NCT01465906Unknown4 期
Efficacy and Safety of Tulobuterol Patch Combined With Tiotropium Bromide for Relieving Dyspnea Symptom of Chronic Obstructive Pulmonary Disease
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2010年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- PFT values (pulmonary function test, see description below)
研究概览
简要总结
Phrase: IV
Indication: dyspnea symptom of chronic obstructive pulmonary disease (COPD)
Objective: to evaluate efficacy and safety of tulobuterol patch combined with Tiotropium bromide for relieving dyspnea symptom of COPD
Design: a multi-centre randomized parallel blank control study
Case number: test group 80, control group 80, totally 160
Site number:7
Study period: 2010.9 - 2011.8
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •people aging from 40 to 80 with self ability of judgment
- •out-patients diagnosed as stable COPD according to "diagnosing and treatment guideline of COPD (2007 edition)" by Respiratory Department of Chinese Medical Association
- •PFT value at screen phase meet the standard as follows: FEV1/FVC < 70% and FEV1% among 30%-80% 15 mins after inhalation of 400ug Ventolin (i.e., moderate and severe COPD patients ).
- •people who can use Tiotropium Bromide powder inhalation device
- •people who join the study voluntarily and sign ICF (Informed Consent Form)
排除标准
- •people who have other acute or chronic respiratory diseases which may cause impairment of pulmonary function such as asthma
- •AECOPD （acute exacerbation of COPD）
- •people who got respiratory failure 1 month before the study
- •people who received oral corticoid treatment 1 month before the study
- •people who undergo oxygen therapy at home because of respiratory failure
- •people who are allergic to β2 receptor agonist such as tulobuterol
- •patients with Skin diseases such as atopic dermatitis, who are not appropriate to use transdermal patch
- •patients of hyperthyroidism, hypertension, heart disease and severe arrhythmia, diabetes mellitus, who are not appropriate to useβ2 receptor agonist
- •patients who have undergone pulmonary lobectomy or have tumor
- •active tuberculosis patients
- •people who got acute respiratory tract infection in a month or during screening phase
- •allergic rhinitis patients
- •glaucoma patients
- •people who have diseases which may cause dysuria such as prostatic hypertrophy or bladder neck occlusion
- •gestation, lactation and child-bearing age women who don't agree to take contraceptive measures during the study
- •people with abnormal live or kidney function, people with nervous system diseases, malignant tumor, neutropenia or other progressive basic diseases.
- •People who are mental retardation, mentally ill, deaf-mute or uncooperative, who cannot correctly describe their disease or do corresponding respiratory questionnaire.
- •People who are allergic to atropine and its derivatives (including tiotropium bromide and ipratropium bromide), lactose or any inhalant components.
- •people who have taken part in other medical clinical trial
- •other conditions that investigators think not appropriate for the study
研究组 & 干预措施
tulobuterol combined with tiotropium bromide
Experimental
干预措施: tulobuterol (Drug)
tulobuterol combined with tiotropium bromide
Experimental
干预措施: tiotropium bromide (Drug)
Tiotropium bromide
Active Comparator
干预措施: tiotropium bromide (Drug)
结局指标
主要结局
PFT values (pulmonary function test, see description below)
时间窗: 3 months
IC (inspiratory capacity) 、PEF (peak expiratory flow)、FVC (forced vital capacity)、FEV1 (forced expiratory volume in the first second)、%FEV1 (forced expiratory volume in the first second as predicted)、RV (residual volume)、TLC (total lung capacity)、RV/TLC% (residual volume/total lung capacity as percentage), etc.
MRC （Medical Research Council） grade
时间窗: 3 months
次要结局
- SGRQ （St. George's questionnaire） score(3 months)
研究者
Chunxue Bai
Director of Respiratory Department , Shanghai Zhongshan Hospita
Shanghai Zhongshan Hospital
研究点 (1)
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