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

NCT06892210 | Recruiting Phase 4 DMC

• 1 other identifier: MineraloCOP
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 14

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• Readmission for COPD exacerbation or death from all causes

  30 days

Secondary Outcomes (9)

• Days alive and out of hospital

  14 days

• Mortality

  90 days

• Readmission for COPD exacerbation

  90 days

• All-cause infections

  90 days

• Need for mechanical ventilation

  30 days

Other Outcomes (3)

• Procalcitonin (PCT) at baseline

  7 days

• C-reactive protein (CRP) at baseline

  7 days

• Blood eosinophil count (EOS) at baseline

  7 days

Study Arms (2)

Treatment with Hydrocortisone.

ACTIVE COMPARATOR

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

Drug: Hydrocortisone

Treatment with Methylprednisolone

ACTIVE COMPARATOR

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

Drug: Methylprednisolone (drug)

Interventions

Methylprednisolone (drug) DRUG

ATC code: H02AB06. Can be changed to Prednisolone 50 mg orally.

Treatment with Methylprednisolone

Hydrocortisone DRUG

ATC-code: H02AB09. Can be changed to 50 mg x 4 daily orally if appropriate.

Treatment with Hydrocortisone.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Copenhagen Respiratory Research: lead

Study Sites (14)

Bornholm Hospital

Rønne, Bornholm, 3700, Denmark

RECRUITING

Amager Hospital

Copenhagen, Copenhagen City, 2300, Denmark

RECRUITING

Bispebjerg Hospital

Copenhagen, Copenhagen City, 2400, Denmark

RECRUITING

Frederiksberg Hospital

Frederiksberg, Copenhagen City, 2000, Denmark

RECRUITING

Gentofte Hospital

Hellerup, Copenhagen City, 2900, Denmark

RECRUITING

Herlev Hospital

Herlev, Copnhagen Surroundings, 2730, Denmark

RECRUITING

Hvidovre Hospital

Hvidovre, Copnhagen Surroundings, 2650, Denmark

RECRUITING

Nordsjællands Hospital

Hillerød, North Zealand, 3400, Denmark

RECRUITING

Holbæk Sygehus

Holbæk, Region Sjælland, 4300, Denmark

RECRUITING

University Hospital of Region Zealand, Køge

Køge, Region Sjælland, 4600, Denmark

RECRUITING

Næstved Sygehus

Næstved, Region Sjælland, 4700, Denmark

RECRUITING

Ringsted Sygehus

Ringsted, Region Sjælland, 4100, Denmark

RECRUITING

University Hospital of Region Zealand, Roskilde

Roskilde, Region Sjælland, 4000, Denmark

RECRUITING

Slagelse Sygehus

Slagelse, Region Sjælland, 4200, Denmark

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Methylprednisolone; Pharmaceutical Preparations; Hydrocortisone

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnenediones; Pregnenes; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Jens-Ulrik Stæhr Jensen, MD, PHD

  COP:RESP

  STUDY DIRECTOR

Central Study Contacts

Jens-Ulrik Stæhr Jensen, MD, PHD

CONTACT

38673057; jens.ulrik.jensen@regionh.dk

Pradeesh Sivapalan, MD, PHD

CONTACT

29880601; pradeesh.sivapalan.02@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: The study is a cluster randomized controlled trial. It consists of two arms, in which patients will be randomized to receive treatment with either Hydrocortisone or Methylprednisolone.

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 24, 2025
• Study Start: March 10, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): November 1, 2030
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

DK (14)