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Table 2 Mean change in FEV 1 (L) from pre-dose at baseline to pre-dose and 2-hour post-dose at week 12, (LOCF), time to discontinuation due to lack of efficacy and study duration for each treatment group, Full Analysis Set

From: Safety and efficacy of fluticasone/formoterol combination therapy in adolescent and adult patients with mild-to-moderate asthma: a randomised controlled trial

 

Treatment group

 

Fluticasone/formoterol 100/10 μg b.i.d. N = 115

Fluticasone 100 μg b.i.d. N = 117

Formoterol 10 μg b.i.d. N = 116

Placebo b.i.d. N = 111

Baseline FEV1 (L)

    

 Mean (SD)

2.416 (0.5790)

2.425 (0.6625)

2.459 (0.6231)

2.352 (0.6114)

Change in FEV1 from pre-dose at baseline to pre-dose at week 12

 LS Mean (SE)

0.195 (0.038)

0.092 (0.037)

0.094 (0.038)

0.047 (0.037)

Difference from fluticasone/formoterol 100/10 μg b.i.d.: contribution from fluticasone component

 LS Mean (SE)

 

0.103 (0.050)

0.101 (0.050)

0.147 (0.051)

 95% CI

 

0.005, 0.201

0.002, 0.199

0.048, 0.247

p-value

 

0.040

0.045

0.004

Change in FEV1 from pre-dose at baseline to 2 hours post-dose at week 12

 LS Mean (SE)

0.392 (0.035)

0.191 (0.034)

0.330 (0.035)

0.124 (0.035)

Difference from fluticasone/formoterol 100/10 μg b.i.d.: contribution from formoterol component

 LS Mean (SE)

 

0.200 (0.047)

0.062 (0.047)

0.267 (0.047)

 95% CI

 

0.109, 0.292

−0.030, 0.153

0.175, 0.360

p-value

 

< 0.001

0.187

< 0.001

Discontinuation due to lack of efficacy

 Number, %

7 (6.1)

9 (7.7)

13 (11.2)

18 (16.2)

Time to discontinuation, weeksa

 Mean

6.9

4.7

4.6

5.5

p-value b

0.015

   
  1. b.i.d. = twice daily; N = total number of patients; SD = standard deviation; LS = least squares; SE = standard error; NA = not applicable; CI = confidence interval; LOCF = last observation carried forward; FEV1 = Forced Expiratory Volume in the first second.
  2. a. Time to discontinuation due to lack of efficacy calculated as (Date of early discontinuation - Date of first study drug administration+1)/7 and rounded to 1 decimal place (based on all patients who discontinued).
  3. b. p-value based on stratified log-rank test adjusting for prior steroid use for fluticasone/formoterol 100/10 μg b.i.d. versus placebo.