Airway RemodelingNCT03842839
Effect of Tiotropium on Airway Remodeling in Patients With Early Stage COPD Accessed by Optical Coherence Tomography
A study testing Tiotropium Inhalation Powder [Spiriva] 0.018mg and Salbutamol sulphate aerosol (Ventolin) 0.1mg in people with Airway Remodeling and Chronic Obstructive Pulmonary Disease, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
This randomized, open-label, three-arm clinical trial evaluated the effects of tiotropium on airway remodeling in patients with GOLD stage 1 COPD using endobronchial optical coherence tomography (EB-OCT). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Airway Remodeling, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Tiotropium Inhalation Powder [Spiriva] 0.018mg and Salbutamol sulphate aerosol (Ventolin) 0.1mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 7 May 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 40 yrs; Male or female Diagnosed with COPD
- Post-bronchodilator FEV1/FVC <0.70 and FEV1 ≥80% predicted;
- Patients must be able to perform all study related procedures
Who cannot join
- Patients with other lung diseases (such as bronchiectasis, pneumothorax, pleural effusion, airway deformation, lung surgery, etc.).
- Patients have poor compliance and are unwilling to receive medication regularly.
- Other complications of bronchoscopy or intolerance of bronchoscopy procedure.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
About this study
This randomized, open-label, three-arm clinical trial evaluated the effects of tiotropium on airway remodeling in patients with GOLD stage 1 COPD using endobronchial optical coherence tomography (EB-OCT). Participants were randomly assigned to receive tiotropium for 12 months followed by withdrawal for months 12-24, tiotropium continuously for 24 months, or SABA as needed without regular long-acting bronchodilator therapy. Airway morphology, pulmonary function, impulse oscillometry, and SABA use were assessed during the 24-month follow-up.
- Being tested
- Tiotropium Inhalation Powder [Spiriva] 0.018mg, Salbutamol sulphate aerosol (Ventolin) 0.1mg
- Keywords
- Tiotropium, Endobronchial Optical Coherence Tomography, GOLD 1 COPD, Airway Morphology, Small Airways
- Medical subject headings
- Airway Remodeling, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiotropium Inhalation Powder [Spiriva] 0.018mgDrug
Also called Spiriva
Tiotropium bromide (Spiriva) capsule 18μg once daily inhaled.
Salbutamol sulphate aerosol (Ventolin) 0.1mgDrug
Also called Ventolin
Salbutamol inhalation aerosol (Ventolin), 100 μg per actuation, was available as needed for symptom relief throughout the 24-month study period.
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium (0-12 month) + SABA as needed | Experimental | * During the 2 years treatment phase patients will be administered with tiotropium bromide (Spiriva) capsule 18μg once daily from baseline to the 12th months.
* Scheduled tiotropium treatment was discontinued after month 12. Additional maintenance inhaled therapy was permitted if clinically indicated and was recorded.
* Salbutamol sulphate aerosol (Ventolin) was available as needed for symptom relief throughout the 24-month follow-up. Receives: Drug: Tiotropium Inhalation Powder [Spiriva] 0.018mg; Drug: Salbutamol sulphate aerosol (Ventolin) 0.1mg |
| Tiotropium (0-24 month) + SABA as needed | Experimental | * During the 2 years treatment phase patients will be administered with tiotropium bromide (Spiriva) capsule 18μg once daily from baseline to the 24th months.
* Salbutamol sulphate aerosol (Ventolin) was available as needed for symptom relief throughout the 24-month follow-up. Receives: Drug: Tiotropium Inhalation Powder [Spiriva] 0.018mg; Drug: Salbutamol sulphate aerosol (Ventolin) 0.1mg |
| SABA as needed only | Other | * During the 24-month study period, salbutamol inhalation aerosol (Ventolin) was available as needed for symptom relief.
* No scheduled long-acting bronchodilator was assigned in this group. Additional maintenance inhaled therapy was permitted if clinically indicated and was recorded. Receives: Drug: Salbutamol sulphate aerosol (Ventolin) 0.1mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in inner luminal area (Ai) of small airways (7th to 9th generation bronchi) at month 24
To evaluate the effects of tiotropium on structural remodeling of small airways in patients with early-stage COPD.
Measured: Baseline and month 24
Secondary outcomes (7)
Change from baseline in inner luminal area (Ai) of small airways (7th to 9th generation bronchi) at month 12
Change from baseline to month 12 in patient-level mean airway luminal area of generations 7-9, measured by EB-OCT (mm²).
Measured: Baseline and Month 12
Change from baseline in inner luminal area (Ai) of 3rd-6th generation bronchi
To evaluate the effects of tiotropium on structural remodeling of medium-sized airways in patients with early-stage COPD.
Measured: Baseline, Month 12, and Month 24
Change from baseline in the airway wall area percentage (Aw%) of the 7th to 9th generation bronchi
To evaluate the effects of Tiotropium in ameliorating airway remodeling in early stage COPD
Measured: Baseline, Month 12, and Month 24
Change from baseline in the airway wall area percentage (Aw%) of the 3rd to 6th generation bronchi
To evaluate the effects of Tiotropium in ameliorating airway remodeling in early stage COPD
Measured: Baseline, Month 12, and Month 24
Change from baseline in trough FEV1
To evaluate the effects of Tiotropium in improving lung function
Measured: Baseline, Month 12, and Month 24
Change from baseline in peripheral airway resistance (R5-R20)
To evaluate the effects of Tiotropium in improving lung function
Measured: Baseline, Month 12, and Month 24
Change from baseline in COPD Assessment Test (CAT) score
Change from baseline in COPD Assessment Test (CAT) score
Measured: Baseline, Month 12, and Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Aug 2019
- Primary completion7 May 2025
- Study completion7 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway RemodelingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShiYue Li, Guangzhou Institute of Respiratory Disease
- Investigators
- Shiyue Li, MD, Principal investigator, Guangzhou Institute of Respiratory Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842839
- Sponsor's protocol ID
- ESCOPD-20181001
- Status last verified
- Oct 2026
- First submitted
- 21 Jan 2019
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data underlying the published results may be shared upon reasonable request, subject to institutional approval, applicable consent restrictions, and a data-use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tiotropium on Airway Remodeling in Patients With Early Stage COPD Accessed by Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT03842839
- Acronym / sponsor ID
- ESCOPD-20181001
- Keywords
- Tiotropium, Endobronchial Optical Coherence Tomography, GOLD 1 COPD, Airway Morphology, Small Airways
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 7 May 2025 (actual)
- First posted
- 15 Feb 2019 (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.
