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

Dong Yang

Status: Invitation-only

Conditions: Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Treatments: Drug: aerosol inhalation of glucocorticoids; Drug: intravenous injection of glucocorticoids

Study type: Interventional

Funder types: Other

Identifiers

NCT06189586

130064

Details and patient eligibility

About

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

Full description

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Nebulized inhalation group

Active Comparator group

Description:

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

Treatment:

Drug: aerosol inhalation of glucocorticoids

Intravenous hormone group

Active Comparator group

Description:

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.

Treatment:

Drug: intravenous injection of glucocorticoids