Patients with mild-to-moderate COPD and treatable traits were enrolled based on the following criteria: 1. Post-bronchodilator FEV1/FVC < 0.70 and post-bronchodilator FEV1 = 50% of predicted values at baseline. 2. Blood eosinophil count = 100 cells/µL, with a CAT total score = 10 (and both cough and sputum item scores = 2). 3. At least one of the following events occurred in the year prior to b
Conditions
Interventions
short-acting beta-agonist (SABA) as-needed treatment group:as-needed SABA
Tiotropium treatment group:Tiotropium 18ug QD
Budesonide/Glycopyrronium/Formoterol Fumarate MDI treatment group:BGF MDI 320/14.4/9.6ug BID
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Participants must be aged between 40 and 80 years at Visit 1; 2. Participants may be of either sex. Female participants are eligible to participate only if they meet one of the following criteria: 1) not of childbearing potential (i.e., physiologically incapable of becoming pregnant, including any post-menopausal or surgically sterile females); or 2) of childbearing potential, with a negative pregnancy test at screening, and agree to use consistently and correctly a highly effective method of contraception from screening throughout the study period until the safety follow-up; 3. Informed consent must be obtained by having the participant sign and date a written informed consent form (Appendix A) prior to participating in any study-related procedures; 4. A COPD diagnosis must be established prior to randomization, defined as either a documented clinical history of COPD consistent with American Thoracic Society criteria or a post-bronchodilator FEV1/FVC ratio <0.70; 5. Participants must have COPD severity meeting the inclusion criterion of a post-bronchodilator FEV1 =50% of predicted value, with an approximate 1:2 ratio of mild to moderate COPD participants at baseline; 6. Participants must present with at least one predefined treatable trait, including: 1) peripheral blood eosinophil count =100 cells/µL; 2) CAT total score =10 with concurrent cough and sputum item scores =2; or 3) documentation of at least one of the following during the 12 months prior to screening: i) pre-bronchodilator FEV1 decline =60 mL, ii) CAT total score increase =2 points or SGRQ total score increase =4 points, or iii) one moderate COPD exacerbation event; 7. Participants must demonstrate adequate and correct technique in using a pressurized metered-dose inhaler (pMDI); 8. Good compliance: Participants must be willing and able to complete all visit assessments per the study protocol.
Exclusion criteria
Exclusion criteria: 1. The participant must not have any significant concurrent disease or condition (other than COPD) that, in the judgment of the investigator, could jeopardize the participant's safety by participating in the study, or could impair the efficacy or safety analysis if the disease/condition worsens during the treatment period; 2. Participants present with any of the following respiratory conditions: 1) History of asthma (including cough-variant asthma) or individuals considered by the investigator to have an asthma history; 2) Alpha-1 antitrypsin deficiency: Participants with COPD primarily caused by alpha-1 antitrypsin deficiency; 3) Other respiratory diseases: Those with active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung disease, or other active pulmonary diseases; 4) Lung resection: Participants who underwent lung volume reduction surgery within 12 months prior to the screening visit; 5) COPD exacerbation occurring within 8 weeks before Visit 1 or between Visit 1 and Visit 2 (defined as an acute worsening of COPD symptoms requiring treatment with oral corticosteroids or antibiotics); 6) Lower respiratory tract infection: Participants with lower respiratory tract infections that have not fully resolved within 30 days prior to Visit 1; 3. Participants with a history of severe acute exacerbations within 12 months prior to Visit 1 will be excluded; 4. Participants have used prohibited medications as specified in the protocol within the designated timeframes prior to screening; 5. Participants will be excluded for known hypersensitivity or intolerance to the investigational product, including allergy to budesonide (or any other corticosteroid component), formoterol (or any other ß2-agonist), glycopyrronium (or other muscarinic anticholinergic agents), or any excipient of the MDI device components; 6. Participants will be excluded if, in the investigator's judgment, they are unlikely to comply with the study procedures, restrictions, and requirements; 7. Female participants who are planning pregnancy, currently pregnant (confirmed by positive pregnancy test), or breastfeeding are excluded from the study; 8. Participants with a history of chronic alcohol abuse, ß-adrenergic blocker use (including ophthalmic preparations), or substance abuse that may impair protocol compliance will be excluded; 9. Participants requiring a spacer to compensate for inadequate hand-lung coordination in using the MDI are excluded from the study; 10. Participants currently enrolled in any other interventional clinical trial will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to the first clinically important deterioration (CID); | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety events;Spirometric parameters were measured, including: Forced Expiratory Volume in the first second (FEV?) Forced Vital Capacity (FVC) The ratio of FEV? to FVC (FEV?/FVC);Symptom score;The risk of acute exacerbations;The quality of life;The function of small airways; | — |
Countries
China
Contacts
Public ContactZhong Nanshan
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed