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

NCT05295355 | Unknown DMC

• 1 other identifier: OCT-COPD
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Effect of Tiotropium Bromide Combined With Odaterol on mean bronchial diameter change

  at week 52

• Effect of Tiotropium Bromide Combined With Odaterol on bronchial airway wall area change

  at week 52

• Effect of Tiotropium Bromide Combined With Odaterol on FEV1 change

  at week 52

• Effect of Tiotropium Bromide Combined With Odaterol on SGRQ total score change

  at week 52

• Effect of Tiotropium Bromide Combined With Odaterol on resonance frequency change

  at week 52

Study Arms (2)

Tiotropium Bromide Combined With Odaterol

EXPERIMENTAL

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

EXPERIMENTAL

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

Interventions

Tiotropium Bromide Combined With Odaterol DRUG

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

Also known as: Tiotropium BromideInhalation Aerosol Suspension

Tiotropium Bromide; Tiotropium Bromide Combined With Odaterol

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Guangzhou Institute of Respiratory Diseases

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shiyue Li, Doctor

  Guangzhou Institute of Respiratory Disease

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiyue Li, Doctor

CONTACT

+86 13902233825; lishiyue@188.com

Ziqing Zhou, Doctor

CONTACT

+86 13535580261; zhou.ziqing@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: December 10, 2021
• First Posted: March 25, 2022
• Study Start: January 25, 2021
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: October 21, 2022

Record last verified: 2022-10

Locations

CN (1)