Clinical trial NCT03842839: Effect of Tiotropium on Airway Remodeling in Patients With Early Stage COPD Accessed by Optical Coherence Tomography
Official title: Effect of Tiotropium on Airway Remodeling in Patients With Early Stage COPD Accessed by Optical Coherence Tomography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Airway Remodeling
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change from baseline in the inner luminal area (Ai) of the 3th to 9th generation bronchi at month 24
timeFrame: Ai accessed by endobronchial optical coherence tomography will be obtained at baseline, month 24.
measure: Change from baseline in the inner luminal area (Ai) of the 3th to 9th generation bronchi at month 12
timeFrame: Ai accessed by endobronchial optical coherence tomography will be obtained at month 12.
Secondary outcomes:
measure: Change from baseline in the airway wall area percentage (Aw%) of the 3th to 9th generation bronchi at month 12
timeFrame: Aw% accessed by endobronchial optical coherence tomography will be obtained at baseline, month 12.
measure: Change from baseline in the airway wall area percentage (Aw%) of the 3th to 9th generation bronchi at month 24
timeFrame: Aw% accessed by endobronchial optical coherence tomography will be obtained at month24.
measure: Change from baseline in trough FEV1
timeFrame: Pulmonary function test will be performed at baseline, month 6, 12, 18 and 24.
measure: Change from baseline in resonant frequency (Fres) at month 6, 12, 18 and 24.
timeFrame: IOS will be performed at baseline, month 6, 12, 18 and 24.
measure: Change from baseline in peripheral airway resistance (R5-R20)
timeFrame: IOS will be performed at baseline, month 6, 12, 18 and 24.
measure: Total times of SABA usage
timeFrame: During the two years treatment period, times of SABA administration will be recored.
measure: Total dosage of SABA usage
timeFrame: During the two years treatment period, the dosage of SABA administration will be recored.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References: