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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06189586
Enrollment
100
Registered
2024-01-03
Start date
2021-10-01
Completion date
2025-07-31
Last updated
2024-01-03

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

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Keywords

severe AECOPD, aerosol inhalation and intravenous glucocorticoid

Brief summary

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

Detailed description

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

Interventions

DRUGaerosol 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

DRUGintravenous 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

Sponsors

Jilin University
CollaboratorOTHER
Dong Yang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Description for medicine or protocol of treatment in detail: Dosing regimen: 1. Intravenous hormone group: 40mg sodium methylprednisolone succinate for injection(dissolved in 0.9% saline or5% glucose injection 50ml), intravenous infusion for 30 minutes, once a day for 5 consecutive days. 2. Nebulized inhalation group: 2 mg budesonide suspension for inhalation, nebulized inhalation for minutes,administered 4 times a day for 5 consecutive days.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Relevant indexes after treatmentThe day of admission, day one, day two, day three, day five, day seven, day tenChanges in blood gas indexes (oxygenation index, arterial partial pressure of carbon dioxide, pH value) of patients with respiratory rate, blood pressure, heart rate changes

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026