Effects of inhaled budesonide treatment on markers of airway inflammation and lung function
| Low dose budesonide study | High dose budesonide study | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Placebo | 100 μg budesonide | 400 μg budesonide | p value2-150 | Difference2-152 (Bud—Pla) | Difference2-152 (Pla—Bud) | p value (95% CI)2-160 | Placebo2-154 | 1600 μg budesonide2-154 | ||
| Δ FEV1 (l/min) | −0.2 (0.1) | 0.0 (0.1) | 0.5 (0.2) | 0.2 (0.0) | −0.4 (0.2) | <0.05 (0.1 to 0.9) | −0.1 (0.1) | 0.2 (0.1) | ||
| % change | −5.8 (2.4) | 1.2 (1.9) | 11.3 (4.3) | <0.052-151 | −2.8 (2.1) | 6.5 (3.2) | ||||
| Δ morning PEF (l/min) | −17 (10) | 20 (5) | 36 (14) | 26 (11) | −23 (16) | <0.05 (2 to 95) | −3.5 (9.9) | 26 (9) | ||
| % change | −2.9 (1.7) | 4.1 (1.2) | 7.3 (2.8) | <0.052-151 | −0.4 (2.0) | 5.9 (2.3) | ||||
| Δ PEF variability (%) | 5.7 (2.7) | −1.4 (1.3) | −4.7 (1.5) | <0.01 | −1.8 (3.5) | 1.3 (2.3) | NS | 0.0 (2.5) | −1.9 (1.7) | |
| Δ Symptom scores | 0.1 (0.5) | −0.4 (0.2) | −1.1 (0.2) | <0.05 | 0.0 (0.3) | 0.0 (0.6) | NS | 0.0 (0.1) | 0.1 (0.3) | |
| Δ Rescue inhaler (puff/day) | 0.6 (0.2) | −0.5 (0.3) | −0.9 (0.3) | <0.01 | −0.2 (0.2) | 0.1 (0.9) | NS | 0.2 (0.2) | 0.2 (0.3) | |
| Δ PC20(mg/ml)1 | −0.69 (2.00) | 1.01 (1.57) | 1.31 (1.51) | NS | 8.71 (1.54) | 0.16 (1.65) | <0.001 (0.003 to 0.089)2-153 | −0.68 (1.38) | 6.57 (1.50) | |
| Fold change in log PC20 | −0.3 (1.4) | 0.3 (1.3) | 0.3 (2.2) | −1.0 (0.8) | 2.8 (1.0) | |||||
| Δ Exhaled NO (ppb) | 1.5 (3.8) | −8.2 (2.7) | −19.2 (5.0) | −2.4 (6.4) | −22.5(6.3) | 0.07 (−50.2 to 2.2) | −3.5 (3.4) | −22.5(6.3) | ||
| Fold change | 0.1 (0.1) | −0.2 (0.1) | −0.6 (0.1) | <0.052-151 | 0.0 (0.1) | −0.5 (0.1) | ||||
| Δ Sputum eosinophil number (%)2 | 1.4 (9.2) | −3.5 (6.4) | −1.7 (5.4) | −0.2 (2.8) | 4.0 (4.9) | <0.05 (−8.1 to −2.0) | −0.5 (3.8) | −2.0 (7.6) | ||
| Fold change2 | 3.7 (5.1) | −0.6 (3.8) | −0.7 (0.6) | <0.052-151 | −0.3 (2.2) | −0.9 (0.4) | ||||
Abbreviations as in table 1.
Mean (SE) values are shown except 1geometric mean (geometric SE), 2median (interquartile range).
↵2-150 Significant difference between three treatment groups by one way ANOVA or Kruskal-Wallis test.
↵2-151 Percentage or fold changes from baselines were used for comparisons.
↵2-152 Differences between the values measured at the end of first treatment period (either budesonide or placebo) subtracted by the same values measured at the end of the second treatment period (either placebo or budesonide): each value indicates the average or median change from baseline in five subjects who received budesonide first followed by placebo (Bud—Pla) and vice versa (Pla—Bud).
↵2-160 Treatment effects obtained by comparing the differences between (Bud—Pla) and (Pla—Bud).
↵2-153 Geometric CI.
↵2-154 Summarises the changes from baseline in 10 subjects.