Chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
Group 1:B, F, D(B: 261 µ g/141 µ GHL231 inhalation solution
D: Jierun Ultibro µ g/50 µ g)
F: 261 µ g/120 µ G HL23 l inhalation solution)
Group 2:D?B?F(B: 261 µ g/141 µ GHL231 inhalation solution
Group 3:F?D?B(B: 261 µ g/141 µ GHL231 inhalation solution
Group 4:D?F?B(B: 261 µ g/141 µ GHL231 inhalation solution
Group 5:F?B?D(B: 261 µ g/141 µ GHL231 inhalation solution
Group 6:B?D?F(B: 261 µ g/141 µ GHL231 inhalation solution
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) At the screening visit (Visit 1), outpatients aged =40 years old, male or female; 2) Patients diagnosed with chronic obstructive pulmonary disease (COPD) according to GOLD criteria; 3) Smoking volume = 10 pack-years (smoking index (pack-year) = daily smoking volume (pack) × time (year), 1 pack = 20 sticks) Current smokers or ex-smokers (eg: at least 1 pack/day for 10 years), or having a history of biofuel exposure; 4) At the screening visit (Visit 1), forced expiratory volume (FEV1)/forced vital capacity (FVC) in the first second after inhalation of bronchodilator <0.7; 30% expected value = FEV1 after inhalation of bronchodilator < 80% of expected value (after inhalation of bronchodilator refers to 1 hour after sequential inhalation of 84 µg (or equivalent dose) ipratropium bromide and 400 µg albuterol Time); 5) At the screening visit (visit 1), FEV1 improved by = 12% after inhalation of bronchodilators; 6) At the screening visit (visit 1), the patient's mMRC score was =2; 7) Patients who are able to cooperate with the completion of pulmonary function tests after training (acceptability and repeatability are in line with ATS/ERS standards); 8) Before participating in this study, no regular COPD treatment; or during the screening lead-in period and treatment Deactivation scheme Prohibited medications for COPD (except albuterol sulfate inhalation aerosol as a rescue medication). 9) Tolerance of nebulized inhalation therapy, after guidance, patients can correctly use nebulizers, inhaled powder mist and relief drugs treatment, correctly fill out the diary card; 10) Not participated in other interventional clinical research or pulmonary disease rehabilitation projects that may affect the results of this study in the past 4 weeks; 11) Voluntarily signed an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Suffering from other diagnosed clinically significant respiratory diseases other than COPD, including but not limited to: a-1 antitrypsin deficiency, cystic fibrosis, severe asthma (significant asthma), active bronchiectasis (active bronchiectasis), bronchiolitis obliterans, active pulmonary tuberculosis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, pulmonary edema, pulmonary interstitial disease, other active lung diseases and lung cancer patients; 2) Other cardiovascular diseases with clinical significance (such as: unstable ischemic heart disease, congestive heart failure, uncontrolled hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg, whether or not antihypertensive therapy is used) ), uncontrolled coronary artery disease, myocardial infarction, arrhythmia, history of long QT syndrome or QTc prolongation (QTcF interval>450ms, corrected by Fridericia's formula), paroxysmal atrial fibrillation), renal, neurological, endocrine, immune , Mental, gastrointestinal, liver or blood system disease/abnormal history, the investigator believes that if the disease is aggravated during the trial, it may be risky to the patient or affect the analysis of the research results; 3) Suffering from paradoxical bronchospasm, angle-closure glaucoma, symptomatic benign prostatic hyperplasia (except for patients with stable prostatic hyperplasia), bladder neck obstruction, or severe renal injury or urinary retention or any other contraindication of anticholinergic drugs in the opinion of the investigator medical history; 4) Suffering from cancer (except for patients with cervical cancer in situ, skin squamous cell carcinoma and basal cell carcinoma who have been cured for more than 5 years); 5) History of allergy to anticholinergic/muscarinic receptor antagonist drugs, long-acting or short-acting ß2 adrenoceptor agonists, sympathomimetic amines, lactose/milk protein (dairy products) intolerance, Hypersensitivity to indacaterol, glycopyrronium bromide, or any known ingredient in the drug delivery system; 6) Hospitalized for COPD or pneumonia within 12 weeks before screening (Visit 1); 7) Treatment for acute exacerbation of COPD (antibiotics, systemic glucocorticoids) within 12 weeks before screening (Visit 1) medical treatment, hospitalization or emergency treatment, etc.); 8) Within 3 years before screening, the average number of acute exacerbations of moderate to severe COPD = 2 times/year; 9) At screening (visit 1), blood eosinophils > 600/mm3; 10) Any prohibited drugs were used before pulmonary function test of the screening (Visit 1); 11) Acute (viral or bacterial) upper or lower respiratory tract infection, sinusitis, pharyngitis, urinary tract infection, etc. within 6 weeks prior to screening (Visit 1); patients with respiratory infection after screening and before treatment will be cannot participate in the study, but re-screening is allowed 6 weeks after respiratory infection resolves; 12) During the screening lead-in period, the 12-lead electrocardiogram appears to be of clinical significance as judged by the investigator that it may be risky to the patient the exception; 13) Having received lobectomy or lung volume reduction surgery within 12 months before the start of the study; 14) Patients who need to receive long-term oxygen therapy for more than 12 hours a day; 15) Clinically significant apnea requiring the use of a continuous positive airway pressure (CPAP) device or a noni
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lung function test;Safety assessment;Pharmacokinetics;Pharmacodynamics; | — |
Countries
China
Contacts
Public ContactZhu Luo
West China Hospital, Sichuan University
Outcome results
None listed