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Table 2 Comparisons between the groups at week 12: adjusted values from ANCOVA analysis

From: Extrafine Beclomethasone/formoterol compared to Fluticasone/salmeterol Combination Therapy in COPD

 

BDP/FF

FP/S

Between groups p value

 

(N = 211)

(N = 207)

 

Pre-dose morning FEV1, litre

0.08 (0.04 to 0.11)

0.06 (0.03 to 0.10)

0.58

Pre-dose morning FVC, litre

0.06 (-0.00 to 0.13)

0.05 (-0.01 to 0.12)

0.82

SGRQ score

-5.92 (-7.75 to -4.08)

-3.80 (-5.70 to -1.90)

0.08

SGRQ decrease from baseline > 4, patients (%)

95 (45.0)

75 (36.2)

0.16

6MWTa, meters

31.62 (15.18 to 48.06)

22.23 (6.30 to 38.16)

0.33

6MWT changea > 37 meters, patients (%)

39 (18.8)

34 (16.4)

0.60

Symptom scoreb

-1.21 (-1.55 to -0.87)

-1.00 (-1.35 to -0.65)

0.36

Breathlessness on risingb

-0.26 (-0.35 to -0.18)

-0.24 (-0.32 to -0.16)

0.65

Symptom-free daysc,%

4.60 (1.79 to 7.41)

5.88 (2.99 to 8.76)

0.50

Use of rescue medicationb, puffs

-0.60 (-0.78 to -0.42)

-0.63 (-0.81 to -0.45)

0.80

Rescue medication-free daysc,%

13.50 (9.39 to 17.61)

13.11 (8.89 to 17.32)

0.89

  1. All values are presented as mean (95% CI) or absolute number (%).
  2. BDP/FF, beclomethasone dipropionate/formoterol fumarate; FP/S, fluticasone propionate/salmeterol; FEV1, forced expiratory volume in the first second; FVC, Forced Vital Capacity; SGRQ, St. George’s respiratory questionnaire 6MWT, 6 minutes walking test.
  3. achange from pre-dose at randomization visit to pre-dose at the end of treatment.
  4. bmean of the last two weeks (week 11–12).
  5. coverall results were considered (entire treatment period).