Comparing Hydrocortisone and Prednisolone for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)

Copenhagen Respiratory Research

Status and phase: Begins enrollment in 2 months; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Methylprednisolone (drug); Drug: Hydrocortisone

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT06892210

MineraloCOP

Details and patient eligibility

About

The goal of this cluster randomized controlled trial is to determine the optimal treatment for Acute Exacerbation of Chronic Obstructive Pulmonary Disease. The study compares the effects and side effects of hydrocortisone and prednisolone in patients above 40 years old diagnosed with chronic obstructive pulmonary disease with acute exacerbation. The main question is whether there is a difference in readmission for COPD excerbation or all cause mortality within thirty days.

Participants will randomized to receive treatment with either hydrocortisone or prednisolone.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥40 years
• Chronic obstructive pulmonary disease with acute exacerbation, unspecified: ICDJ44

Exclusion criteria

• All diagnoses that would merit treatment with a specific corticosteroid
• Pregnant or breastfeeding women
• Active tuberculosis or invasive fungal infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,000 participants in 2 patient groups

Treatment with Hydrocortisone.

Active Comparator group

Description:

This arm will recieve a dose of 200 mg of Hydrocortisone intravenously once daily for five days.

Treatment:

Drug: Hydrocortisone

Treatment with Methylprednisolone

Active Comparator group

Description:

This arm will recieve a dose of 40 mg of Methylprednisolone intravenously once daily for five days.

Treatment:

Drug: Methylprednisolone (drug)