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

NCT ID: NCT05295355

Last Updated: 2022-10-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2025-03-31

Brief 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.

Detailed 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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Tiotropium Bromide Combined With Odaterol

Intervention Type: DRUG

2 puffs once daily at the same time of the day for 52 week

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.

Group Type: EXPERIMENTAL

Tiotropium Bromide Combined With Odaterol

Intervention Type: DRUG

2 puffs once daily at the same time of the day for 52 week

Interventions

Tiotropium Bromide Combined With Odaterol

2 puffs once daily at the same time of the day for 52 week

Intervention Type: DRUG

Other Intervention Names

Tiotropium BromideInhalation Aerosol Suspension

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role: lead

Responsible Party

ShiYue Li

Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shiyue Li, Doctor

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Institute of Respiratory Disease

Locations

Guangzhou Institute of Respiratory Diseases

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shiyue Li, Doctor

Role: CONTACT

lishiyue@188.com

+86 13902233825

Ziqing Zhou, Doctor

Role: CONTACT

zhou.ziqing@foxmail.com

+86 13535580261

Facility Contacts

Shiyue Li, Professor

Role: primary

13902233925

Other Identifiers

OCT-COPD

Identifier Type: -

Identifier Source: org_study_id