計劃書編號A5641009
試驗已結束
2005-12-01 - 2006-12-01
Phase II
終止收納3
一項第二期、隨機、雙盲、安慰劑對照、平行組研究，評估UK-500,001乾粉吸入劑（DPI）在中度至重度慢性阻塞性肺疾病（COPD）成人患者中的療效與安全性
-
試驗委託 / 贊助單位名稱
N/A
-
臨床試驗規模
多國多中心
-
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
實際收案人數
0 終止收納
適應症
中度至重度慢性阻塞性肺疾。
試驗目的
第二期、隨機的、雙盲的、安慰劑控制的、平行分組的臨床試驗，用來評估UK-5200,001乾粉吸入劑，對中度至重度慢性阻塞性肺疾的成人患者之有效性及安全性。
藥品名稱
粉狀吸入劑
主成份
UK-500,001
劑型
105
劑量
0.1 mg/ 0.4 mg/ 1 mg
評估指標
Mean change from Baseline in trough (prior to administration of study drug) forced expiratory volume in 1 second (FEV1) at Week 6.
主要納入條件
Male or female subjects aged between 40 to 80 years, weighing >40 kg with body mass
index <35 kg/m2 and females using acceptable methods of contraception; current smokers or
ex-smokers having a history of at least 10 pack-years; subjects who had a stable disease for at
least 1 month and able to manage disease symptoms adequately; subjects willing to give
informed consent and able to comply with all study procedures were included in the study.
index <35 kg/m2 and females using acceptable methods of contraception; current smokers or
ex-smokers having a history of at least 10 pack-years; subjects who had a stable disease for at
least 1 month and able to manage disease symptoms adequately; subjects willing to give
informed consent and able to comply with all study procedures were included in the study.
主要排除條件
Subjects presenting with >2 exacerbations of COPD requiring treatment with oral steroids in
the preceding year or hospitalization for the treatment of COPD within 3 months of screening
or more than twice during the preceding year; history of a lower respiratory tract infection or
significant disease instability during the month preceding screening or during the time
between screening and randomization; history or presence of respiratory failure, cor
pulmonale or right ventricular failure; subjects with home oxygen therapy (either puffs as
required or long term oxygen therapy); any clearly documented history of adult asthma or
other chronic respiratory disorders (eg, bronchiectasis, pulmonary fibrosis, pneumoconiosis);
history of cancer (other than cutaneous basal cell) in the previous 5 years; history within the
previous year of myocardial infarction, cardiac arrhythmia (eg, atrial fibrillation, paroxysmal
atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia), left
ventricular failure, unstable angina, coronary angioplasty, coronary artery bypass grafting or
cerebrovascular accident (including transient ischemic attacks); active tuberculosis within the
previous 2 years; and history within the previous 6 months of an epileptic seizure, poorly
controlled Type 1 or Type 2 diabetes, acute hepatitis of any etiology, atrioventricular
block >first degree were excluded from the study.
the preceding year or hospitalization for the treatment of COPD within 3 months of screening
or more than twice during the preceding year; history of a lower respiratory tract infection or
significant disease instability during the month preceding screening or during the time
between screening and randomization; history or presence of respiratory failure, cor
pulmonale or right ventricular failure; subjects with home oxygen therapy (either puffs as
required or long term oxygen therapy); any clearly documented history of adult asthma or
other chronic respiratory disorders (eg, bronchiectasis, pulmonary fibrosis, pneumoconiosis);
history of cancer (other than cutaneous basal cell) in the previous 5 years; history within the
previous year of myocardial infarction, cardiac arrhythmia (eg, atrial fibrillation, paroxysmal
atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia), left
ventricular failure, unstable angina, coronary angioplasty, coronary artery bypass grafting or
cerebrovascular accident (including transient ischemic attacks); active tuberculosis within the
previous 2 years; and history within the previous 6 months of an epileptic seizure, poorly
controlled Type 1 or Type 2 diabetes, acute hepatitis of any etiology, atrioventricular
block >first degree were excluded from the study.
試驗計畫預計收納受試者人數
-
台灣人數
1000 人
-
全球人數
1000 人
