Chronic obstructive pulmonary disease
Conditions
Interventions
Phase 1:Experimental group:Compound ipratropium bromide solution for inhalation, administered twice daily, once in the morning and once in the evening
Phase 1:Control group:Normal saline, administered twice daily, once in the morning and once in the evening
Phase 2:Experimental group:Compound ipratropium bromide solution for inhalation, administered twice daily, once in the morning and once in the evening
Phase 2:Control group:Blank control, no medication used.
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Screening period (1) Patients aged 40 to 75 years (including 40 and 75 years) who meet the diagnosis of COPD, regardless of gender; (2) COPD patients are in stable phase (the patient has not experienced AECOPD within 4 consecutive weeks before screening); (3) Post bronchodilator (15-30 minutes after inhalation of 400 µg of salbutamol) FEV1/FVC= 50% of the predicted value; (4) Those who voluntarily participate and sign the informed consent form, the process of obtaining the informed consent form conforms to GCP; (5) Tolerating aerosol inhalation therapy; (6) After guidance, the patient can correctly use the nebulizer and relieve drug treatment, and fill in the diary card correctly. 2. Before Treatment (1) Stable COPD condition during the screening period, with no acute exacerbations of COPD (AECOPD) or acute respiratory infections. (2) Adherence to completing the diary card reports exceeding 80% during the screening period. (3) No use of prohibited medications during the screening period. (4) The investigator deems the subject suitable for participation in the clinical trial. Special Instructions of Inclusion and Exclusion Criteria: 1) Definition of Screening Period: 14 ± 2 days prior to randomization. 2) Definition of Treatment Period: Phase 1: Eligible subjects are randomly assigned to either the experimental group or placebo group and receive nebulized inhalation treatment twice daily for 48 weeks. Phase 2: Subjects from the experimental group who complete Phase 1 are re-randomized to either the experimental group or blank control group and continue treatment for an additional 48 weeks. 3) Relationship Between Screening Period and Treatment Period: The inclusion and exclusion criteria during the screening period are applied for initial subject selection. Subjects who satisfy all screening inclusion criteria and none of the exclusion criteria may proceed to randomization if they continue to meet the inclusion criteria (before treatment) following the screening period.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to ipratropium bromide or salbutamol; 2. Combined with important diseases other than COPD. Important disease is defined as: the investigator believes that the combination of a disease or the severity of the disease may cause the patient to participate in the study and put it at risk, or may affect the results of the study, or significantly affect the patient's ability to participate in the study; 3. Patients with significant clinical abnormalities in laboratory tests (such as blood routine, blood biochemistry, and urine routine), if they are abnormal, they are defined as important diseases in exclusion criteria 2; 4. Combined with clinically significant pneumoconiosis and other restrictive ventilation diseases; 5. Combined malignant tumor; 6. Combined with clinically significant prostatic hyperplasia or bladder neck obstruction, or narrow-angle glaucoma; 7. Patients with known moderate to severe renal impairment (serum creatinine > 178umol/L); 8. Combined with a history of asthma, allergic rhinitis or known patients with blood eosinophil count >= 600/mm^3; 9. Combined with active pulmonary tuberculosis; 10. Patients with life-threatening pulmonary embolism, clinically significant a1-antitrypsin deficiency or cystic fibrosis; 11. A history of lung resection; 12. Requires hospitalization, and/or antibiotics, and/or oral or intravenous glucocorticoids during the screening phase; 13. Long-term oxygen therapy (>12 hours per day for more than 30 days), long-term oral or intravenous glucocorticoid therapy, or long-term antibiotic therapy; 14. Patients who the investigator considers unsuitable to participate in clinical research; 15. Women who are breastfeeding, pregnant or planning to become pregnant (women of childbearing age must use effective contraception during the study period); 16. Participated in other clinical trials within 3 months before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in trough FEV1 at Week 48; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in peak FEV1 (2 hours post-dose) at Weeks 4, 24, 48, 72, and 96;Change from baseline in trough FEV1 at Weeks 4, 24, 72, and 96;Change from baseline in MMEF, MEF50%, and MEF25% at Weeks 4, 24, 48, 72, and 96;Change from baseline in quality of life scores (CAT and CCQ) at Weeks 4, 12, 24, 36, 48, 60, 72, and 96;Change from baseline in symptom scores (mMRC) at Weeks 4, 12, 24, 36, 48, 60, 72, and 96;Time to first COPD exacerbation within 48 weeks and between Weeks 52-96;Number of COPD exacerbations within 96 weeks;Difference in rescue medication use within 96 weeks;Annual decline in trough FEV1 from Week 4 to Week 96;Annual decline in peak FEV1 (2 hours post-dose) from Week 4 to Week 96;Annual decline in trough FVC from Week 4 to Week 96;Annual decline in peak FVC (2 hours post-dose) from Week 4 to Week 96;Annual decline rate in trough FEV1/FVC from Week 4 to Week 96;Annual decline rate in peak FEV1/FVC (2 hours post-dose) from Week 4 to Week 96;Percentage of post-bronchodilator FEV1/FVC >0.7 at Week 48;Change from baseline in PRM_Emph and PRM_GasTrap at Week 48; | — |
Countries
China
Contacts
Public ContactZhong Nanshan
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed