT tidal volume, VT/Ti inspiratory flow rate
  2. aDyspnea was scored using the MBS, in which patients were asked to report their perception of breathing difficulty using a scale ranging from 0 (nothing at all) to 10 (extremely strong/maximal)
  3. *Bolded P values are statistically significant