A Prospective, Randomized, Double-blind, Controlled Multicenter Study of the Efficacy and Safety of Long-term Use of Low-dose Azithromycin in Patients with Chronic Obstructive Pulmonary Disease Combined with Bronchiectasis.
- Conditions
- Chronic Obstructive Pulmonary Disease Combined with Bronchiectasis
- Registration Number
- ChiCTR2400089043
- Lead Sponsor
- Chongqing Bishan District People's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Subjects must meet the following criteria to participate in this study:<br>1) Able to read, understand, and sign the informed consent form;<br>2) Male or female patients aged 40 years and above; <br>3) Meet the diagnostic criteria for COPD as defined by the 2023 GOLD initiative;<br>4) Meet the diagnostic criteria for branch expansion;<br>5) No history of acute exacerbation within 4 weeks prior to enrollment.
Subjects with any of the following conditions will not be eligible to participate in this study:<br>1) Women who are pregnant, lactating, or planning to become pregnant during the study;<br>2) subjects with a current diagnosis of asthma (COPD patients with a history of asthma are also not included in the study);<br>3) Subjects with other respiratory diseases: active tuberculosis, lung cancer, sarcoidosis, pulmonary hypertension, interstitial lung disease, or other active lung diseases;<br>4) Subjects with current clinically significant clinical evidence of neurological, psychiatric, renal, hepatic, immunologic, gastrointestinal, genitourinary, neurological, musculoskeletal, dermatologic, 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 put the subject at risk by participating in the study, or would affect the efficacy or safety analysis if the disease/condition worsened during the course of the study.<br>5) Patients who cannot adhere to the standard treatment of COPD<br>6) History of allergy to any anticholinergic/toxalgic receptor antagonist, ß2 receptor agonist, or history of glaucoma, prostatic hypertrophy or bladder neck obstruction, and in the opinion of the investigator, this is a symptom that is not suitable for participating in the study;<br>7) Poor compliance: subjects who are at risk of non-compliance or unable to comply with study procedures. Severely infirm, disabled, or geographic location that would limit appointments.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of exacerbations;
- Secondary Outcome Measures
Name Time Method COPD Assessment Test;modified Medical Research Council, mMRC;Quality of Life-Bronchiectasis, QoL-B;bronchiectasis severity index, BSI;Pulmonary function ;CT of the chest;electrocardiogram;main symptoms;