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Evaluation of inhaled glucocorticoid and systemic glucocorticoid in acute exacerbation of chronic obstructive pulmonary disease patients with invasive mechanical ventilation

Evaluation of inhaled glucocorticoid and systemic glucocorticoid in acute exacerbation of chronic obstructive pulmonary disease patients with invasive mechanical ventilation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17013192
Enrollment
Unknown
Registered
2017-10-31
Start date
2019-01-01
Completion date
Unknown
Last updated
2017-11-06

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

Systemic glucocorticoid group:Intravenous infusion of methylprednisolone 40mg qd for 5 days + aerosol inhalation placebo (saline 4ml q6h) + aerosol inhalation of bronchodilator (Terbutaline sulfate 5m
Inhaled glucocorticoid group:Aerosol inhalation of budesonide 2mg q6h for 5 days + aerosol inhalation of bronchodilator (Terbutaline sulfate 5mg) + intravenous infusion of placebo (saline 100ml)

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with acute respiratory failure due to acute exacerbation of COPD and treated with invasive mechanical ventilation in ICU; 2. Male or Female aged 40 years or older.;Inclusion criteria: 1. Patients with acute respiratory failure due to acute exacerbation of COPD and treated with invasive mechanical ventilation in ICU; 2. Male or Female aged 40 years or older.;Inclusion criteria: 1. Patients with acute respiratory failure due to acute exacerbation of COPD and treated with invasive mechanical ventilation in ICU; 2. Male or Female aged 40 years or older.;Inclusion criteria: 1. Patients with acute respiratory failure due to acute exacerbation of COPD and treated with invasive mechanical ventilation in ICU; 2. Male or Female aged 40 years or older.;Inclusion criteria: 1. Patients with acute respiratory failure due to acute exacerbation of COPD and treated with invasive mechanical ventilation in ICU; 2. Male or Female aged 40 years or older.

Exclusion criteria

Exclusion criteria: 1. Contraindications with glucocorticoid; 2. Long-term regularly use of systemic glucocorticoid; 3. The equivalent cumulative amount of total glucocorticoid over 250mg of prednisone in the last 2 weeks; 4. Have already treated > 48h or the cumulative dose = 80mg prednisone before entering this study; 5. Combined with other serious respiratory diseases, such as pulmonary fibrosis, pulmonary embolism, pulmonary tumor, etc.;Exclusion criteria: 1. Contraindications with glucocorticoid; 2. Long-term regularly use of systemic glucocorticoid; 3. The equivalent cumulative amount of total glucocorticoid over 250mg of prednisone in the last 2 weeks; 4. Have already treated > 48h or the cumulative dose = 80mg prednisone before entering this study; 5. Combined with other serious respiratory diseases, such as pulmonary fibrosis, pulmonary embolism, pulmonary tumor, etc.;Exclusion criteria: 1. Contraindications with glucocorticoid; 2. Long-term regularly use of systemic glucocorticoid; 3. The equivalent cumulative amount of total glucocorticoid over 250mg of prednisone in the last 2 weeks; 4. Have already treated > 48h or the cumulative dose = 80mg prednisone before entering this study; 5. Combined with other serious respiratory diseases, such as pulmonary fibrosis, pulmonary embolism, pulmonary tumor, etc.;Exclusion criteria: 1. Contraindications with glucocorticoid; 2. Long-term regularly use of systemic glucocorticoid; 3. The equivalent cumulative amount of total glucocorticoid over 250mg of prednisone in the last 2 weeks; 4. Have already treated > 48h or the cumulative dose = 80mg prednisone before entering this study; 5. Combined with other serious respiratory diseases, such as pulmonary fibrosis, pulmonary embolism, pulmonary tumor, etc.;Exclusion criteria: 1. Contraindications with glucocorticoid; 2. Long-term regularly use of systemic glucocorticoid; 3. The equivalent cumulative amount of total glucocorticoid over 250mg of prednisone in the last 2 weeks; 4. Have already treated > 48h or the cumulative dose = 80mg prednisone before entering this study; 5. Combined with other serious respiratory diseases, such as pulmonary fibrosis, pulmonary embolism, pulmonary tumor, etc.

Design outcomes

Primary

MeasureTime frame
Invasive mechanical ventilation free days;

Secondary

MeasureTime frame
Reintubation rates;Mechanical ventilation free days;Length of ICU stay;Length of hospital stay;Hospital mortality;The frequency of acute exacerbation within 1 months after discharge;

Countries

China

Contacts

Public ContactLiang Zongan;Liang Zongan;Liang Zongan;Liang Zongan;Liang Zongan ;;;;

West China Hospital, Sichuan University;West China Hospital, Sichuan University;West China Hospital, Sichuan University;West China Hospital, Sichuan University;West China Hospital, Sichuan University

liangzongan@126.com;liangzongan@126.com;liangzongan@126.com;liangzongan@126.com;liangzongan@126.com+86 028 85422377;+86 028 85422377;+86 028 85422377;+86 028 85422377;+86 028 85422377

Outcome results

None listed

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