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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Enrollment
72
2 puffs once daily at the same time of the day for 52 week
Guangzhou Institute of Respiratory Diseases
Guangzhou, Guangdong, China
RECRUITINGEffect 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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