Effect of Tiotropium Bromide Combined With Odaterol 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 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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Tiotropium Bromide Combined With Odaterol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ziqing Zhou, Doctor; Phone Number: +86 13535580261; Email: zhou.ziqing@foxmail.com
• Study Contact Backup: Name: Shiyue Li, Doctor; Phone Number: +86 13902233825; Email: lishiyue@188.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Guangzhou Institute of Respiratory Diseases
      • Contact: Shiyue Li, Professor; Phone Number: 13902233925

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Tiotropium Bromide Combined With Odaterol; 2 puffs once daily at the same time of the day for 52 week; Other Names: Tiotropium BromideInhalation Aerosol Suspension
Experimental: 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.	Drug: Tiotropium Bromide Combined With Odaterol; 2 puffs once daily at the same time of the day for 52 week; Other Names: Tiotropium BromideInhalation Aerosol Suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Guangzhou Institute of Respiratory Disease
• Collaborators: Boehringer Ingelheim
• Investigators: Principal Investigator: Shiyue Li, Doctor, Guangzhou Institute of Respiratory Disease

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: December 10, 2021
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): October 21, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pathological Conditions, Anatomical; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Airway Remodeling; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Anticonvulsants; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide; Bromides
• Other Study ID Numbers: OCT-COPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No