Effect of Tiotropium Bromide Combined With Odaterol on Small Airway Remodeling in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Effect of Tiotropium Bromide Combined With Odaterol on Small Airway Remodeling in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05295355
• Other study ID #: OCT-COPD
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: March 2025

Study information

• Verified date: October 2022
• Source: Guangzhou Institute of Respiratory Disease
• Contact: Shiyue Li, Doctor
• Phone: +86 13902233825
• Email: lishiyue[@]188.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: March 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Airway Remodeling
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium Bromide Combined With Odaterol
2 puffs once daily at the same time of the day for 52 week

Locations

Country	Name	City	State
China	Guangzhou Institute of Respiratory Diseases	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease	Boehringer Ingelheim

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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	at week 52
Secondary	Effect of Tiotropium Bromide Combined With Odaterol on FEV1 change	difference in change from baseline in trough FEV1 at week 52	at week 52
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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