This randomized, open-label, three-arm clinical trial evaluated the effects of tiotropium on airway remodeling in patients with GOLD stage 1 COPD using endobronchial optical coherence tomography (EB-OCT). Participants were randomly assigned to receive tiotropium for 12 months followed by withdrawal for months 12-24, tiotropium continuously for 24 months, or SABA as needed without regular long-acting bronchodilator therapy. Airway morphology, pulmonary function, impulse oscillometry, and SABA use were assessed during the 24-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tiotropium (0-12 month) + SABA as needed | Experimental | Drug: Tiotropium Inhalation Powder [Spiriva] 0.018mg, Drug: Salbutamol sulphate aerosol (Ventolin) 0.1mg* During the 2 years treatment phase patients will be administered with tiotropium bromide (Spiriva) capsule 18μg once daily from baseline to the 12th months. * Scheduled tiotropium treatment was discontinued after month 12. Additional maintenance inhaled therapy was permitted if clinically indicated and was recorded. * Salbutamol sulphate aerosol (Ventolin) was available as needed for symptom relief throughout the 24-month follow-up. |
| Tiotropium (0-24 month) + SABA as needed | Experimental | Drug: Tiotropium Inhalation Powder [Spiriva] 0.018mg, Drug: Salbutamol sulphate aerosol (Ventolin) 0.1mg* During the 2 years treatment phase patients will be administered with tiotropium bromide (Spiriva) capsule 18μg once daily from baseline to the 24th months. * Salbutamol sulphate aerosol (Ventolin) was available as needed for symptom relief throughout the 24-month follow-up. |
| SABA as needed only | Other | Drug: Salbutamol sulphate aerosol (Ventolin) 0.1mg* During the 24-month study period, salbutamol inhalation aerosol (Ventolin) was available as needed for symptom relief. * No scheduled long-acting bronchodilator was assigned in this group. Additional maintenance inhaled therapy was permitted if clinically indicated and was recorded. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 40 yrs; Male or female Diagnosed with COPD
- Post-bronchodilator FEV1/FVC <0.70 and FEV1 ≥80% predicted;
- Patients must be able to perform all study related procedures
Key exclusion criteria (3 listed)
- Patients with other lung diseases (such as bronchiectasis, pneumothorax, pleural effusion, airway deformation, lung surgery, etc.).
- Patients have poor compliance and are unwilling to receive medication regularly.
- Other complications of bronchoscopy or intolerance of bronchoscopy procedure.
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 Inhalation Powder [Spiriva] 0.018mgAlso: SpirivaTiotropium bromide (Spiriva) capsule 18μg once daily inhaled. | Drug | Tiotropium (0-12 month) + SABA as needed, Tiotropium (0-24 month) + SABA as needed |
| Salbutamol sulphate aerosol (Ventolin) 0.1mgAlso: VentolinSalbutamol inhalation aerosol (Ventolin), 100 μg per actuation, was available as needed for symptom relief throughout the 24-month study period. | Drug | SABA as needed only, Tiotropium (0-12 month) + SABA as needed, Tiotropium (0-24 month) + SABA as needed |
Primary outcome
Change from baseline in inner luminal area (Ai) of small airways (7th to 9th generation bronchi) at month 24
Time frame: Baseline and month 24
To evaluate the effects of tiotropium on structural remodeling of small airways in patients with early-stage COPD.
7 secondary outcomes
Change from baseline in inner luminal area (Ai) of small airways (7th to 9th generation bronchi) at month 12
Time frame: Baseline and Month 12
Change from baseline in inner luminal area (Ai) of 3rd-6th generation bronchi
Time frame: Baseline, Month 12, and Month 24
Change from baseline in the airway wall area percentage (Aw%) of the 7th to 9th generation bronchi
Time frame: Baseline, Month 12, and Month 24
Change from baseline in the airway wall area percentage (Aw%) of the 3rd to 6th generation bronchi
Time frame: Baseline, Month 12, and Month 24
Change from baseline in trough FEV1
Time frame: Baseline, Month 12, and Month 24
Change from baseline in peripheral airway resistance (R5-R20)
Time frame: Baseline, Month 12, and Month 24
Change from baseline in COPD Assessment Test (CAT) score
Time frame: Baseline, Month 12, and Month 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data underlying the published results may be shared upon reasonable request, subject to institutional approval, applicable consent restrictions, and a data-use agreement.
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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, MD principal investigator
Guangzhou Institute of Respiratory Health
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 Inhalation Powder [Spiriva] 0.018mg and Salbutamol sulphate aerosol (Ventolin) 0.1mg in people with Airway Remodeling and 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 21 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in inner luminal area (Ai) of small airways (7th to 9th generation bronchi) at month 24 (time frame: Baseline and month 24). 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 2026.