Of the 7,241 patients that entered the study, 7,165 were available for analysis, of whom 3,597 were randomized to budesonide and 3,568 to placebo. From this cohort, 2,010 patients did not complete the 3 years of double-blind treatment. The dropout rate (27.5% in the budesonide group and 28.6% in the placebo group) and the mean time in the study (2.47 years in the budesonide group and 2.44 years in the placebo group) were comparable for the two treatment arms. There were 3,419 patients in the budesonide group and 3,394 patients in the placebo group with assessments of postbronchodilator FEV1 at baseline and on at least one follow-up occasion. All these patients are used in the longitudinal analysis of postbronchodilator FEV1. The baseline characteristics were similar in the two treatment groups (Table 1).
The mean baseline prebronchodilator FEV1 percentage of predicted for the whole cohort was 86.5% (SD 13.9%), with the mean postbronchodilator FEV1 improving to 96.3% (SD 13.2%). The baseline FEV1 values were similar in both genders and across all age groups. The mean baseline prebronchodilator FEV1 of current or previous smokers was not different from nonsmokers; however, the postbronchodilator FEV1 values were slightly reduced to 95.7% when compared to the nonsmoker values of 96.9%. storehealthmall.eu
Treatment with budesonide significantly improved both prebronchodilator and postbronchodilator FEV1 percentage of predicted (Fig 1). These differences were obvious by 6 weeks, when the changes from baseline in postbronchodilator FEV1 were + 0.27% in the budesonide group and – 1.65% in the placebo group (p < 0.001). Over 3 years, the postbronchodilator FEV1 declined significantly in both groups, but a significant treatment effect for budesonide persisted. After 3 years, the postbronchodilator FEV1 values were – 1.79% in the budesonide group and – 2.68% in the placebo group (p < 0.001). The mean difference in postbronchodilator FEV1 between budesonide and placebo was 0.88% (p < 0.001). The mean baseline postbronchodilator FVC percentage of predicted in the adult patients was 97.2% (SD 13.6%), with the FEV1/FVC ratio being 85.2% (SD 8.2%). Over 3 years, the FEV1/FVC ratio declined significantly (p < 0.001) in both treatment groups by 1.74% in the placebo group and by 0.58% in the budesonide group. The magnitude of the change in the budesonide group was significantly less than that in the placebo group (p < 0.001).
Table 1—Baseline Patient Characteristics
| Characteristics | Budesonide (n = 3,597) | Placebo (n = 3,568) |
| Age, yr | ||
| 5-10 | 27.8 | 27.3 |
| 11-17 | 17.8 | 16.3 |
| 18-66 | 54.4 | 56.4 |
| Ethnic origin | ||
| White | 65.4 | 64.7 |
| Black | 1.4 | 1.7 |
| Oriental | 27.7 | 27.9 |
| Other | 5.5 | 5.6 |
| Gender | ||
| Male | 45.8 | 46.0 |
| Female | 54.2 | 54.0 |
| Duration of asthma prior to entry | ||
| < 3 mo | 36.8 | 35.7 |
| 3 mo to < 6 mo | 14.4 | 13.3 |
| 6 mo to < 1 yr | 15.5 | 16.9 |
| a 1 yr | 33.3 | 34.1 |
| Number of symptomatic days in past 2 weeks | ||
| None | 8.6 | 8.8 |
| 1-3 d | 36.3 | 34.6 |
| 4-7 d | 33.5 | 35.8 |
| > 7 d | 21.6 | 20.8 |
| Smoking status | ||
| Current or previous smoker | 20.5 | 20.3 |
| Passive smoker | 28.0 | 30.1 |
| None | 51.5 | 49.6 |
| Prebronchodilator FEV1 % | 86.3 (13.9) | 86.6 (13.9) |
| of predicted | ||
| Postbronchodilator FEV1 % | 96.2 (13.1) | 96.4 (13.3) |
| of predicted | ||
Figure 1. Effects of treatment with inhaled budesonide or placebo on change from baseline in prebronchodilator and postbronchodilator FEV1 percentage of predicted over 3 years. Points and error bars show means and 95% confidence intervals for each follow-up visit. Curves show the estimated time-re-sponse from a longitudinal analysis. Solid symbols and solid lines denote budesonide. Open symbols and dashed lines denote placebo. Budesonide significantly improved both prebronchodilator and postbronchodilator FEV1 percentage of predicted.