Table 2.
Analysis | Intervention Group (N = 600) | Usual-Care Group (N = 601) | Between-Group Comparison (95% CI) | P Value |
---|---|---|---|---|
Primary analysis: severe asthma exacerbation | ||||
Total no. of exacerbations | 585 | 680 | ||
Adjusted annualized rate per participant (95% CI) | 0.69 (0.61–0.78) | 0.82 (0.73–0.92) | Hazard ratio: 0.85 (0.72–0.999) | 0.048 |
Secondary analyses | ||||
Asthma Control Test | ||||
Mean baseline score (95% CI) | 14.7 (14.4–15.1) | 14.5 (14.2–14.9) | ||
Overall mean postbaseline score (95% CI) | 18.0 (17.7–18.3) | 17.1 (16.7–17.4) | ||
Least-squares mean change from baseline (95% CI) | 3.4 (3.1–3.6) | 2.5 (2.3–2.8) | Difference: 0.9 (0.5–1.2) | |
Asthma Symptom Utility Index | ||||
Baseline mean score (95% CI) | 0.67 (0.65–0.69) | 0.67 (0.65–0.69) | ||
Overall mean postbaseline score (95% CI) | 0.79 (0.77–0.80) | 0.75 (0.74–0.76) | ||
Least-squares mean change from baseline (95% CI) | 0.12 (0.11–0.13) | 0.08 (0.07–0.09) | Difference: 0.04 (0.02–0.05) | |
Annualized no. of days missed from work, school, or usual activities (95% CI) | 13.4 (11.9–15.2) | 16.8 (14.9–18.9) | Rate ratio: 0.80 (0.67–0.95) | |
Post hoc analysis | ||||
Annualized no. of months with a reported asthma-related emergency department or urgent care visit (95% CI) | 0.75 (0.65–0.87) | 0.90 (0.77–1.04) | Rate ratio: 0.84 (0.68–1.03) | |
Safety analysis | ||||
No. of asthma-related hospitalizations | 70 | 84 | Rate ratio: 0.84 (0.50–1.42) |
Hazard ratio for the primary end point was adjusted for baseline characteristics and for a time-dependent covariate for the effects of coronavirus disease 2019. The widths of the confidence intervals for the secondary, post hoc, and safety analyses have not been adjusted for multiplicity and cannot be used to infer treatment effects.