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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiotropium (0-12 month) + SABA as needed | Experimental |
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| Tiotropium (0-24 month) + SABA as needed | Experimental |
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| SABA as needed only | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium Inhalation Powder [Spiriva] 0.018mg | Drug | Tiotropium bromide (Spiriva) capsule 18μg once daily inhaled. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the inner luminal area (Ai) of the 3th to 9th generation bronchi at month 24 | To evaluate the effects of Tiotropium in ameliorating airway remodeling in early stage COPD | Ai accessed by endobronchial optical coherence tomography will be obtained at baseline, month 24. |
| Change from baseline in the inner luminal area (Ai) of the 3th to 9th generation bronchi at month 12 | To evaluate the effects of Tiotropium in ameliorating airway remodeling in early stage COPD | Ai accessed by endobronchial optical coherence tomography will be obtained at month 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the airway wall area percentage (Aw%) of the 3th to 9th generation bronchi at month 12 | To evaluate the effects of Tiotropium in ameliorating airway remodeling in early stage COPD | Aw% accessed by endobronchial optical coherence tomography will be obtained at baseline, month 12. |
| Change from baseline in the airway wall area percentage (Aw%) of the 3th to 9th generation bronchi at month 24 |
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Key inclusion criteria
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510120 | China |
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| Salbutamol sulphate aerosol (Ventolin) 0.01mg | Drug | As needed use of salbutamol sulphate aerosol (Ventolin) when exacerbation happens |
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To evaluate the effects of Tiotropium in ameliorating airway remodeling in early stage COPD |
| Aw% accessed by endobronchial optical coherence tomography will be obtained at month24. |
| Change from baseline in trough FEV1 | To evaluate the effects of Tiotropium in improving lung function | Pulmonary function test will be performed at baseline, month 6, 12, 18 and 24. |
| Change from baseline in resonant frequency (Fres) at month 6, 12, 18 and 24. | To evaluate the effects of Tiotropium in improving lung function | IOS will be performed at baseline, month 6, 12, 18 and 24. |
| Change from baseline in peripheral airway resistance (R5-R20) | To evaluate the effects of Tiotropium in improving lung function | IOS will be performed at baseline, month 6, 12, 18 and 24. |
| Total times of SABA usage | To evaluate the times of SABA administration | During the two years treatment period, times of SABA administration will be recored. |
| Total dosage of SABA usage | To evaluate the dosage of SABA administration | During the two years treatment period, the dosage of SABA administration will be recored. |
| ID | Term |
|---|---|
| D056151 | Airway Remodeling |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069447 | Tiotropium Bromide |
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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