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

Phase 4

Not yet recruiting

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: Hydrocortisone; Drug: Methylprednisolone (drug)

• Registration Number: NCT06892210
• Lead Sponsor: Copenhagen Respiratory Research

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-18
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-30
• Study Start: 2025-08-01
• Primary Completion: 2026-08-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment with Hydrocortisone.	Hydrocortisone	This arm will recieve a dose of 200 mg of Hydrocortisone intravenously once daily for five days.
Treatment with Methylprednisolone	Methylprednisolone (drug)	This arm will recieve a dose of 40 mg of Methylprednisolone intravenously once daily for five days.

Primary Outcome Measures

Name	Time	Method
Readmission for COPD exacerbation or death from all causes	30 days

Secondary Outcome Measures

Name	Time	Method
Days alive and out of hospital	14 days
Mortality	90 days
Readmission for COPD exacerbation	90 days
All-cause infections	90 days	Defined as a new prescription of antibacterial medication.
Need for mechanical ventilation	30 days
New onset infections	30 days
Daily amount of insulin administered to the patient by day 7 or discharge from hospital	7 days
Gastrointestinal bleeding	30 days
Blood glucose levels	7 days	Measured at day 3 and day 7