The change in postbronchodilator FEV1 in the treatment groups demonstrated a Gaussian-like distribution (Fig 2), and the decline was more marked for males, current, or previous smokers, and patients > 18 years old. In the placebo group over years, the decline in male subjects was — 3.6% and in female subjects was — 1.95%; while in the budesonide group, the decline in male patients was — 2.68% and in female patients was — 1.13%. Similarly, in active smokers in the placebo group, the decline over 3 years was — 4.36% and in nonsmokers was — 2.45%, while in the budesonide group the decline in active smokers was — 2.84% and in nonsmokers was — 1.53%. mycanadianfamilypharmacy.net
Interestingly, the smallest decline in postbronchodilator FEV1 over 3 years was seen in adolescents when compared to children or adults (Fig 3): change from baseline in the placebo group, — 0.39%; change from baseline in the budesonide group, — 0.91%. In addition, the smallest treatment effect of budesonide on postbronchodilator FEV1 was seen in adolescents.
The prebronchodilator FEV1 increased in both treatment groups but significantly more in the budesonide-treated group (p < 0.001 for all time points), especially after 1 year of treatment. The proportion of patients with a prebronchodilator FEV1 < 80% of predicted at baseline or having received a dose of corticosteroids during the preceding 6 weeks was 40%. For these patients, the 3-year change from baseline in postbronchodilator FEV1 percentage of predicted was — 0.02% in the budesonide group and -1.43% in the placebo group (p = 0.003). The bronchodilator responses measured at baseline demonstrated a 9.9% improvement in FEV1 for the entire population. At 1 year, the improvement in FEV1 was 4.8% in the budesonide group and 5.8% in the placebo group (mean difference, — 0.97%; p < 0.001). This difference was maintained at 2 years and 3 years: — 0.81% and — 1.04% respectively (each p < 0.001).
Figure 2. Interlaced histograms of change over 3 years in postbronchodilator FEV1 percentage of predicted for the two treatment groups. The bar width represents 5%. The budesonide group is represented by solid bars, and the placebo group is represented by open bars. The difference between budesonide and placebo is statistically significant (p < 0.001).
Figure 3. The change in postbronchodilator FEV1 percentage of predicted after 3 years of treatment with inhaled budesonide or placebo in children < 11 years old, in adolescents 11 to 17 years old, and in adults a 18 years old at time of randomization. A significant treatment effect in postbronchodilator FEV1 percentage of predicted was demonstrated in adults (p < 0.001) but not in adolescents (p = 0.38) or in children (p = 0.31).