Chronic Obstructive Pulmonary Disease
Conditions
Interventions
N-acetylcysteine effervescent tablets:N-acetylcysteine effervescent tablets
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 40-80 years old, male or female, community or outpatient. 2. Has a respiratory symptoms(Chronic cough, sputum, shortness of breath) and/or chronic obstructive pulmonary exposure risk factors (smoking, occupational exposure, indoor and outdoor air pollution, family history of chronic obstructive pulmonary disease, recurrent respiratory tract infection, low birth weight, And genetic factors, etc); 3. GOLD stage I-II, COPD: FEV1/FVC<70% and FEV1=50% predicted after 20minutes with 400µg of salbutamol inhalation; 4. Patients in a stable period, that is, near 4 weeks without COPD acute exacerbations; 5. The patient is able to communicate in words or words,agrees and has the ability to complete the test-related auxiliary examination.Sign informed consent.
Exclusion criteria
Exclusion criteria: 1. In addition to COPD outside the major diseases. The definition of a major disease is defined as a disease or condition that participates in a trial that allows the patient to be at risk or affect the outcome of the trial or the patient's ability to participate in the trial; 2. Baseline blood, blood biochemistry, or urine analysis has clinically significant abnormalities, and this abnormality is a major disease defined in Standard 1; 3. Clinical diagnosis of lung cancer, pneumoconiosis, bronchiectasis, interstitial lung disease, bronchial asthma or other simple restrictive ventilation dysfunction; 4. Severe heart, brain, liver, kidney, blood system diseases or malignant tumors, etc., affect the study completed; 5. Known to moderate to severe renal impairment, the researchers to determine or creatinine clearance rate = 50ml / min; 6. Patients with phenylketonuria; 7. Patients with allergic history or intolerance to the test drug; 8. Suffering from severe gastric ulcer patients or small intestine malabsorption; 9. Now suffering from active tuberculosis; 10. Life-threatening pulmonary embolism, or alpha1-antitrypsin deficiency, or cystic fibrosis; 11. Patients who had undergone pneumonectomy; 12. Pediatric, pregnant, or would be pregnant, breastfeeding; 13. Excessive COPD was exacerbated within 4 weeks prior to the first visit (V0), or hospitalization and/or antibiotic treatment and/or oral or intravenous therapy were required during the enrollment; 14. Those who receive NAC for more than 3 months; 15. Need long-term use of inhaled glucocorticoids, systemic (oral or intravenous) hormone dose instability (ie, dose stabilization time is less than 6 weeks) or hormone dose exceeds the equivalent of prednisone 10mg/d, or long-term use of antibiotics; 16. Patients planned to be admitted during the trial (affect the trial investigator) or need to plan a transplant within 2 years; 17. Have chronic alcohol abuse, drug abuse, or any factors that affect compliance; 18. The patient is currently participating in other clinical trials; 19. The next two years to receive long-term use of oxygen therapy, rehabilitation treatment of patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment of the FEV1 valley and peak at 24 months;treatment of the number of acute exacerbations COPD within 24 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment of FEV1, FVC, FEV1 / FVC valleys and peak values at 12 months and 24 months;The annual rate of decline in lung function FEV1, FVC, FEV1 / FVC (valley and peak) during treatment;Quality of Life (CAT);Symptom score;Acute exacerbation COPD of the interval and duration;COPD acute exacerbation severity;Adverse events;Drop rate; | — |
Countries
China
Contacts
Public ContactPixin Ran
Guangzhou Medical University
Outcome results
None listed