Airway Remodeling
Conditions
Brief summary
The study aims to explore the effect of tiotropium on airway remodeling by using Endobronchial Optical Coherence Tomography (EB-OCT). We enrolled patients with GOLD I stage COPD. All the patients will be divided into four groups randomly to receive SABA as needed with or without regular use of tiotropium. Changes of airway morphology (accessed by EB-OCT), pulmonary function, QOL, and SABA usage will be obtained.
Interventions
DRUGTiotropium Inhalation Powder [Spiriva] 0.018mg
Tiotropium bromide (Spiriva) capsule 18μg once daily inhaled.
DRUGSalbutamol sulphate aerosol (Ventolin) 0.01mg
As needed use of salbutamol sulphate aerosol (Ventolin) when exacerbation happens
Sponsors
Guangzhou Institute of Respiratory Disease
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key inclusion criteria * Over 40 yrs; Male or female Diagnosed with COPD * Pre-bronchodilator FEV1 ≥80% pred ; * Patients must be able to perform all study related procedures
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the inner luminal area (Ai) of the 3th to 9th generation bronchi at month 24 | Ai accessed by endobronchial optical coherence tomography will be obtained at baseline, month 24. | To evaluate the effects of Tiotropium in ameliorating airway remodeling in early stage COPD |
| Change from baseline in the inner luminal area (Ai) of the 3th to 9th generation bronchi at month 12 | Ai accessed by endobronchial optical coherence tomography will be obtained at month 12. | To evaluate the effects of Tiotropium in ameliorating airway remodeling in early stage COPD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in trough FEV1 | Pulmonary function test will be performed at baseline, month 6, 12, 18 and 24. | To evaluate the effects of Tiotropium in improving lung function |
| Change from baseline in resonant frequency (Fres) at month 6, 12, 18 and 24. | IOS will be performed at baseline, month 6, 12, 18 and 24. | To evaluate the effects of Tiotropium in improving lung function |
| Change from baseline in the airway wall area percentage (Aw%) of the 3th to 9th generation bronchi at month 12 | Aw% accessed by endobronchial optical coherence tomography will be obtained at baseline, month 12. | To evaluate the effects of Tiotropium in ameliorating airway remodeling in early stage COPD |
| Total times of SABA usage | During the two years treatment period, times of SABA administration will be recored. | To evaluate the times of SABA administration |
| Total dosage of SABA usage | During the two years treatment period, the dosage of SABA administration will be recored. | To evaluate the dosage of SABA administration |
| Change from baseline in peripheral airway resistance (R5-R20) | IOS will be performed at baseline, month 6, 12, 18 and 24. | To evaluate the effects of Tiotropium in improving lung function |
| Change from baseline in the airway wall area percentage (Aw%) of the 3th to 9th generation bronchi at month 24 | Aw% accessed by endobronchial optical coherence tomography will be obtained at month24. | To evaluate the effects of Tiotropium in ameliorating airway remodeling in early stage COPD |
Countries
China
Outcome results
None listed