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Clinical study of fudosteine in patients with stable COPD of neutrophil type

Clinical study of fudosteine in patients with stable COPD of neutrophil type

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039900
Enrollment
Unknown
Registered
2020-11-14
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-02-22

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

Conditions

COPD

Interventions

control group:regular treatment + placebo
treatment group:regular treatment + fudosteine

Sponsors

Zhongshan Hospital Affiliated Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients over 18 years old who were diagnosed with COPD at a stable stage according to the 2011 edition of Guidelines for diagnosis and Treatment of Chronic Obstructive Pulmonary Disease formulated by the Ministry of Health; (2) Pulmonary function grades of COPD patients were diagnosed as grade 2 and grade 3 according to the 2011 GOLD Guidelines; (3) Informed consent of prospective researchers, with good cooperation and compliance, without reading, writing or communication barriers; (4) The patient has been living around the city for a long time, which is convenient for the medical unit to follow up the patient and prevent the patients from falling off; (5) Previous studies judged it as neutrophil type COPD (the proportion of neutrophils in induced sputum was greater than 60% and the proportion of eosinophils was less than 3%).

Exclusion criteria

Exclusion criteria: (1) Combined with untreated pneumothorax, tympanic membrane rupture or other middle ear lesions, pulmonary hypertension, active hemoptysis and other diseases; (2) Recent oral or facial or skull surgery or injury; (3) Intracranial pressure higher than 20mmHg; (4) Complicated with systemic infection or autoimmune disease; (5) Simple asthma complicated with giant pulmonary bullae, diffuse bronchiolitis or serious lesions of heart, liver, kidney and other important organs; (6) The disease was unstable and AE appeared frequently in the first 3 months before enrollment.

Design outcomes

Primary

MeasureTime frame
blood routine examination;pulmonary function;IgE in blood;chest CT;Questionnaire score;induced sputum;medical history;

Countries

China

Contacts

Public ContactChen Zhihong

Zhongshan Hospital Affiliated Fudan University

chen.zhihong@zs-hospital.sh.cn+86 13764520650

Outcome results

None listed

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