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Table 3 Asthma control days (%), rescue medication-free days (%), symptom-free days (%), and awakening-free nights (%): 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

Asthma control days (%)

n = 109

n = 114

n = 112

n = 105

 Baselinea, mean (SD)

12.8 (20.14)

14.3 (22.62)

11.5 (19.21)

10.0 (18.11)

 Week 12, mean (SD)

69.1 (37.69)

58.3 (42.02)

53.4 (40.11)

46.0 (41.22)

Change to week 12

    

 Mean (SD)

56.3 (39.11)

44.0 (39.49)

41.9 (42.13)

36.0 (39.27)

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

 p-value*

 

0.017†

0.117

0.012†

Rescue medication-free days (%)

n = 112

n = 116

n = 115

n = 109

 Baselinea, mean (SD)

21.8 (24.38)

21.4 (25.55)

19.5 (24.51)

17.2 (20.14)

 Week 12, mean (SD)

77.7 (32.12)

64.8 (39.49)

61.4 (37.19)

56.6 (39.95)

Change to week 12

    

 Mean (SD)

55.9 (36.43)

43.3 (37.69)

41.9 (39.49)

39.4 (38.69)

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

 p-value*

 

0.020†

0.125

0.012†

Symptom-free days (%)

n=110

n=114

n=115

n=108

 Baselinea, mean (SD)

28.0 (26.72)

28.6 (29.97)

22.6 (27.01)

22.7 (27.75)

 Week 12, mean (SD)

77.4 (35.21)

65.9 (38.59)

60.5 (38.67)

58.3 (38.99)

Change to week 12

    

 Mean (SD)

49.4 (38.17)

37.3 (39.79)

38.0 (42.64)

35.6 (42.18)

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

 p-value*

 

0.027†

0.195

0.151

Awakening-free nights (%)

n = 112

n = 116

n = 115

n = 108

 Baselinea, mean (SD)

59.1 (33.79)

62.1 (33.73)

62.9 (34.51)

56.3 (37.40)

 Week 12, mean (SD)

87.9 (26.73)

87.5 (26.77)

82.6 (31.57)

77.2 (34.17)

Change to week 12

    

 Mean (SD)

28.8 (33.91)

25.4 (35.92)

19.6 (35.68)

20.9 (41.05)

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

 p-value*

 

0.790

0.055

0.052

  1. b.i.d. = twice daily; N = total number of patients; n = number of patients in treatment group; FAS = full analysis set; SD = standard deviation.
  2. a. Baseline was the 7-day average calculated on the last 7 days prior to the first dose of study drug.
  3. b. Analysis method was Cochran-Mantel-Haenszel using van Elteren’s method for combining Wilcoxon rank sum test results from independent strata, with previous steroid use and site as the strata for the analysis.
  4. *All p values were exploratory.
  5. † p ≤ 0.050 versus fluticasone/formoterol 100/10 μg b.i.d. combination therapy but not statistically significant as per the sequential gatekeeping approach.
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BMC Pulmonary Medicine

ISSN: 1471-2466

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