COPD
Conditions
Interventions
placebo group:Placebo bid Oral
treatment group:N-acetylcysteine 600 mg bid orally
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) able to read, understand, and sign an informed consent form; 2) male or female outpatients or inpatients aged 40 years and older; 3) have completed a chest CT and pulmonary function test; and 4) meet the diagnostic criteria and phenotypic subgroups of Pre-COPD, as defined by the 2023 edition of the GOLD Initiative;
Exclusion criteria
Exclusion criteria: 1) Women who are pregnant, breastfeeding, or planning to become pregnant during the study period; 2) Subjects with a current diagnosis of chronic obstructive pulmonary disease (COPD) or a diagnosis of asthma; 3) Subjects with a combination of other respiratory diseases: active tuberculosis, lung cancer, a combination of bronchiectasis, tuberculosis, pulmonary fibrosis, pulmonary arterial hypertension, interstitial lung disease, or other active lung disease prior to the initial diagnosis of COPD; 4) Subjects with a current incurable respiratory infection (pneumonia, lung abscess, etc.); 5) Subjects with current clinical evidence of clinically significant neurologic, psychiatric, renal, hepatic, immunologic, gastrointestinal, genitourinary, neurologic, musculoskeletal, cutaneous, sensory, endocrine (including uncontrolled diabetes mellitus or thyroid disease), or hematologic abnormalities. Significance is defined as any disease that, in the opinion of the investigator, would place the subject at risk by participation in the study, or that would interfere with the efficacy or safety analysis if the disease/condition were to worsen during the course of the study. 6) History of allergy to any anticholinergic/toxicotoxin receptor antagonist, beta2 agonist, or history of glaucoma, prostatic hypertrophy, or bladder neck obstruction that, in the opinion of the investigator, is a symptom that makes participation in the study inadvisable; 7) Poor adherence:Subjects at risk of nonadherence or unable to comply with study procedures. Severe physical infirmity, disability, or geographic location will limit access to appointments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acute exacerbation;mortality rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Annual hospitalization rate;Decreased lung function value;Clinical symptom score; | — |
Countries
China
Contacts
Public ContactDan Wang
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed