TABLE 2.
Outcomes for participants to doxophylline group and non‐doxophylline group, per‐protocol population.
| Parameters | Doxophylline group (n = 68) | Non‐doxophylline group (n = 87) | Rate ratio (95% CI) | P value |
|---|---|---|---|---|
| Number of moderate or severe exacerbations (n, %) | ||||
| 1 month | 5 (3.2%) | 6 (3.9%) | 1.0 (0.3–3.4) | 0.913 |
| 3 months | 17 (11.0%) | 24 (15.5%) | 0.9 (0.5–1.5) | 0.717 |
| 6 months | 6 (3.9%) | 23 (14.8%) | 0.3 (0.1–0.7) | 0.005 |
| Time of moderate or severe exacerbations (n, %) | ||||
| 1 month | 0.1 ± 0.3 | 0.1 ± 0.3 | 0.1 ± 0.3 | 0.913 |
| 3 months | 0.3 ± 0.4 | 0.3 ± 0.5 | 0.3 ± 0.4 | 0.718 |
| 6 months | 0.1 ± 0.4 | 0.3 ± 0.6 a | 0.2 ± 0.5 | 0.006 |
| Total time | 0.4 ± 0.5 | 0.7 ± 0.6 | 0.6 ± 0.6 | 0.215 |
| FEV1% predicted | 44.5 | 46.0 | 46.0 | 0.508 |
| MEF% | 33.0 | 34.0 | 34.0 | 0.634 |
| Leukocyte (10^9/L)‐6 months | 7.0 ± 2.6 | 7.5 ± 2.4 | 7.2 ± 2.5 | 0.143 |
| Neutrophil percentage (%)‐6 months | 62.2 | 65.8 a | 63.7 | 0.002 |
| Lymphocyte percentage (%)‐6 months | 21.1 | 23.4 | 21.9 | 0.375 |
| Eosinophil percentage (%)‐6 months | 1.5 | 2.3 | 1.8 | 0.063 |
| Adverse events rate (n, %) | 0.628 | |||
| Acid regurgitation | 2 (2.9%) | 0 (0.0%) | ||
| Palpitation | 3 (5.9%) | 0 (0.0%) |
a
There was a clinically significant difference between DG and NDG.