Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Carbocysteine group:Oral carbocysteine tablets (500 mg three times a day)
Placebo group:Oral placebo (three times a day)
Sponsors
The First Affiliated Hospital of Guangzhou Medical University/Guangzhou National Laboratory
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: ?Age 20-80 years old, male or female, current smoker or quitter with a smoking volume of =10 packs*years; ?FEV1/FVC =0.70 after inhalation of bronchodilator; ?SGRQ score defines chronic bronchitis (SGRQ cough item selects "most of the time in a week" or "a few days in a week" + SGRQ sputum item selects "most of the time in a week" or "a few days in a week"); ?The subject is in a stable period, that is, no acute respiratory events/acute exacerbations have occurred in the past 4 weeks; ?The subject is able to communicate verbally or in writing and sign the informed consent form; ?The subject agrees and is able to complete the auxiliary examinations related to the trial.
Exclusion criteria
Exclusion criteria: ?Severe illness. A major disease is defined as: a disease or condition that, according to the researcher's judgment, may put the subject at risk because of participation in the trial, or affect the trial results or the subject's ability to participate in the trial; ? Clinical diagnosis of lung cancer, bronchiectasis, pneumoconiosis, asthma, interstitial lung disease or other serious lung diseases; ?Severe heart, brain, liver, kidney, blood system diseases or malignant tumors; ? There are clinically significant abnormalities in baseline blood routine, blood biochemistry or urinalysis, and meet the major diseases defined in exclusion criterion 1; ?Those with known moderate to severe renal impairment, judged by the researcher or the creatinine clearance rate is =50ml/min; ?Currently suffering from active pulmonary tuberculosis; ?Patients with life-threatening pulmonary embolism, alpha-1 antitrypsin deficiency, or cystic fibrosis; ?Patients who have undergone lung resection; ?Have acute respiratory events/acute exacerbations within 4 weeks before the first visit, or require hospitalization and/or antibiotic treatment and/or oral or intravenous steroid treatment during the inclusion period. ?Patients who require long-term use of oxygen therapy, long-term use of (oral or intravenous) hormones, or long-term use of antibiotics; ?Women who are pregnant, breastfeeding or may be pregnant; ?Patients with a history of allergies or intolerance to the trial drugs; ?Have a history of chronic alcoholism, drug abuse, or any factors that affect compliance; ?Patients who are participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of acute respiratory events (acute exacerbations); | — |
Secondary
| Measure | Time frame |
|---|---|
| SGRQ score;Risk of progression to spirometric COPD (post-bronchodilator FEV1/FVC < 0.70) after 12 months of treatment;Differences in the annual decline rates of prebronchodilator and postbronchodilator lung function FEV1, FVC, FEV1/FVC, MMEF, FEF50, and FEF75 between groups;mMRC score;CAT score;The proportion of subjects whose SGRQ score improved by 4 points or more after 12 months of treatment;The incidence rate of the composite endpoint (COPD development, moderate-to-severe acute respiratory events/acute exacerbations, annual decrease in FEV1 trough value = 100 ml, and increase in SGRQ = 4 points) after 12 months of treatment;Proportion of subjects whose CAT score improved by 2 points or more after 12 months of treatment;Differences in CT emphysema, gas trapping, and airway remodeling between groups and differences in changes from baseline at 12 months after treatment;Differences in impulse oscillometry defined small airway dysfunction changes from baseline between groups after 12 months of treatment;Differences in lung diffusion function and changes from baseline between groups after 12 months of treatment;Time to the first acute respiratory events (acute exacerbations);Incidence of moderate-to-severe acute respiratory events (acute exacerbations);Risk of progression to spirometric COPD (post-bronchodilator FEV1/FVC < LLN) after 12 months of treatment;The between-group difference in the change from baseline to 12 months in the FEV1, FVC, FEV1/FVC, MMEF, FEF50 , FEF75 before and after bronchodilator use.;The between-group difference in the change from baseline to 12 months in the lung diffusion function;The between-group difference in the change from baseline to 12 months in the six-minute walk test;Rescue medication;Dropout rate;Cost-effectiveness analysis; | — |
Countries
China
Contacts
Public ContactYumin Zhou
The First Affiliated Hospital of Guangzhou Medical University/Guangzhou National Laboratory
Outcome results
None listed