Post-tuberculosis COPD
Conditions
Interventions
Control Group:As-needed inhaled salbutamol therapy
Intervention Group:As needed inhaled salbutamol treatment + regular inhalation of glycopyrrolate formoterol inhalation aerosol
Sponsors
Guangzhou Chest Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age 20-80, male or female, smoking < 10 packs* years; 2.Patients with a history of pulmonary tuberculosis and imaging findings but not currently receiving long-term anti-tuberculosis treatment; 3.post-bronchodilator, FEV1/FVC < 0.70 and FEV1 = 50% predicted value; 4.The diagnosis time of pulmonary tuberculosis is earlier than that of chronic obstructive pulmonary disease; 5.The subject is in a stable period, that is, no acute exacerbation has occurred in the past 4 weeks; 6.No regular use of long-acting bronchodilators in the past month; 7.The subjects are able to communicate verbally or in writing and sign the informed consent form; 8.The subjects agree and are able to complete the auxiliary examinations related to the trial;
Exclusion criteria
Exclusion criteria: 1.Major illness. Major illness is defined as any disease or condition that, in the judgment of the investigator, may put the subject at risk for participating in the trial or may affect the trial results or the subject's ability to participate in the trial. 2.Clinical diagnosis of lung cancer, bronchiectasis, pneumoconiosis, asthma, interstitial lung disease or other serious lung diseases; 3.Serious heart, brain, liver, kidney, blood system diseases or malignant tumors, etc. 4.Clinically significant abnormalities in baseline blood routine, blood biochemistry or urine analysis, and major diseases defined in exclusion criteria 1; 5.Patients with known moderate to severe renal impairment or creatinine clearance = 50 ml/m; 6.Active pulmonary tuberculosis; 7.Patients with life-threatening pulmonary embolism, alpha-1 antitrypsin deficiency, or cystic fibrosis; 8.Patients who have undergone lung resection; 9.Acute exacerbation within 4 weeks prior to the first visit or requiring hospitalization and/or antibiotic treatment and/or oral or intravenous steroids during the enrollment period; 10.Regular use of long-acting bronchodilators in the past month; 11.Patients who require long-term oxygen therapy, long-term use of steroids (oral or intravenous), or long-term use of antibiotics; 12.Women who are pregnant, breastfeeding or may become pregnant; 13.Patients with a history of allergy or intolerance to the trial drug; 14.A history of chronic alcoholism, drug abuse, or any factors that may affect compliance; 15.Patients who are currently participating in clinical trials of other drugs; 16.COPD was diagnosed earlier than TB, or both were diagnosed at the same time; 17.Those who have been diagnosed with mental illness; 18.Those who have used biofuels for cooking or heating for more than 12 months;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences between groups in the change in pre-bronchodilator FEV1 compared with baseline after 12 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Between-group differences in rescue medication;Time from treatment to first acute exacerbation;Incidence of acute exacerbations (total acute exacerbations, moderate and severe acute exacerbations);The difference between the two groups in the change of symptom scores (mMRC, CAT) compared with the baseline after 12 weeks of treatment;Between-group differences in the change in FEV1 after inhaled bronchodilator therapy compared with baseline after 12 weeks of treatment;Differences between groups in the annual decline rates of FEV1, FVC, FEV1/FVC, FEV3/FVC, FEV3/FEV6, MMEF, FEF50, and FEF75 before and after inhalation of bronchodilators;The proportion of subjects whose CAT score improved by 2 points or more;Differences in the percentage of predicted FEV1, FVC, percentage of predicted FVC, FEV1/FVC, FEV3/FVC, FEV3/FEV6, MMEF, FEF50, and FEF75 between the groups;Differences in dropout rates between groups; | — |
Countries
China
Contacts
Public ContactWeifeng Zou
Guangzhou Chest Hospital
Outcome results
None listed