Skip to content

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.

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.

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089043
Enrollment
Unknown
Registered
2024-08-30
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease Combined with Bronchiectasis

Interventions

Placebo group:Patients with COPD who are in the stable phase of using inhaled preparations according to the GOLD2023 and are treated with oral placebo for 1 year.
Azithromycin combination regimen group:According to the GOLD2023 standardized use of inhaled preparations, patients in the stable phase with COPD with branch expansion were given oral azithromycin cap

Sponsors

Chongqing Bishan District People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: Subjects must meet the following criteria to participate in this study: 1) Able to read, understand, and sign the informed consent form; 2) Male or female patients aged 40 years and above; 3) Meet the diagnostic criteria for COPD as defined by the 2023 GOLD initiative; 4) Meet the diagnostic criteria for branch expansion; 5) No history of acute exacerbation within 4 weeks prior to enrollment.

Exclusion criteria

Exclusion criteria: Subjects with any of the following conditions will not be eligible to participate in this study: 1) Women who are pregnant, lactating, or planning to become pregnant during the study; 2) subjects with a current diagnosis of asthma (COPD patients with a history of asthma are also not included in the study); 3) Subjects with other respiratory diseases: active tuberculosis, lung cancer, sarcoidosis, pulmonary hypertension, interstitial lung disease, or other active lung diseases; 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. 5) Patients who cannot adhere to the standard treatment of COPD 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; 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.

Design outcomes

Primary

MeasureTime frame
Number of exacerbations;

Secondary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactLiu Bicui

Chongqing Bishan District People's Hospital

27264224@qq.com+86 135 9421 9120

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026