Figures & data
Figure 1 Disposition of patients during study.
Notes:
1Clinical ITT set: This population consisted of all randomized subjects who received at least one dose of the investigational product. 2Clinical PP set: This population consisted of all randomized subjects who met the study inclusion and/or exclusion criteria, who received an adequate course of therapy, for whom sufficient information was available to determine the subject’s outcome, and who had no confounding factors that interfered with the assessment of the outcome. 3Microbiological PP set: This population consisted of a subset of the clinical PP subjects who had a baseline pathogen identified.
Abbreviations: ZBO, zabofloxacin; MOX, moxifloxacin; ITT, intention-to-treat; PP, per protocol.
Abbreviations: ZBO, zabofloxacin; MOX, moxifloxacin; ITT, intention-to-treat; PP, per protocol.
Table 1 Baseline characteristics of the patients
Table 2 Clinical response rates
Table 3 Antimicrobial susceptibility of pathogens isolated at visit 1 (enrollment day)
Table 4 Microbiological response according to the microbiological per protocol analysis
Figure 2 Clinical per protocol analysis of changes in the EXACT-PRO and CAT scores.
Notes: The EXACT-PRO (A) and CAT scores (B) decreased significantly compared with those on D1 (*P<0.05, **P<0.01 vs D1) in both the zabofloxacin and moxifloxacin groups. The decline in the EXACT-PRO (C) scores on D6 and D7 and the decline in the CAT scores (D) on D5, D6, and D7 were significantly greater in the zabofloxacin than in the moxifloxacin group (*P<0.05 and **P<0.01 between the zabofloxacin and moxifloxacin groups).
Abbreviations: EXACT-PRO, EXAcerbations of Chronic Pulmonary Disease Tool-Patient-Reported Outcome; CAT, chronic obstructive pulmonary disease assessment test; D, day.
Abbreviations: EXACT-PRO, EXAcerbations of Chronic Pulmonary Disease Tool-Patient-Reported Outcome; CAT, chronic obstructive pulmonary disease assessment test; D, day.
Figure 3 Clinical intention-to-treat analysis of the changes of EXACT-PRO and CAT scores.
Notes: The EXACT-PRO (A) and CAT scores (B) decreased significantly compared with those on D1 (*P<0.05, **P<0.01 vs D1) in both the zabofloxacin and moxifloxacin groups. The decline in the EXACT-PRO (C) scores on D6 and D7 and the decline in the CAT scores (D) on D5, D6, D7, and D36 were significantly greater in the zabofloxacin than in the moxifloxacin group (*P<0.05 and **P<0.01 between the zabofloxacin and moxifloxacin groups).
Abbreviations: EXACT-PRO, EXAcerbations of Chronic Pulmonary Disease Tool-Patient-Reported Outcome; CAT, chronic obstructive pulmonary disease assessment test; D, day.
Abbreviations: EXACT-PRO, EXAcerbations of Chronic Pulmonary Disease Tool-Patient-Reported Outcome; CAT, chronic obstructive pulmonary disease assessment test; D, day.
Table 5 Adverse drug reactions