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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiotropium Bromide Combined With Odaterol | Experimental | 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 |
|
| Tiotropium Bromide | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium Bromide Combined With Odaterol | Drug | 2 puffs once daily at the same time of the day for 52 week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Tiotropium Bromide Combined With Odaterol on endobronchial lumen area change | difference in change from baseline in grade 7-9 endobronchial lumen area (Ai7-9) at week 52 | at week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Tiotropium Bromide Combined With Odaterol on mean bronchial diameter change | difference in change from baseline in grade 7-9 mean bronchial diameter (Dmean7-9) at week 52 | at week 52 |
| Effect of Tiotropium Bromide Combined With Odaterol on bronchial airway wall area change |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiyue Li, Doctor | Contact | +86 13902233825 | lishiyue@188.com | |
| Ziqing Zhou, Doctor | Contact | +86 13535580261 | zhou.ziqing@foxmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shiyue Li, Doctor | Guangzhou Institute of Respiratory Disease | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Institute of Respiratory Diseases | Recruiting | Guangzhou | Guangdong | 510000 | China |
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difference in change from baseline in grade 7-9 bronchial airway wall area (Aw and Aw% 7-9) at week 52 |
| at week 52 |
| Effect of Tiotropium Bromide Combined With Odaterol on FEV1 change | difference in change from baseline in trough FEV1 at week 52 | at week 52 |
| Effect of Tiotropium Bromide Combined With Odaterol on SGRQ total score change | difference in change from baseline in SGRQ (ST george's respiratory questionaire)total score at week 52 | at week 52 |
| Effect of Tiotropium Bromide Combined With Odaterol on resonance frequency change | difference in change from baseline in resonance frequency (Fres) at week 52 | at week 52 |
| Effect of Tiotropium Bromide Combined With Odaterol on peripheral airway resistance change | difference in change from baseline in peripheral airway resistance (R5-R20) at week 52 | at week 52 |
| Effect of Tiotropium Bromide Combined With Odaterol on CAT total score change | difference in change from baseline in CAT(Chronic obstructive pulmonary disease assessment test) total score at week 52 | at week 52 |
| Effect of Tiotropium Bromide Combined With Odaterol on mMRC total score change | difference in change from baseline in mMRC(Modified British medical research council) total score at week 52 | at week 52 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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