The Effects of Inhaled Budesonide-formoterol-glycopyrronium in Moderate-to-severe COPD
The Effects of Inhaled Budesonide-formoterol-glycopyrronium in Moderate-to-severe COPD
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.
Inclusion Criteria:

 -  With capability of communicating via oral conversation or written documents and
 signing informed consent.

 -  With capability of receiving and participating in study related auxiliary
 examinations.

 -  Age: 40-80 yrs, both male and female, with or without smoking history, receiving
 treatment in community hospitals or outpatient department in general hospitals

 -  GOLD Stage II-III COPD: FEV1/FVC<70% and FEV1 45-80% predicted (about 1/3 subjects in
 45%-50%), measured 20min after 400μg salbutamol inhalation

 -  With stable COPD (no COPD exacerbation during the latest 4 weeks prior to the
 recruitment) and irregular use of inhalation therapy, or regular use of inhalation
 therapy but no more than 2 weeks. Subject is willing and, in the opinion of the
 investigator, able to adjust current COPD therapy, as required by the protocol.

 Exclusion Criteria:

 -  Subjects are participating in other clinical research or have completed another
 clinical research within 3 months prior to screening.

 -  Significant diseases or conditions other than COPD. A significant disease or condition
 is defined as a disease or condition which, in the opinion of the investigator, may
 put the patient at risk because of participation in the study or may influence either
 the results of the study or the patients' ability to participate in the study

 -  Patients with clinical diagnosis of lung cancer, bronchiectasis, pneumoconiosis, or
 other single restricted ventilation.

 -  Severe cardiovascular, neural, hepatic, renal and hematologic diseases or malignancies
 that may interfere with the operation of the study.

 -  Patients with prostatic hyperplasia or bladder neck obstruction with significant
 symptoms, or narrow angle glaucoma

 -  Patients have a current and history diagnosis of asthma, or who have a blood
 eosinophil count ≥600/mm3 (0.6×109/L).

 -  Patients with active pulmonary tuberculosis

 -  Patients with life-threatening pulmonary embolism, α1-antitrypsin deficiency, or
 cystic fibrosis

 -  History of pneumonectomy.

 -  COPD exacerbation in 4 weeks prior to the first visit (V1), or hospitalization and/or
 antibiotic application and/or oral or intravenous glucocorticosteroids application is
 required during screening stage.

 -  Long-term oxygen therapy, frequent use of glucocorticosteroids orally or intravenously
 (prednisone>10mg/d), or long-term use of antibiotics.

 -  Women who are pregnant or lactating or are planning to become pregnant during the
 course of the study, or women of childbearing potential who are not using an
 acceptable method of contraception.

 -  Planned hospitalization or blood donation during the trial.

 -  Known hypersensitivity or intolerance to trial drugs.

 -  History of chronic alcohol or drug abuse, or any other conditions that may impact
 compliance.

 -  With contraindications to undergo bronchoscopy.