Effect of Tiotropium Bromide Combined With Odaterol on Small Airway Remodeling in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Effect of Tiotropium Bromide Combined With Odaterol on endobronchial lumen area change
研究概览
简要总结
72 patients with mild to moderate chronic obstructive pulmonary disease were planned to be enrolled in this study and then treated with olodaterol combined with thiotropium bromide, and thiotropium bromide, respectively, for 52 weeks. To assess the effect of the test drug on small airway remodeling in patients.
详细描述
Studies have confirmed that thiotropium bromide combined with olodaterol can significantly improve airway inflammation, quality of life and pulmonary function in patients with stable COPD, without significantly increasing adverse reactions, which is worthy of clinical promotion. At present, there are few reports on the effect of thiotropium combined with olodaterol on airway remodeling in COPD patients, so this randomized, double-blind, parallel-controlled, single-center clinical trial was designed to compare the long-term effects of thiotropium combined with olodaterol, and thiotropium on small airway remodeling in patients with mild to moderate chronic obstructive pulmonary disease.
72 patients with mild to moderate chronic obstructive pulmonary disease were planned to be enrolled in this study. After screening examination, eligible subjects were randomly assigned to the test group or the control group in a 1:1 ratio and received olodaterol combined with thiotropium bromide, and thiotropium bromide, respectively, for 52 weeks. The effect of the test drug on small airway remodeling was assessed at 12, 26, and 52 weeks after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged ≥ 40 years;
- •Meet the diagnostic criteria of COPD, and GOLD grade I - II;
- •FEV1/FVC < 70% and FEV1 ≥ 50% of the expected value after the use of bronchodilators;
- •Patients must be able to complete all study-related steps, voluntarily participate in this study and sign the informed consen.
排除标准
- •Patients with asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, pulmonary embolism, bronchiolitis obliterans, paradoxical bronchospasm;
- •Patients with blood eosinophilia;
- •Patients with upper respiratory tract infection;
- •Patients with liver or renal insufficiency;
- •Patients with severe unstable systemic diseases or malignant tumors;
- •Patients with glaucoma, benign prostatic hyperplasia or bladder neck obstruction;
- •Patients with hypokalemia, hyperglycemia, diabetes, ketoacidosis or other serious systemic diseases such as heart, brain, liver, kidney, digestive system, endocrine system, immune system, blood;
- •Women of childbearing age who are pregnant, lactating or plan to become pregnant;
- •Patients who have undergone previous pneumonectomy or received lung volume reduction surgery within 12 months before screening;
- •Patients with mental illness;
- •Patients who have participated in other clinical trials within 3 months before screening;
- •Allergic constitution or known allergy to atropine or its derivatives (such as isopropylamine or oxytoluium) Or those who are allergic to the intervention drugs and their ingredients;
- •The researchers believe that it is not appropriate to participate in this clinical trial.
研究组 & 干预措施
Tiotropium Bromide Combined With Odaterol
Tiotropium O Datlow inhalation spray 60 bottles per bottle, each containing 2.5 tiotropium ammonium g (equivalent to 3.124 g of thiotropium bromide) and 2.5 2.5 g (equivalent to 2.736 2.736 g of hydrochloric acid) by O Datlow. ® The inhaler was inhaled and administered twice a time, once a day, at the same time every day for 52 weeks
干预措施: Tiotropium Bromide Combined With Odaterol (Drug)
Tiotropium Bromide
Tiotropium Bromide Spray (Si Lihua ® Neng Beile ®）： 0.22624mg/ml (calculated by tiotropium), 60 strokes per bottle, containing 2.5 µ g of tiotropium bromide per stroke, through Neng Beile ® Inhaler inhalation administration, 2 presses per inhalation, once a day, administered at the same time every day for 52 weeks.
干预措施: Tiotropium Bromide Combined With Odaterol (Drug)
结局指标
主要结局
Effect of Tiotropium Bromide Combined With Odaterol on endobronchial lumen area change
时间窗: at week 52
difference in change from baseline in grade 7-9 endobronchial lumen area (Ai7-9) at week 52
次要结局
- Effect of Tiotropium Bromide Combined With Odaterol on SGRQ total score change(at week 52)
- Effect of Tiotropium Bromide Combined With Odaterol on peripheral airway resistance change(at week 52)
- Effect of Tiotropium Bromide Combined With Odaterol on CAT total score change(at week 52)
- Effect of Tiotropium Bromide Combined With Odaterol on mean bronchial diameter change(at week 52)
- Effect of Tiotropium Bromide Combined With Odaterol on bronchial airway wall area change(at week 52)
- Effect of Tiotropium Bromide Combined With Odaterol on FEV1 change(at week 52)
- Effect of Tiotropium Bromide Combined With Odaterol on resonance frequency change(at week 52)
- Effect of Tiotropium Bromide Combined With Odaterol on mMRC total score change(at week 52)
研究者
ShiYue Li
Ph.D
Guangzhou Institute of Respiratory Disease