Table 2.
AUC of the SMS after 1, 2 and 3 years of preseasonal treatment
| Parameter | AUC of SMS | |||||
|---|---|---|---|---|---|---|
| FAS | PPS | FAS‐NE | ||||
| Active | Placebo | Active | Placebo | Active | Placebo | |
| DBPC (1 y of treatment) | ||||||
| n | 108 | 113 | 103 | 108 | 50 | 51 |
| Mean (SD) | 293.5 (168.1) | 298.3 (174.2) | 292.8 (166.0) | 301.3 (173.0) | 266.7 (146.5) | 313.8 (160.4) |
| Median | 291.5 | 261.0 | 286.0 | 263.0 | 261.3 | 271.0 |
| Min‐Max | 0.0‐651.0 | 11.0‐698.0 | 0.0‐651.0 | 11.0‐698.0 | 32.0‐540.0 | 57.0‐698.0 |
| Adjusteda LS‐mean (SE) | 311.5 (18.1) | 324.2 (17.6) | 309.3 (18.4) | 325.5 (17.8) | 286.5 (23.4) | 338.5 (22.1) |
| P‐value | 0.5755 | 0.4780 | 0.0733 | |||
| Active vs Placebo (% reduction) | 3.9 | 5.0 | 15.4 | |||
| DBPC (2 y of treatment) | ||||||
| n | 113 | 114 | 107 | 109 | 51 | 51 |
| Mean (SD) | 207.6 (173.8) | 238.9 (182.4) | 206.5 (172.9) | 239.3 (183.7) | 136.1 (115.6) | 205.7 (163.3) |
| Median | 155.0 | 213.0 | 155.0 | 216.0 | 104.0 | 174.0 |
| Min‐Max | 0.0‐633.0 | 0.0‐888.0 | 0.0‐633.0 | 0.0‐888.0 | 0.0‐485.0 | 0.0‐642.0 |
| Adjusteda LS‐mean (SE) | 227.1 (17.8) | 267.8 (17.4) | 222.4 (18.1) | 266.9 (17.8) | 160.8 (21.0) | 239.0 (20.0) |
| P‐value | 0.0710 | 0.0523 | 0.0034 | |||
| Active vs Placebo (% reduction) | 15.2 | 16.7 | 32.7 | |||
| DBPC + OLP (3 y of treatment) | ||||||
| n | 73 | n.d. | 69 | n.d. | 35 | n.d. |
| Mean (SD) | 128.5 (129.6) | n.d. | 130.5 (132.3) | n.d. | 106.0 (108.8) | n.d. |
| Median | 76.0 | n.d. | 76.0 | n.d. | 49.0 | n.d. |
| Min‐Max | 0.0‐492.0 | n.d. | 0.0‐492.0 | n.d. | 0.0‐382.0 | n.d. |
ANCOVA, analysis of covariance; AUC, area under the curve; DBPC, double‐blind placebo‐controlled; FAS, Full Analysis Set; FAS‐NE, FAS north‐east subgroup (patients of centres in Sweden, Finland, and Poland, excluding the most south‐western centre in Poland); LS, least‐squares; n, number of patients; n.d., no data; OLP, open‐label phase; PPS, Per Protocol Set; SD, standard deviation; SE, standard error; SMS, Symptom Medication Score.
a
ANCOVA model adjusted for asthma status at randomization and centre.