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A multicenter, double-blind, randomized, placebo-controlled, non-inferiority study of methylprednisolone 3-day versus 5-day course in the treatment of acute exacerbations of chronic obstructive pulmonary disease

A multicenter, double-blind, randomized, placebo-controlled, non-inferiority study of methylprednisolone 3-day versus 5-day course in the treatment of acute exacerbations of chronic obstructive pulmonary disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064805
Enrollment
Unknown
Registered
2022-10-19
Start date
2022-10-21
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Chronic obstructive pulmonary disease (COPD)

Interventions

Control group:Methadron 40mg/d for 5 consecutive days
Experimental group:Methadron 40mg/d, changed to placebo for 3 consecutive days, for 2 consecutive days

Sponsors

The Affilated Hospitial of Guangdong Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 40-80 years (including 40 and 80 years old), no gender limit; 2. The diagnostic criteria for COPD were met: pulmonary function tests showed persistent airflow limitation, FEV1/FVC<70% after inhalation of bronchodilator, and other diseases causing similar symptoms and persistent airflow limitation were excluded; 3. Acute COPD episodes (defined as acute exacerbation of respiratory symptoms, resulting in the need for additional treatment) without systemic sex hormone therapy; 4. Agree to participate in the study and sign a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Other pulmonary diseases other than COPD, such as asthma, pneumonia, tuberculosis, lung cancer, etc.; 2. Those with a survival period of less than 180 days; 3. The cause of acute exacerbation is not COPD, but other diseases such as heart disease; 4. Patients requiring mechanical ventilation (non-invasive or invasive) or ICU treatment; 5. Systemic fungal infection; 6. Long-term oral or intravenous hormone (prednisone >10 mg/d) or long-term antibiotic therapy is required; 7. Allergic to methylprednisolone; 8. Serious diseases, such as heart failure and malignant tumors, affect research; 9. Patients who have had lung resection; 10. Participating in other clinical researchers within 3 months before enrollment; 11. Patients with immunocompromised diseases such as HIV (AIDS) who have received chemotherapy within 6 weeks prior to randomization and are on immunosuppressive therapy; 12. A history of alcohol or narcotic drug abuse, drug use, or a history of mental illness (e.g., schizophrenia, obsessive-compulsive disorder, depression), antagonistic personality, bad motivation, paranoia, or other emotional or intellectual problems that may affect the informed validity of participation in the study; Mental illness and inability to cooperate with lung function tests; 13. Patients who are pregnant or lactating, or who plan to become pregnant or lactating.

Design outcomes

Primary

MeasureTime frame
Exacerbation rate within 180 days after intervention;

Secondary

MeasureTime frame
Length of Stay;

Countries

China

Contacts

Public ContactLai Tianwen

The Affilated Hospitial of Guangdong Medical University

laitianwen2011@163.com+86 759 2387413

Outcome results

None listed

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