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Table 2 Change from baseline in trough FEV1 (litres) (last observation carried forward) at week 8, by evening (PM) vs. morning (AM) FEV1 and treatment group (ITT population)

From: Efficacy in asthma of once-daily treatment with fluticasone furoate: a randomized, placebo-controlled trial

Week 8 PM FEV1

 

Placebo

(n = 101)

FF dose

  

200 mcg OD/PM

( n = 103)

400 mcg OD/PM

( n = 113)

200 mcg

BD

( n = 113)

Trough FEV1 (n)

77

92

103

100

   LS mean (SE)

2.198

(0.0458)

2.322

(0.0437)

2.438

(0.0398)

2.432

(0.0411)

   LS mean change (SE)

0.084

(0.0458)

0.208

(0.0437)

0.324

(0.0398)

0.319

(0.0411)

Difference from placebo

   Difference

 

0.124

0.240

0.235

   95% CI

 

0.010, 0.238

0.129, 0.351

0.123, 0.346

   p value

 

0.033

< 0.001

< 0.001

Week 8 AM FEV 1

 

Placebo

( n = 101)

FF dose

  

200 mcg OD/AM

( n = 105)

400 mcg OD/AM

( n = 111)

200 mcg

BD

( n = 113)

Trough FEV1 (n)

85

100

106

102

   LS mean (SE)

2.029 (0.0434)

2.203 (0.0389)

2.230 (0.0397)

2.344 (0.0400)

   LS mean change (SE)

0.053

(0.0434)

0.228

(0.0389)

0.255

(0.0397)

0.368

(0.040)

Difference from placebo

   Difference

 

0.174

0.202

0.315

   95% CI

 

0.067, 0.282

0.096, 0.307

0.208, 0.421

   p value

 

0.002

< 0.001

< 0.001

  1. BD = twice daily; CI = confidence interval; FEV1 = forced expiratory volume in one second; FF = fluticasone furoate; LS = least square; OD = once daily; SE = standard error