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NCT Number: NCT06892210

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.

Recruiting

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bornholm Hospital, Rønne, Bornholm, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylprednisolone (drug)

Drug

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

Hydrocortisone

Drug

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

Primary outcomes

  1. Readmission for COPD exacerbation or death from all causes

    Time frame: 30 days

Secondary outcomes

  1. Days alive and out of hospital

    Time frame: 14 days

  2. Mortality

    Time frame: 90 days

  3. Readmission for COPD exacerbation

    Time frame: 90 days

  4. All-cause infections

    Time frame: 90 days

    Defined as a new prescription of antibacterial medication.

  5. Need for mechanical ventilation

    Time frame: 30 days

  6. New onset infections

    Time frame: 30 days

  7. Daily amount of insulin administered to the patient by day 7 or discharge from hospital

    Time frame: 7 days

  8. Gastrointestinal bleeding

    Time frame: 30 days

  9. Blood glucose levels

    Time frame: 7 days

    Measured at day 3 and day 7

Other outcomes

  1. Procalcitonin (PCT) at baseline

    Time frame: 7 days

    Procalcitonin (PCT) at baseline, day 3 and day 7. If still at hospital.

  2. C-reactive protein (CRP) at baseline

    Time frame: 7 days

    C-reactive protein (CRP) at baseline, day 3 and day 7. If still in hospital.

  3. Blood eosinophil count (EOS) at baseline

    Time frame: 7 days

    Blood eosinophil count (EOS) at baseline, day 3 and day 7. If still in hospital.

Study contacts

Contact information is provided by the study sponsor or research team.

Jens-Ulrik Stæhr Jensen, MD, PHD

CONTACT

[email protected]

38673057 ext. +45

Pradeesh Sivapalan, MD, PHD

CONTACT

[email protected]

29880601 ext. +45

Sponsors and collaborators

Lead sponsor

Copenhagen Respiratory Research

Network

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Mar 24, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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