Table 2.

TDI focal score, and SGRQ and E-RS total scores (ITT population)

	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)

Data are adjusted mean (95% CI). There were no statistically significant treatment–placebo or CHF6001–budesonide differences. TDI Transition Dyspnea Index, SGRQ St George’s Respiratory Questionnaire, E-RS Exacerbations of Chronic Pulmonary Disease Tool – Respiratory Symptoms, ITT intention-to-treat, BID twice daily