Chronic Obstructive Pulmonary DiseaseNCT05295355
Effect of Tiotropium Bromide Combined With Odaterol on Small Airway Remodeling in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease
A study testing Tiotropium Bromide Combined With Odaterol in people with Chronic Obstructive Pulmonary Disease, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Tiotropium Bromide Combined With Odaterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2021to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Institute of Respiratory Diseases
Guangzhou, Guangdong, 510000
Shiyue Li, Professor, 13902233925
Shiyue Li, MD
About this study
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.
Read the 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
- Being tested
- Tiotropium Bromide Combined With Odaterol
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiotropium Bromide Combined With OdaterolDrug
Also called Tiotropium BromideInhalation Aerosol Suspension
2 puffs once daily at the same time of the day for 52 week
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Tiotropium Bromide Combined With Odaterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at week 52
Secondary outcomes (8)
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
Measured: 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
Measured: at week 52
Effect of Tiotropium Bromide Combined With Odaterol on FEV1 change
difference in change from baseline in trough FEV1 at week 52
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start25 Jan 2021
- Primary completionSep 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, ShiYue Li, Guangzhou Institute of Respiratory Disease
- Investigators
- Shiyue Li, Doctor, Principal investigator, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295355
- Sponsor's protocol ID
- OCT-COPD
- Status last verified
- Oct 2022
- First submitted
- 10 Dec 2021
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tiotropium Bromide Combined With Odaterol on Small Airway Remodeling in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05295355
- Acronym / sponsor ID
- OCT-COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tiotropium Bromide Combined With Odaterol | Experimental | Drug: Tiotropium Bromide Combined With OdaterolTiotropium 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 | Experimental | Drug: Tiotropium Bromide Combined With OdaterolTiotropium 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tiotropium Bromide Combined With OdaterolAlso: Tiotropium BromideInhalation Aerosol Suspension2 puffs once daily at the same time of the day for 52 week | Drug | Tiotropium Bromide, Tiotropium Bromide Combined With Odaterol |
Primary outcome
Effect of Tiotropium Bromide Combined With Odaterol on endobronchial lumen area change
Time frame: at week 52
difference in change from baseline in grade 7-9 endobronchial lumen area (Ai7-9) at week 52
8 secondary outcomes
Effect of Tiotropium Bromide Combined With Odaterol on mean bronchial diameter change
Time frame: at week 52
Effect of Tiotropium Bromide Combined With Odaterol on bronchial airway wall area change
Time frame: at week 52
Effect of Tiotropium Bromide Combined With Odaterol on FEV1 change
Time frame: at week 52
Effect of Tiotropium Bromide Combined With Odaterol on SGRQ total score change
Time frame: at week 52
Effect of Tiotropium Bromide Combined With Odaterol on resonance frequency change
Time frame: at week 52
Effect of Tiotropium Bromide Combined With Odaterol on peripheral airway resistance change
Time frame: at week 52
Effect of Tiotropium Bromide Combined With Odaterol on CAT total score change
Time frame: at week 52
Effect of Tiotropium Bromide Combined With Odaterol on mMRC total score change
Time frame: at week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiyue Li, Doctor principal investigator
Guangzhou Institute of Respiratory Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tiotropium Bromide Combined With Odaterol in people with Chronic Obstructive Pulmonary Disease, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiyue Li, Doctor (+86 13902233825, lishiyue@188.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Tiotropium Bromide Combined With Odaterol on endobronchial lumen area change (time frame: at week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.