Table 5.

Analysis of well-controlled asthma parameters over 52 weeks of treatment

Variable	Cic 160 μg/day	Cic 320 μg/day	Cic 640 μg/day	Change in ACQ score Cic 640 μg/day vs Cic 160 μg/day; Cic 320 μg/day vs Cic 160 μg/day; Cic 640 μg/day vs Cic 320 μg/day
				Hodges–Lehmann point estimate/HR*	95% CI	P-value
Number of weeks of well-controlled asthma, Wilcoxon–Mann–Whitney score**
Total	1211/5286 (22.9)	1514/5388 (28.1)	1447/5669 (25.5)	0.0	−3.0, 4.0	0.85
				1.0	−2.0, 5.0	0.42
				−1.0	−4.0, 3.0	0.69
ACQ cutoff point
0.5	719/5286 (13.6)	936/5388 (17.4)	944/5669 (16.7)	1.0	−1.0, 4.0	0.31
				0.0	−2.0, 4.0	0.71
				1.0	−2.0, 4.0	0.60
1	1726/5286 (32.7)	2182/5388 (40.5)	2026/5669 (35.7)	2.0	−1.0, 7.0	0.22
				4.0	0.0, 8.0	0.06
				−1.0	−5.0, 3.0	0.57
1.25	2003/5286 (37.9)	2468/5388 (45.8)	2327/5669 (41.0)	2.0	−1.0, 7.0	0.24
				4.0	−1.0, 9.0	0.10
				−1.0	−6.0, 3.0	0.64
1.5	2512/5286 (47.5)	2934/5388 (54.5)	2858/5669 (50.4)	2.0	−2.0, 6.0	0.33
				3.0	−1.0, 7.0	0.18
				−1.0	−5.0, 3.0	0.65
Number of patients with well-controlled asthma at study end, Fisher’s exact text#
Total	38 (31.7)	45 (36.9)	51 (40.8)	–	–	0.15
						0.42
						0.60
Time to first well-controlled asthma measurement, log−rank test#
Total	73 (60.8)	84 (68.9)	81 (64.8)	1.0	0.9, 1.2	0.61
				1.2	0.9, 1.6	0.25
				0.9	0.7, 1.2	0.49

Notes:

^*Hodges–Lehmann point estimate for Wilcoxon–Mann–Whitney, HR for log-rank test.

^**Data are n/n′ (%), where n represents the number of weeks with well-controlled asthma under study treatment across all patients, n′ represents the total number of weeks under study treatment across all patients.

^#Data are n (%) and represent the number of patients who were responders, defined as a patient with ACQ improvement of at least 0.5 at the end of the study, and the percentage of the population exposed who were responders.

Abbreviations: ACQ, Asthma Control Questionnaire; CI, confidence interval; Cic, ciclesonide; HR, hazard ratio.