Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide/Glycopyrronium/Formoterol arm | Other | 52 weeks treatment |
|
| Glycopyrronium/Formoterol arm | Other | 52 weeks treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGF Inhalation Aerosphere | Drug | Budesonide/Glycopyrronium/Formoterol: 160/7.2/4.8/ puff, twice daily with two puffs per time |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| The effect of BGF and GFF on airway wall area change |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Objective: change of Quality of life | • the effects of BGF and GFF in improving quality of life measured by St. George's Respiratory Questionnaire (SGRQ),Scores range from 0 to 100, with higher scores indicating more limitations. | 12 months |
| Exploratory Objective: change of emphysema |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiyue Li, Doctor | Contact | +86 13902233925 | lishiyue@188.com | |
| Ziqing Zhou, Doctor | Contact | +86 13535580261 | zhou.ziqing@foxmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shiyue Li, Doctor | Guangzhou Institute of Respiratory Disease | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou Institute of Respiratory Diseases | Guangzhou | Guangdong | 510000 | China |
Not provided
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| GFF Inhalation Aerosphere | Drug | Glycopyrronium/Formoterol: 7.2/4.8 per puff, twice daily with two puffs per time |
|
|
•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
| 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) | 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 | 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 | 12 months |
•the effects of BGF and GFF in reducing emphysema measured by Computer Tomography(CT) |
| 12 months |
| Exploratory Objective: TNF-α | • the effects of BGF and GFF in ameliorating COPD inflammation measured by TNF-α in sputum | 12 months |
| Exploratory Objective: IL-1β | • the effects of BGF and GFF in ameliorating COPD inflammation measured by IL-1β in sputum | 12 months |
| Exploratory Objective: MMP-8 | • the effects of BGF and GFF in ameliorating COPD inflammation measured by MMP-8 in sputum | 12 months |
| Exploratory Objective: MMP-12 | • the effects of BGF and GFF in ameliorating COPD inflammation measured by MMP-12 in sputum | 12 months |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |