計劃書編號A0661147
試驗已結束
2005-12-01 - 2007-12-01
Phase III
終止收納4
ICD-10J44.0
慢性阻塞性肺病伴有急性下呼吸道感染
ICD-10J44.1
慢性阻塞性肺病伴有(急性)發作
ICD-9491.21
阻塞性慢性支氣管炎，併急性發作
ㄧ個第Ⅲb期,多中心,隨機,雙盲,比較性試驗以評估Azithromycin口服持效懸液劑(Azithromycin SR)與Moxifloxacin對於治療急性發作慢性支氣管炎的療效與安全性
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試驗委託 / 贊助單位名稱
N/A
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臨床試驗規模
多國多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
實際收案人數
0 終止收納
適應症
阻塞性慢性支氣管炎
試驗目的
試驗計劃名稱:ㄧ個第Ⅲb期,多中心,隨機,雙盲,比較性試驗以評估Azithromycin口服持效懸液劑(Azithromycin SR)與Moxifloxacin對於治療急性發作慢性支氣管炎的療效與安全性
主要目的：證明單一劑量2公克的Azithromycin口服持效懸浮液劑對於治療急性發作慢性支氣管炎的臨床療效，並不劣於連續口服Moxifloxacin 400公克5天
次要目的：比較上述二種治療方式其(1)細菌性療效、(2)第一次急性發作慢性支氣管炎的復發時間、(3)受試者健康的改善、(4)安全性與耐受性。
藥品名稱
膠囊劑
主成份
Azithromycin
劑型
130
劑量
2g
評估指標
Percentage of Clinical Cure (Success) at Test of Cure Visit(Clinical Per Protocol Population)
主要納入條件
Inclusion Criteria:
Diagnosis of chronic bronchitis (chronic cough and sputum production on most days for three consecutive months for more than two consecutive years) and clinical evidence of AECB as demonstrated by both the following symptoms:
Production of purulent sputum as defined by Gram stained sputum specimen
Presence of all of the following:
Increased sputum production
Increased dyspnea
Increased cough
At least two exacerbations of AECB in the past 12 months
Documented FEV1 less than 80% of predicted
Diagnosis of chronic bronchitis (chronic cough and sputum production on most days for three consecutive months for more than two consecutive years) and clinical evidence of AECB as demonstrated by both the following symptoms:
Production of purulent sputum as defined by Gram stained sputum specimen
Presence of all of the following:
Increased sputum production
Increased dyspnea
Increased cough
At least two exacerbations of AECB in the past 12 months
Documented FEV1 less than 80% of predicted
主要排除條件
Exclusion Criteria:
A chest radiograph consistent with pneumonia
Treatment with any systemic antibiotic within the twenty-one days prior to study entry or those with a chance of receiving other systemic antibiotics during study participation
A chest radiograph consistent with pneumonia
Treatment with any systemic antibiotic within the twenty-one days prior to study entry or those with a chance of receiving other systemic antibiotics during study participation
試驗計畫預計收納受試者人數
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台灣人數
30 人
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全球人數
416 人
