NCT00846911已完成不适用
AVANTI - Avelox® in Acute Exacerbations of Chronic Bronchitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 2,672
- 主要终点
- Time until improvement of acute exacerbation
研究概览
简要总结
The objective of this global non-interventional study is to evaluate the impact of Acute Exacerbation of Chronic Bronchitis(AECB) on the patient and the community as well as the safety and effect of a treatment with Moxifloxacin tablets in daily life clinical practice. This includes data on the course of symptom relief, speed of return to normal daily life activities as well as records on adverse events.
This study will be performed in accordance with international guidelines like EMEA (EMEA, EUDRALEX Volume 9A, Pharmacovigilance for Medicinal Products for Human Use) as well as local laws.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at least 35 years of age with a diagnosis of Acute Exacerbation of Chronic Bronchitis (AECB) and decision taken by the investigator to treat with Avelox.
排除标准
- •Exclusion criteria must be read in conjunction with the local product information.
研究组 & 干预措施
Group 1
干预措施: Moxifloxacin (Avelox, BAY12-8039) (Drug)
结局指标
主要结局
Time until improvement of acute exacerbation
时间窗: End of study
次要结局
- Time until cure of acute exacerbation(End of study)
- Severity of AECB according to Antonisen criteria(Baseline)
- Impact of AECB on daily life activities(Baseline)
- Safety of Avelox under daily life treatment conditions(Throughout treatment)
研究者
相似试验
已完成
不适用
VICTOR - Avelox® Intravenous (i.v.) in Acute Exacerbations of Chronic BronchitisDisease ExacerbationChronic BronchitisNCT00876577Bayer1,206
已完成
不适用
Avelox in Complicated Skin and Skin Structure InfectionsSkin Diseases, BacterialNCT00997997Bayer6,127
已完成
3 期
BAY12-8039: 5 Days for Sinusitis vs PlaceboSinusitisNCT00492024Bayer374
已完成
不适用
Prospective observational study of acute exacerbation in interstitial lung diseases for new diagnostic criteriaacute deterioration of interstitial lung diseasesJPRN-UMIN000027844ational Hospital Organization Kinki-Chuo Chest Medical Center416
已完成
不适用
Prospective observational study of acute exacerbation of chronic fibrosing interstitial pneumoniaAcute exacerbation of chronic fibrosing interstitial pneumoniaJPRN-UMIN000022821Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital80