Table 2 TDI focal score, and SGRQ and E-RS total scores (ITT population)
From: Efficacy and safety of CHF6001, a novel inhaled PDE4 inhibitor in COPD: the PIONEER study
CHF6001 | Budesonide 800 μg (N = 187) | Placebo (N = 193) | ||||
|---|---|---|---|---|---|---|
400 μg BID (N = 190) | 800 μg BID (N = 179) | 1200 μg BID (N = 188) | 1600 μg BID (N = 193) | |||
TDI focal score | ||||||
Week 12 | 1.23 (0.88, 1.57) | 1.21 (0.84, 1.57) | 1.15 (0.80, 1.50) | 0.99 (0.64, 1.34) | 1.03 (0.68, 1.37) | 1.21 (0.86, 1.56) |
Treatment–placebo difference | 0.02 (−0.48, 0.51) | −0.00 (−0.51, 0.50) | −0.06 (−0.55, 0.44) | −0.22 (−0.72, 0.28) | −0.18 (−0.68, 0.31) | |
Week 24 | 1.54 (1.19, 1.90) | 1.28 (0.90, 1.65) | 1.49 (1.13, 1.85) | 1.44 (1.08, 1.81) | 1.49 (1.13, 1.84) | 1.46 (1.11, 1.82) |
Treatment–placebo difference | 0.08 (−0.42, 0.58) | −0.19 (−0.70, 0.33) | 0.03 (−0.48, 0.53) | −0.02 (−0.53, 0.49) | 0.02 (−0.48, 0.53) | |
SGRQ total score, change from baseline | ||||||
Week 12 | −4.53 (−6.43, −2.62) | −6.62 (−8.57, −4.66) | −4.58 (−6.47, −2.69) | −6.38 (−8.26, −4.50) | −5.56 (−7.45, −3.67) | −6.17 (−8.06, −4.29) |
Treatment–placebo difference | 1.65 (−1.03, 4.33) | −0.44 (−3.15, 2.27) | 1.59 (−1.07, 4.26) | −0.21 (−2.87, 2.46) | 0.62 (−2.05, 3.28) | |
Week 24 | −5.54 (−7.64, −3.43) | −8.06 (−10.24, −5.89) | −5.95 (−8.04, −3.86) | −6.96 (−9.06, −4.87) | −7.11 (−9.20, −5.02) | −7.48 (−9.57, −5.40) |
Treatment–placebo difference | 1.95 (−1.02, 4.91) | −0.58 (−3.59, 2.43) | 1.54 (−1.42, 4.49) | 0.52 (−2.43, 3.47) | 0.38 (−2.58, 3.33) | |
E-RS total score, change from baseline | ||||||
Overall | −1.53 (−2.12, −0.94) | −2.41 (−3.01, −1.80) | −1.89 (−2.48, −1.31) | −2.07 (−2.66, −1.48) | −2.35 (−2.94, −1.76) | −2.21 (−2.79, −1.63) |
Treatment–placebo difference | 0.68 (−0.14, 1.50) | −0.20 (−1.03, 0.64) | 0.32 (−0.51, 1.14) | 0.14 (−0.68, 0.97) | −0.14 (−0.97, 0.68) | |