The fixed-dose combination product Budesonide/Glycopyrronium/Formoterol Fumarate Inhalation Aerosol, BGF pMDI and dual combination product Glycopyrronium/Formoterol Fumarate Inhalation Aerosol , GFF pMDI are developed for maintenance treatment for patients with COPD. There are still some unmet medical needs and evidence gaps in COPD therapy, such as could BGF Inhalation Aerosphere reverse the disease progression such like airway-remodelling? Could BGF Inhalation Aerosphere reduce inflammation in small airways? Before differences proven between medication groups, pilot study is needed. This 52 weeks, Single-center, prospective, interventional pilot study could help discovering intervention effect of BGF and GFF on small airways through OCT measurement, which would show outcome of AEROSPHERE™ Delivery Technology on COPD patients.
The subjects eligible for this study will receive a 52-week of BGF or GFF treatment, and a 30 days follow-up telephone call after the last study drug dose.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Budesonide/Glycopyrronium/Formoterol: 160/7.2/4.8/ puff, twice daily with two puffs per time
Glycopyrronium/Formoterol: 7.2/4.8 per puff, twice daily with two puffs per time
Guangzhou Institute of Respiratory Diseases
Guangzhou, Guangdong, China
The effect of BGF and GFF on inner luminal area change
Change from baseline in the inner luminal area of the 7th to 9th generation bronchi (Ai7-9) at month 12 measured by Endobronchial optical coherence tomography (EB-OCT)
Time frame: 12 months
The effect of BGF and GFF on luminal diameter change
•Change from baseline in mean luminal diameter of the 7th to 9th generation bronchi (Dmean7-9) at month 12 measured by EB-OCT
Time frame: 12 months
The effect of BGF and GFF on airway wall area change
•Change from baseline in airway wall area percentage of the 7th to 9th generation bronchi (Aw%7-9) at month 12 measured by EB-OCT
Time frame: 12 months
The effect of BGF and GFF on resonant frequency
•Change from baseline in resonant frequency (Fres) at month 6 and 12 measured by impulse oscillometry (IOS)
Time frame: 12 months
The effect of BGF and GFF on peripheral airway resistance
•Change from baseline in peripheral airway resistance (R5-R20) at month 6 and 12 measured by IOS
Time frame: 12 months
The effect of BGF and GFF on lung function including FEV1, FVC,FEV1%
•Change from baseline in trough FEV1, FVC and FEV1% at month 6 and 12 measured by spirometry
Time frame: 12 months
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