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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).