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Effects of glucocorticoids on airway microecology in patients with acute exacerbation of Chronic Obstructive Pulmonary Disease: a randomized controlled study

Effects of glucocorticoids on airway microecology in patients with acute exacerbation of Chronic Obstructive Pulmonary Disease: a randomized controlled study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038238
Enrollment
Unknown
Registered
2020-09-15
Start date
2020-10-08
Completion date
Unknown
Last updated
2020-12-07

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

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Short-term treatment group:Oral corticosteroids for 5 days
Long-term treatment group:Oral corticosteroids for 10 days

Sponsors

The First Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age: 40-80 years old patients, male and female, outpatient or inpatient cases; 2. Patients with COPD meeting gold 2020 diagnostic criteria; 3. Patients with one respiratory symptom (chronic cough, expectoration, shortness of breath); 4. In patients with acute exacerbation: the dyspnea, cough and / or expectoration of COPD patients showed acute changes at the basic level, which exceeded the daily variation every day, and needed to change treatment; 5. A patient who is able to communicate in language or writing. Sign informed consent. 6. Patients who agree and have the ability to complete the auxiliary examination related to the trial.

Exclusion criteria

Exclusion criteria: 1. Patients with major diseases other than COPD. The definition of major disease is as follows: according to the judgment of the researcher, because participation in the trial may put the patient at risk, affect the test results or the ability of the patient to participate in the trial; 2. Patients with clinically significant abnormal blood routine, blood biochemistry or urine analysis at baseline; 3. Clinical diagnosis of lung cancer, pneumoconiosis, bronchiectasis, interstitial lung disease, bronchial asthma or other simple restrictive ventilation dysfunction; 4. Severe heart disease (heart failure, QT interval prolongation, arrhythmia), brain, liver, kidney, blood system diseases or malignant tumor, etc., which affect the study completion; 5. Antibiotics and / or oral or intravenous hormone therapy were used one month before enrollment; 6. Patients with severe acute exacerbation of COPD need invasive mechanical ventilation or ICU treatment, and are expected to be unable to discharge in a short time; 7. Patients with severe gastric ulcer or intestinal malabsorption; 8. Patients with active pulmonary tuberculosis or life-threatening pulmonary embolism, a 1-antitrypsin deficiency or cystic fibrosis; 9. Female patients in pregnancy and lactation period; 10. Patients who have undergone pneumonectomy or need to plan transplantation within 2 years; 11. Patients with a history of chronic alcoholism, drug abuse, or any factors affecting compliance; 12. Patients currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Sputum microecology;

Countries

China

Contacts

Public ContactZhiyi He

The First Hospital of Guangxi Medical University

zhiyi-river@163.com+86 18778017698+86

Outcome results

None listed

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