Zabofloxacin versus moxifloxacin in patients with COPD exacerbation: a multicenter, double-blind, double-dummy, randomized, controlled, Phase III, non-inferiority trial

被引:37
作者
Rhee, Chin Kook [1 ]
Chang, Jung Hyun [2 ]
Choi, Eu Gene [3 ]
Kim, Hyun Kuk [4 ]
Kwon, Yong-Soo [5 ]
Kyung, Sun Young [6 ]
Lee, Ji-Hyun [7 ]
Park, Myung Jae [8 ]
Yoo, Kwang Ha [9 ]
Oh, Yeon Mok [10 ]
机构
[1] Catholic Univ Korea, Seoul St Marys Hosp, Div Pulm Allergy & Crit Care Med, Dept Internal Med,Coll Med, Seoul, South Korea
[2] Ewha Womans Univ, Sch Med, Div Pulm & Crit Care Med, Dept Internal Med,Med Ctr, Seoul, South Korea
[3] Daejeon Hankook Hosp, Dept Internal Med, Div Pulm Allergy & Crit Care Med, Daejeon, South Korea
[4] Inje Univ, Coll Med, Div Pulm & Crit Care Med, Dept Internal Med,Haeundae Paik Hosp, Busan, South Korea
[5] Chonnam Natl Univ Hosp, Dept Internal Med, Div Pulm & Crit Care Med, Gwangju, South Korea
[6] Gachon Univ, Gil Med Ctr, Div Pulm Allergy & Crit Care Med, Dept Internal Med, Inchon, South Korea
[7] CHA Univ, CHA Bundang Med Ctr, Dept Internal Med, Div Pulm Allergy & Crit Care Med, Songnam, South Korea
[8] KyungHee Univ Hosp, Div Pulm & Crit Care Med, Dept Internal Med, Seoul, South Korea
[9] Konkuk Univ, Sch Med, Div Pulm Allergy & Crit Care Med, Dept Internal Med, Seoul, South Korea
[10] Univ Ulsan, Coll Med, Asan Med Ctr, Dept Pulm & Crit Care Med, Seoul 138736, South Korea
来源
INTERNATIONAL JOURNAL OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 2015年 / 10卷
关键词
chronic obstructive pulmonary disease; exacerbation; zabofloxacin; quinolone; EXACT-PRO; CAT; ACUTE BACTERIAL EXACERBATIONS; COURSE 5-DAY MOXIFLOXACIN; CHRONIC-BRONCHITIS; IN-VITRO; EFFICACY; DW-224A; SAFETY; THERAPY; FLUOROQUINOLONE; LEVOFLOXACIN;
D O I
10.2147/COPD.S90948
中图分类号
R56 [呼吸系及胸部疾病];
学科分类号
摘要
A new quinolone, zabofloxacin, has now been developed; hence, a non-inferiority trial is needed to compare this new compound with another widely used quinolone to examine its efficacy and safety for the treatment of chronic obstructive pulmonary disease (COPD) exacerbations. This was a prospective, multicenter, double-blind, double-dummy, randomized, controlled, parallel-group, Phase III, non-inferiority clinical trial designed to compare oral zabofloxacin (367 mg once daily for 5 days) with moxifloxacin (400 mg once daily for 7 days) for the treatment of patients with COPD exacerbation. In all, 345 COPD patients with a moderate COPD exacerbation were enrolled in the study via the outpatient clinics at 31 university hospitals. Clinical per protocol analysis revealed that the clinical cure rate for zabofloxacin was 86.7% and that for moxifloxacin was 86.3% (the rate difference, 0.4%; 95% confidence interval, -7.7%-8.6%). Intention-to-treat analysis revealed clinical cure rates of 77.1% and 77.3% (difference, -0.2%; 95% confidence interval, -9.0%-8.8%), respectively. These results confirm that zabofloxacin is not inferior to moxifloxacin. The favorable microbiological response rate for zabofloxacin was 67.4% and that for moxifloxacin was 79.5% (P=0.22). Patients in the zabofloxacin group showed better patient-oriented outcomes, as measured by EXAcerbations of Chronic Pulmonary Disease Tool-Patient-Reported Outcome and the COPD assessment test scores, than patients in the moxifloxacin group. Adverse drug reactions related to zabofloxacin occurred in 9.7% of cases and those related to moxifloxacin occurred in 9.6% of cases (P=0.97). The dropout rate due to adverse events was 0% (0/175) in the zabofloxacin group and 1.8% (3/167) in the moxifloxacin group (P=0.12). Oral zabofloxacin (367 mg once daily for 5 days) was not inferior to oral moxifloxacin (400 mg once daily for 7 days) for the treatment of patients with COPD exacerbation.
引用
收藏
页码:2265 / 2275
页数:11
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