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

Not Applicable

• Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease
• Interventions: Drug: intravenous injection of glucocorticoids; Drug: aerosol inhalation of glucocorticoids

• Registration Number: NCT06189586
• Lead Sponsor: Dong Yang

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.

Study Timeline

• Study Start: 2021-10-01
• Status Verified: 2023-12
• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2023-12-19
• Last Update Submitted: 2023-12-19
• Study First Posted: 2024-01-03
• Last Update Posted: 2024-01-03
• Primary Completion: 2024-12-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous hormone group	intravenous injection of glucocorticoids	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.
Nebulized inhalation group	aerosol inhalation of glucocorticoids	2 mg budesonide suspension for inhalation, nebulized inhalation for minutes,administered 4 times a day for 5 consecutive days.

Primary Outcome Measures

Name	Time	Method
Relevant indexes after treatment	The day of admission, day one, day two, day three, day five, day seven, day ten	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

Trial Locations

Locations (1)

The First Hospital of Jilin University; 🇨🇳 Changchun, Ji Lin, China