Chronic obstructive pulmonary disease
Conditions
Interventions
Experimental group:Umeclidinium Bromide and Vilanterol Trifenatate Powder for Inhalation from Jiangsu Chia Tai Tianqing Pharmaceutical Group Co., Ltd, once daily via oral inhalation.
Control group:Umeclidinium Bromide and Vilanterol Trifenatate Powder for Inhalation from Glaxo Group Limited, administered once daily via oral inhalation.
Sponsors
Shenzhen People's Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The subject voluntarily participates in this study, signs the informed consent form, and fully understands the purpose, process of the trial and possible adverse reactions. 2. Both genders are eligible, aged >= 40 years and = 10 pack-years, or a history of exposure to biofuels. [Pack-years = (number of cigarettes smoked per day / 20) × years of smoking; for example, smoking 20 cigarettes per day for 10 consecutive years or 10 cigarettes per day for 20 consecutive years, both are 10 pack-years]. A former smoker is defined as having quit smoking for at least 6 months before Visit 1. Note: The use of pipes, cigars, and e-cigarettes cannot be used to calculate pack-years. 6. At Visit 1 (screening visit), after the application of bronchodilators, the FEV1/FVC ratio is = 30% and 0.70 L. 7. Within 1 month before Visit 1, the patient has not received treatment, only used rescue medication, or received stable-dose monotherapy maintenance treatment (LAMA, LABA, ICS), or stable-dose dual-drug maintenance treatment (LAMA/LABA or ICS/LABA); triple-drug maintenance treatment (LAMA/LABA/ICS) is not allowed within 1 month before Visit 1. The discontinuation of triple-drug treatment 1 month before Visit 1 must be determined by the researcher based on the patient's clinical symptoms. 8. At Visit 1 and Visit 2, the score of the modified Medical Research Council Dyspnea Scale (mMRC) is >= 1. 9. Subjects who can cooperate and have the ability to receive training to correctly use drug inhalers (pMDI, DPI). 10. The subject has good compliance during the run-in period (including medication compliance during the run-in period >= 70% and <=130%). 11. Male or female subjects of childbearing potential must agree and commit to using medically accepted contraceptive methods throughout the study period and for at least 6 months after the last administration of the trial drug. 12. The subject is able to attend the study visits on time and complete the visit content.
Exclusion criteria
Exclusion criteria: 1. Other respiratory diseases: alpha-1 antitrypsin deficiency, primary ciliary dyskinesia, active pulmonary infection (such as tuberculosis), lung cancer, bronchiectasis, pulmonary fibrosis, cystic fibrosis, obesity-related hypoventilation syndrome, pulmonary sarcoidosis, pulmonary arterial hypertension, interstitial lung disease and other clinically significant respiratory diseases; 2. Patients with a current diagnosis of asthma or subjects with a documented history of asthma; 3. Subjects who had undergone previous pneumonectomy, or underwent lung volume reduction surgery within 12 months before visit 1, or anticipated need for lung volume reduction surgery during the study; 4. Moderate-to-severe acute exacerbations of COPD occurred within 8 weeks before visit 1 or between visit 1 and visit 2; Or patients who received standard treatment for COPD within 1 year before visit 1 and had acute exacerbations leading to hospitalization more than 2 times; 5. Pneumonia or lower respiratory tract infection requiring antibiotic treatment occurred within 8 weeks before visit 1 or between visit 1 and visit 2. 6. COVID-19: suspected by laboratory confirmation or based on the investigator's medical judgment at screening (V1) or during introduction Plausible or confirmed COVID-19 infection; Subjects known to have been in contact with COVID-19 positive patients. Note: Subjects should remain asymptomatic for 14 days or more after exposure, and subjects may be re-screened only after investigator approval. Known history of COVID-19 infection within 4 weeks before screening (V1); Known hospitalization due to COVID-19 within 3 months before screening (V1); Subjects who had COVID-19 infection before and who had not recovered sufficiently to participate in clinical trial procedures were screened (V1). 7. Patients receiving long-term oxygen therapy (LTOT) for > 12 hours per day (patients receiving on-demand oxygen therapy (i.e., =12 hours per day) were eligible); 8. Patients requiring continuous positive airway pressure or noninvasive positive pressure ventilation for COPD; 9. Participants who were newly enrolled in the LUNg-rehabilitation program within 4 weeks before visit 1 (acute phase of lung-rehabilitation) or planned to start lung-rehabilitation during the study period (maintenance phase of lung-rehabilitation was eligible); 10. Clinically significant abnormalities on chest computed tomography (CT) that were not considered to be due to COPD. If a chest CT had not been reported within 3 months before visit 1, a chest CT was required at visit 1. 11. Subjects with previous or current uncontrolled clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunologic, gastrointestinal, genitourinary, musculoskeletal, cutaneous, sensory, endocrine disorders, or hematologic abnormalities. Clinically significant was defined as any medical condition that, in the investigator's judgment, might affect the safety of the subject during the course of the study or that, if the condition/disease worsened during the trial, might confound the efficacy or safety analysis; 12. Patients with unstable or life-threatening cardiac disease were excluded if they had any of the following conditions at visit 1: (1) myocardial infarction, unstable angina/acute coronary syndrome, artery bypass grafting (CABG), percutaneous coronary intervention (CPI) in the past 6 months; (2) structural heart disease, such as hypertrophic cardiomyopathy and significant valvu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After 24 weeks, the change of trough FEV1 relative to baseline before administration.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes of FEV1 peak relative to baseline within 3 hours after administration on the first day and the 24 th week.;After 4 weeks, 8 weeks, 12 weeks and 18 weeks, the changes of trough FEV1 before administration relative to baseline were compared.;The changes of chronic obstructive pulmonary disease assessment test ( CAT ) relative to baseline after 24 weeks.;The incidence of moderate to severe acute exacerbation of chronic obstructive pulmonary disease during 24 weeks of treatment.;The changes in the average use of rescue medication during the 24-week treatment period ( number of presses / day ) relative to the baseline and the percentage of days without taking rescue medication.;Incidence and severity of adverse events ( AEs ) and severe adverse events ( SAEs ), as well as abnormal laboratory findings; | — |
Countries
China
Contacts
Public ContactChen Rongchang
Shenzhen People's Hospital
Outcome results
None listed