Figures
- Fig. 1.—
Kaplan-Meier plot of discontinuations, by treatment group. ––: Symbicort; ·····: budesonide; ----: formoterol; –··–: placebo.
- Fig. 2.—
Mean values for forced expiratory volume in one second (FEV1) measured at clinic visits. ▪: budesonide/formoterol; ▴: budesonide; ▾: formoterol; ♦: placebo. p<0.001 budesonide/formoterol versus placebo and budesonide; p<0.001 formoterol versus placebo; p<0.05 budesonide versus placebo.
- Fig. 3.—
Change in morning peak expiratory flow (PEF) from baseline over 12 months (from daily diary card data). 1: budesonide/formoterol; 2: budesonide; 3: formoterol; 4: placebo. Differences of 16, 12, 24 L·min−1 for budesonide/formoterol versus budesonide, formoterol and placebo, respectively (all p<0.001); budesonide versus placebo 8 L·min−1 (p=0.015); formoterol versus placebo 12 L·min−1 (p<0.001).
- Fig. 4.—
Change in evening peak expiratory flow (PEF) from baseline over 12 months (from daily diary card data). 1: budesonide/formoterol; 2: budesonide; 3: formoterol; 4: placebo. Difference of 15, 11, 20 L·min−1 for budesonide/formoterol versus budesonide, formoterol and placebo, respectively (all p<0.001); budesonide versus placebo 5 L·min−1 (p=0.104); formoterol versus placebo 9 L·min−1 (p=0.009).
- Fig. 5.—
Improvements in morning peak expiratory flow (PEF) from daily diary card data (day 1 (┘) and week 1 (□)). Day 1: budesonide/formoterol versus budesonide p<0.001, versus formoterol p=0.081. Week 1: budesonide/formoterol versus budesonide p<0.001, versus formoterol p=0.002. *: p<0.05 versus placebo; ***: p<0.001 versus placebo.
Tables
- Table 1
Patient demographic and baseline characteristics
Budesonide/formoterol Budesonide Formoterol Placebo Patients n 208 198 201 205 Male % 76 80 76 83 Mean age yrs (range) 64 (41–82) 64 (40–90) 63 (40–90) 65 (47–92) Current smokers % 30 36 38 34 Mean pack-yrs 44 44 45 45 Previous medication % of patients ICS 26 24 28 26 Inhaled SABAs 67 70 71 69 Anticholinergics 24 31 27 29 Inhaled LABAs 17 17 16 20 Xanthines 26 25 22 31 Inhaled β2‐agonist/anticholinergic 25 20 20 21 FEV1 L 0.96 1.01 1.00 0.98 FEV1 % pred 36 37 36 36 FEV1/VC % 41 44 43 42 Reversibility % pred 6 5 6 5 -
ICS: inhaled corticosteroid
-
SABA: short-acting β2‐agonist
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LABA: long-acting β2‐agonist
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FEV1: forced expiratory volume in one second
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VC: vital capacity
-
% pred: % predicted normal
-
- Table 2
Patient flow
Budesonide/formoterol Budesonide Formoterol Placebo Total Patients randomised 208 198 201 205 812 Patients discontinued after randomisation# 59 (28)*** 62 (31)* 64 (32)* 90 (44) 275 Patients discontinued due to COPD deterioration# 20 (10)*** 23 (12)* 29 (14)* 43 (21) 115 Patients discontinued due to AEs other than COPD deterioration 16 (8) 13 (7) 12 (6) 17 (8) 58 Patients completing study 149 (72) 136 (69) 137 (68) 115 (56) 537 -
Data are presented as n (%) unless otherwise stated
-
*: p<0.05
-
***: p<0.001 versus placebo
-
#: Cox regression model
-
- Table 3
Statistical analysis of primary variables
Treatment comparisons Severe exacerbations FEV1 Reduction % (absolute values#) 95% CI p‐value Increase % 95% CI p‐value Budesonide/formoterol versus placebo 24 (0.758) 1.9–41.4 0.035 15 11.0–19.1 <0.001 Budesonide/formoterol versus budesonide 11 (0.889) −15.9–31.8 0.385 9 5.4–13.1 <0.001 Budesonide/formoterol versus formoterol 23 (0.771) 0.8–40.1 0.043 1 −2.2–4.9 0.487 Budesonide versus placebo 15 (0.852) −10.3–34.1 0.224 5 1.5–9.1 0.005 Formoterol versus placebo 2 (0.984) −25.7–23.0 0.895 14 9.5–17.7 <0.001 -
FEV1: forced expiratory volume in one second
-
CI: confidence interval
-
#: rate ratios (see Analysis section)
-
- Table 4
Symptom scores for first week of treatment and at 12 months
Treatment comparisons Total symptom score (0–16) Awakening score (0–4) Shortness of breath score (0–4) Cough score (0–4) Chest tightness score (0–4) Week 1 12 months Week 1 12 months Week 1 12 months Week 1 12 months Week 1 12 months Budesonide/ −1.21 −0.77 −0.30 −0.34 −0.35 −0.36 −0.28 −0.19 −0.24 −0.21 formoterol versus placebo (p<0.001) (p<0.001) (p<0.001) (p<0.001) (p<0.001) (p<0.001) (p<0.001) (p=0.002) (p<0.001) (p<0.001) Budesonide/ −0.80 −0.70 −0.20 −0.20 −0.28 −0.26 −0.15 −0.22 −0.14 −0.13 formoterol versus budesonide (p<0.001) (p<0.001) (p=0.004) (p=0.003) (p<0.001) (p<0.001) (p=0.022) (p<0.001) (p=0.020) (p=0.043) Budesonide/ −0.69 −0.27 −0.20 −0.16 −0.13 −0.11 −0.17 −0.08 −0.12 −0.03 formoterol versus formoterol (p<0.001) (p=0.103) (p=0.005) (p=0.019) (p=0.038) (p=0.107) (p=0.012) (p=0.204) (p=0.047) (p=0.678) -
Data are presented as score (p‐value)
-
- Table 5
Serious adverse events (SAEs)
Budesonide/formoterol Budesonide Formoterol Placebo Patients n 208 198 201 205 Deaths n 6 5 6 9 SAEs other than deaths n 43 35 37 37 SAEs per 1000 treatment days n 0.8 0.7 0.7 0.9 Patients with SAEs n (%) 46 (22) 35 (18) 39 (19) 42 (20)
German translation
Files in this Data Supplement:
Correction
Correction, published in Eur Respir J 2003; 21: 912.
Files in this Data Supplement:
- Correction - Correction, published in Eur Respir J 2003; 21: 912.
