An interventional study of Tiotropium Bromide Combined With Odaterol in Chronic Obstructive Pulmonary Disease, sponsored by Guangzhou Institute of Respiratory Disease. Status unknown at 1 site in China. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2022-10-21.
Sponsored by Guangzhou Institute of Respiratory Disease · Not applicable, Interventional, and Health services research
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's planned enrollment of 72 is close to the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Guangzhou Institute of Respiratory Disease is the lead sponsor of 96 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
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
Drug: Tiotropium Bromide Combined With Odaterol
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.
Drug: Tiotropium Bromide Combined With Odaterol
2 puffs once daily at the same time of the day for 52 week
Also known as: Tiotropium BromideInhalation Aerosol Suspension
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
Time frame: at week 52
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
Time frame: at week 52
Effect of Tiotropium Bromide Combined With Odaterol on bronchial airway wall area change
difference in change from baseline in grade 7-9 bronchial airway wall area (Aw and Aw% 7-9) at week 52
Time frame: at week 52
Effect of Tiotropium Bromide Combined With Odaterol on FEV1 change
difference in change from baseline in trough FEV1 at week 52
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at week 52
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Guangzhou Institute of Respiratory Disease