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

NCT ID: NCT06189586

Last Updated: 2024-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2025-07-31

Brief Summary

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

Detailed Description

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

Conditions

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Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nebulized inhalation group

2 mg budesonide suspension for inhalation, nebulized inhalation for minutes,administered 4 times a day for 5 consecutive days.

Group Type ACTIVE_COMPARATOR

aerosol inhalation of glucocorticoids

Intervention Type DRUG

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 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.

Group Type ACTIVE_COMPARATOR

intravenous injection of glucocorticoids

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jilin University

OTHER

Sponsor Role collaborator

Dong Yang

OTHER

Sponsor Role lead

Responsible Party

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Dong Yang

Assisted Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dan Li, Doctor

Role: STUDY_DIRECTOR

The First Hospital of Jilin University

Locations

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The First Hospital of Jilin University

Changchun, Jilin, China

Site Status

Countries

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China

Other Identifiers

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130064

Identifier Type: -

Identifier Source: org_study_id

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