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Table 4 Use of rescue medication (number of inhalations/day), asthma symptom scores, and sleep disturbance scores: mean change from baseline to week 12, 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

Characteristic

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

Rescue medication use (inhalations/day)

n = 112

n = 116

n = 115

n = 109

 Baselinea, mean (SD)

2.8 (2.05)

3.0 (2.24)

3.0 (2.07)

3.0 (1.68)

Change to week 12

    

 Mean (SE)b

−2.22 (0.165)

−1.64 (0.160)

−1.62 (0.163)

−1.16 (0.162)

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

 LS Mean (SE)

 

−0.58 (0.217)

−0.60 (0.218)

−1.06 (0.222)

 95% CI

 

−1.01, -0.15

−1.03, -0.17

−1.50, -0.63

 p-value*

 

0.008**

0.006**

<0.001**

Asthma symptom scores

n = 110

n = 114

n = 115

n = 108

 Baselinea, mean (SD)

1.0 (0.60)

1.0 (0.64)

1.1 (0.61)

1.1 (0.62)

Change to week 12

    

 LS Mean (SE)b

−0.72 (0.060)

−0.59 (0.058)

−0.54 (0.059)

−0.51 (0.059)

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

 LS Mean (SE)

 

−0.13 (0.079)

−0.18 (0.079)

−0.21 (0.081)

 95% CI

 

−0.29, 0.03

−0.33, -0.02

−0.37, -0.05

 p-value*

 

0.100

0.027†

0.011**

Sleep disturbance scores

n = 112

n = 116

n = 115

n = 108

 Baselinea, mean (SD)

0.5 (0.54)

0.5 (0.45)

0.4 (0.49)

0.6 (0.57)

Change to week 12

    

 LS Mean (SE)b

−0.36 (0.033)

−0.34 (0.032)

−0.28 (0.033)

−0.27 (0.033)

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

 LS Mean (SE)

 

−0.02 (0.043)

−0.09 (0.044)

−0.10 (0.044)

 95% CI

 

−0.11, 0.07

−0.17, 0.00

−0.18, -0.01

p-value*

 

0.632

0.053

0.031†

  1. b.i.d. = twice daily; N = number of patients in treatment group; n = number of patients with data available; CI = confidence interval; FAS = full analysis set; LS = least squares; SD = standard deviation; SE = standard error.
  2. a. Baseline was the 7-day average calculated in the last 7 days prior to the first dose of study drug.
  3. b. LS mean, SE, CI and p-value are from ANCOVA with factors for treatment group, site, and prior steroid use, with baseline value as a continuous covariate.
  4. * All p-values were exploratory.
  5. ** p ≤ 0.050 versus fluticasone/formoterol 100/10 μg b.i.d. combination therapy and statistically significant as per the sequential gatekeeping approach.
  6. p ≤ 0.050 versus fluticasone/formoterol 100/10 μg b.i.d. combination therapy but not statistically significant as per the sequential gatekeeping approach.