Part I | Part II | |||||||
---|---|---|---|---|---|---|---|---|
BUD800+EF | BUD800+PL | BUD400+EF | BUD400+PL | |||||
Run in | Change to 4 weeks | Run in | Change to 4 weeks | Baseline (week 4) | Change to 6 months | Baseline (week 4) | Change to 6 months | |
*p=0.0001 within treatment change from baseline; †p<0.01 within treatment change from baseline; ‡p=0.0001 between treatment change from baseline; §=p<0.001 between treatment change from baseline; ¶p<0.01 between treatment change from baseline; **p<0.05 between treatment change from baseline. | ||||||||
Relief inhaler use: | ||||||||
Inhalations/day | 2.09 (1.42) | −1.18 (1.45)* | 2.01 (1.48) | −0.85 (1.26)*§ | 0.71 (0.86) | −0.17 (0.82)* | 0.74 (0.88) | +0.20 (1.08)‡ |
[0, 8.7] | [−8.7, 4.6] | [0, 9.0] | [−7.1, 2.6] | [0, 4.3] | [−3.0, 3.0] | [0, 4.7] | [−2.9, 5.7] | |
Inhalations/night | 0.69 (0.75) | −0.38 (0.73)* | 0.75 (0.86) | −0.26 (0.75)* ** | 0.23 (0.45) | −0.001 (0.37) | 0.23 (0.47) | +0.18 (0.51)*‡ |
[0, 3.1] | [−2.6, 2.7] | [0, 4.1] | [−3.4, 2.0] | [0, 2.3] | [−1.6, 1.1] | [0, 3.9] | [−1.0, 3.1] | |
Symptom score: | ||||||||
Daytime | 1.23 (0.53) | −0.50 (0.60)* | 1.20 (0.56) | −0.35 (0.61)*¶ | 0.64 (0.57) | −0.16 (0.54)* | 0.64 (0.60) | +0.01 (0.54)‡ |
[0, 3.0] | [−2.1, 1.4] | [0, 3.0] | [−2.4, 1.4] | [0, 2.7] | [−2.0, 2.0] | [0, 3.0] | [−1.4, 1.7] | |
Night time | 0.91 (0.66) | −0.38 (0.66)* | 0.90 (0.65) | −0.28 (0.65)* | 0.39 (0.49) | −0.05 (0.43)† | 0.46 (0.58) | +0.03 (0.49)¶ |
[0, 3.0] | [−2.4, 1.4] | [0, 3.0] | [−2.1, 2.3] | [0, 2.6] | [−1.6, 1.6] | [0, 3.0] | [−1.4, 1.9] | |
Sleep disturbance: | ||||||||
Nights/week | 1.70 (2.26) | −1.01 (2.15)* | 1.59 (2.14) | −0.58 (2.16)* ** | 0.29 (1.06) | −0.01 (1.09) | 0.47 (1.39) | +0.05 (1.35) |
[0, 7] | [−7, 6] | [0, 7] | [−7, 7] | [0, 7] | [−7, 7] | [0, 7] | [−7, 7] |