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

ConditionChronic Obstructive Pulmonary Disease (COPD)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorCopenhagen Respiratory Research

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥40 years

Chronic obstructive pulmonary disease with acute exacerbation, unspecified: ICDJ44

Disqualifiers

All diagnoses that would merit treatment with a specific corticosteroid

Pregnant or breastfeeding women

Active tuberculosis or invasive fungal infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: Treatment with Hydrocortisone.Active comparator 1 intervention
Group B: Treatment with MethylprednisoloneActive comparator 1 intervention

Trial outcomes

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

Defined as a new prescription of antibacterial medication.

Time frame
90 days

Other outcomes

1

Procalcitonin (PCT) at baseline

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

Time frame
7 days
2

C-reactive protein (CRP) at baseline

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

Time frame
7 days
3

Blood eosinophil count (EOS) at baseline

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

Time frame
7 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Copenhagen Respiratory Research

Lead sponsor

Source ClinicalTrials.gov
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