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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tiotropium Bromide Combined With Odaterol
Sponsored by
Guangzhou Institute of Respiratory Disease
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guangzhou Institute of Respiratory DiseasesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tiotropium Bromide Combined With Odaterol

Tiotropium Bromide

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Effect of Tiotropium Bromide Combined With Odaterol on FEV1 change
difference in change from baseline in trough FEV1 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
Effect of Tiotropium Bromide Combined With Odaterol on resonance frequency change
difference in change from baseline in resonance frequency (Fres) 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
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
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

Full Information

First Posted
December 10, 2021
Last Updated
October 19, 2022
Sponsor
Guangzhou Institute of Respiratory Disease
Collaborators
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT05295355
Brief Title
Effect of Tiotropium Bromide Combined With Odaterol on Small Airway Remodeling in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease
Official Title
Effect of Tiotropium Bromide Combined With Odaterol on Small Airway Remodeling in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Institute of Respiratory Disease
Collaborators
Boehringer Ingelheim

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tiotropium Bromide Combined With Odaterol
Arm Type
Experimental
Arm Description
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
Arm Title
Tiotropium Bromide
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Tiotropium Bromide Combined With Odaterol
Other Intervention Name(s)
Tiotropium BromideInhalation Aerosol Suspension
Intervention Description
2 puffs once daily at the same time of the day for 52 week
Primary Outcome Measure Information:
Title
Effect of Tiotropium Bromide Combined With Odaterol on endobronchial lumen area change
Description
difference in change from baseline in grade 7-9 endobronchial lumen area (Ai7-9) at week 52
Time Frame
at week 52
Secondary Outcome Measure Information:
Title
Effect of Tiotropium Bromide Combined With Odaterol on mean bronchial diameter change
Description
difference in change from baseline in grade 7-9 mean bronchial diameter (Dmean7-9) at week 52
Time Frame
at week 52
Title
Effect of Tiotropium Bromide Combined With Odaterol on bronchial airway wall area change
Description
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
Title
Effect of Tiotropium Bromide Combined With Odaterol on FEV1 change
Description
difference in change from baseline in trough FEV1 at week 52
Time Frame
at week 52
Title
Effect of Tiotropium Bromide Combined With Odaterol on SGRQ total score change
Description
difference in change from baseline in SGRQ （ST george's respiratory questionaire）total score at week 52
Time Frame
at week 52
Title
Effect of Tiotropium Bromide Combined With Odaterol on resonance frequency change
Description
difference in change from baseline in resonance frequency (Fres) at week 52
Time Frame
at week 52
Title
Effect of Tiotropium Bromide Combined With Odaterol on peripheral airway resistance change
Description
difference in change from baseline in peripheral airway resistance (R5-R20) at week 52
Time Frame
at week 52
Title
Effect of Tiotropium Bromide Combined With Odaterol on CAT total score change
Description
difference in change from baseline in CAT（Chronic obstructive pulmonary disease assessment test） total score at week 52
Time Frame
at week 52
Title
Effect of Tiotropium Bromide Combined With Odaterol on mMRC total score change
Description
difference in change from baseline in mMRC（Modified British medical research council） total score at week 52
Time Frame
at week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shiyue Li, Doctor
Phone
+86 13902233825
Email
lishiyue@188.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ziqing Zhou, Doctor
Phone
+86 13535580261
Email
zhou.ziqing@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiyue Li, Doctor
Organizational Affiliation
Guangzhou Institute of Respiratory Disease
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou Institute of Respiratory Diseases
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiyue Li, Professor
Phone
13902233925
First Name & Middle Initial & Last Name & Degree
Shiyue Li, MD

12. IPD Sharing Statement

Learn more about this trial

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

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