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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: Methylprednisolone (drug); Drug: Hydrocortisone

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jens-Ulrik Stæhr Jensen, MD, PHD; Phone Number: +45 38673057; Email: jens.ulrik.jensen@regionh.dk
• Study Contact Backup: Name: Pradeesh Sivapalan, MD, PHD; Phone Number: +45 29880601; Email: pradeesh.sivapalan.02@regionh.dk

Study Locations

• Denmark
  • Bornholm
    • Rønne, Bornholm, Denmark, 3700
      • Recruiting
      • Bornholm Hospital
  • Copenhagen City
    • Copenhagen, Copenhagen City, Denmark, 2300
      • Recruiting
      • Amager Hospital
    • Copenhagen, Copenhagen City, Denmark, 2400
      • Recruiting
      • Bispebjerg Hospital
    • Frederiksberg, Copenhagen City, Denmark, 2000
      • Recruiting
      • Frederiksberg Hospital
    • Hellerup, Copenhagen City, Denmark, 2900
      • Recruiting
      • Gentofte Hospital
  • Copnhagen Surroundings
    • Herlev, Copnhagen Surroundings, Denmark, 2730
      • Recruiting
      • Herlev Hospital
    • Hvidovre, Copnhagen Surroundings, Denmark, 2650
      • Recruiting
      • Hvidovre Hospital
  • North Zealand
    • Hillerød, North Zealand, Denmark, 3400
      • Recruiting
      • Nordsjællands Hospital
  • Region Sjælland
    • Holbæk, Region Sjælland, Denmark, 4300
      • Recruiting
      • Holbæk Sygehus
    • Køge, Region Sjælland, Denmark, 4600
      • Recruiting
      • University Hospital of Region Zealand, Køge
    • Næstved, Region Sjælland, Denmark, 4700
      • Recruiting
      • Næstved Sygehus
    • Ringsted, Region Sjælland, Denmark, 4100
      • Recruiting
      • Ringsted Sygehus
    • Roskilde, Region Sjælland, Denmark, 4000
      • Recruiting
      • University Hospital of Region Zealand, Roskilde
    • Slagelse, Region Sjælland, Denmark, 4200
      • Recruiting
      • Slagelse Sygehus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment with Hydrocortisone.; This arm will recieve a dose of 200 mg of Hydrocortisone intravenously once daily for five days.	Drug: Hydrocortisone; ATC-code: H02AB09. Can be changed to 50 mg x 4 daily orally if appropriate.
Active Comparator: Treatment with Methylprednisolone; This arm will recieve a dose of 40 mg of Methylprednisolone intravenously once daily for five days.	Drug: Methylprednisolone (drug); ATC code: H02AB06. Can be changed to Prednisolone 50 mg orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Readmission for COPD exacerbation or death from all causes	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality		90 days
Readmission for COPD exacerbation		90 days
All-cause infections	Defined as a new prescription of antibacterial medication.	90 days
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	Measured at day 3 and day 7	7 days
Days alive and out of hospital		14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procalcitonin (PCT) at baseline	Procalcitonin (PCT) at baseline, day 3 and day 7. If still at hospital.	7 days
C-reactive protein (CRP) at baseline	C-reactive protein (CRP) at baseline, day 3 and day 7. If still in hospital.	7 days
Blood eosinophil count (EOS) at baseline	Blood eosinophil count (EOS) at baseline, day 3 and day 7. If still in hospital.	7 days

Collaborators and Investigators

• Sponsor: Copenhagen Respiratory Research
• Investigators: Study Director: Jens-Ulrik Stæhr Jensen, MD, PHD, COP:RESP

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): November 1, 2030

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 24, 2025

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienetriols; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; 17-Hydroxycorticosteroids; Prednisolone; Methylprednisolone; Hydrocortisone; Pharmaceutical Preparations
• Other Study ID Numbers: MineraloCOP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This has not yet been decided.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No