Comparison of Aerosol Inhalation and Intravenous Glucocorticoid in the Treatment of Severe AECOPD

Acute Exacerbation of Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Comparison of Aerosol Inhalation and Intravenous Glucocorticoid in the Treatment of Severe AECOPD-------Multicenter, Prospective, Randomized, Controlled Clinical Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06189586
• Other study ID #: 130064
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: July 31, 2025

Study information

• Verified date: December 2023
• Source: Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison of aerosol inhalation and intravenous glucocorticoid in the treatment of severe AECOPD-------Multicenter, prospective, randomized, controlled clinical study

Description:

This study aims to compare the efficacy and comprehensive benefits of aerosol inhalation and intravenous injection of glucocorticoids in severe AECOPD patients.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: July 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

(1) Patients with AECOPD requiring hospitalization or emergency treatment (COPD acute attacks combined with respiratory failure were eligible). (2) 18 years of age =80 years of age (3) Patients and their families are willing to participate in clinical research and sign informed consent.

Exclusion Criteria:

1. Combined with tuberculosis.

2. Combined bronchiectasis.

3. complicated with definite infectious diseases.

4. PCT=0.5ng/ml or CRP=30mg/L.

5. Serious injury combined with other organ functions

6. Contraindications to other glucocorticoid use.

7. Concomitant bronchial asthma or positive bronchodilation test

Related Conditions & MeSH terms

• Acute Exacerbation of Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Aspiration

Intervention

Drug:
• aerosol inhalation of glucocorticoids
Patients with severe AECOPD were continuously recruited from the care unit of Respiratory and Critical Care Medicine Department of the First Hospital of Jilin University to conduct a randomized cohort study, which was divided into aerosol inhalation group and intravenous glucocorticoid group. Subjects in the intravenous hormone group received 40mg methylprednisolone (dissolved in 0.9% normal saline /5% glucose injection 50ml) intravenously once a day. It lasts for 5 days. The atomized inhalation
• intravenous injection of glucocorticoids
Patients with severe AECOPD were continuously recruited from the care unit of Respiratory and Critical Care Medicine Department of the First Hospital of Jilin University to conduct a randomized cohort study, which was divided into aerosol inhalation group and intravenous glucocorticoid group. Subjects in the intravenous hormone group received 40mg methylprednisolone (dissolved in 0.9% normal saline /5% glucose injection 50ml) intravenously once a day. It lasts for 5 days. The atomized inhalation

Locations

Country	Name	City	State
China	The First Hospital of Jilin University	Changchun	Ji Lin

Sponsors (2)

Lead Sponsor	Collaborator
Dong Yang	Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relevant indexes after treatment	Changes in blood gas indexes (oxygenation index, arterial partial pressure of carbon dioxide, pH value) of patients with respiratory rate, blood pressure, heart rate changes	The day of admission, day one, day two, day three, day five, day seven, day ten