Hydrocortisone versus Prednisolone for COPD flare-ups

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

This test compares hydrocortisone and prednisolone to see which works better and causes fewer side effects in people 40 and older who have a COPD exacerbation.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2000 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Copenhagen Respiratory Research (Research network)
• Locations: 14 sites (Rønne, Bornholm and 13 other locations)
• Trial ID: NCT06892210 on ClinicalTrials.gov

What this trial studies

This is a cluster-randomized trial that assigns participating hospitals or units to treat patients with either hydrocortisone or prednisolone for acute COPD exacerbations. Adults aged 40 and older presenting with an acute exacerbation of COPD are enrolled and receive the assigned systemic corticosteroid according to local protocols. The primary outcome is readmission for COPD exacerbation or all-cause mortality within 30 days, and safety outcomes include treatment-related side effects. Key exclusions include conditions that require a specific corticosteroid, pregnancy or breastfeeding, and active tuberculosis or invasive fungal infection.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 or older with diagnosed COPD presenting with an acute exacerbation who do not have contraindications to systemic corticosteroids.

Not a fit: Patients who require a particular corticosteroid for another diagnosis, who are pregnant or breastfeeding, or who have active tuberculosis or invasive fungal infection are unlikely to benefit from or be eligible for this comparison.

Why it matters

Potential benefit: If successful, the trial could identify which corticosteroid reduces 30-day readmissions and deaths or has a better side-effect profile for COPD exacerbations.

How similar studies have performed: Systemic corticosteroids are known to improve outcomes in COPD exacerbations, but direct head-to-head comparisons between hydrocortisone and prednisolone are limited, so this specific comparison is relatively novel.

Eligibility criteria

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

Where this trial is running

Rønne, Bornholm and 13 other locations

• Bornholm Hospital — Rønne, Bornholm, Denmark (Recruiting)
• Amager Hospital — Copenhagen, Copenhagen City, Denmark (Recruiting)
• Bispebjerg Hospital — Copenhagen, Copenhagen City, Denmark (Recruiting)
• Frederiksberg Hospital — Frederiksberg, Copenhagen City, Denmark (Recruiting)
• Gentofte Hospital — Hellerup, Copenhagen City, Denmark (Recruiting)
• Herlev Hospital — Herlev, Copnhagen Surroundings, Denmark (Recruiting)
• Hvidovre Hospital — Hvidovre, Copnhagen Surroundings, Denmark (Recruiting)
• Nordsjællands Hospital — Hillerød, North Zealand, Denmark (Recruiting)
• Holbæk Sygehus — Holbæk, Region Sjælland, Denmark (Recruiting)
• University Hospital of Region Zealand, Køge — Køge, Region Sjælland, Denmark (Recruiting)
• Næstved Sygehus — Næstved, Region Sjælland, Denmark (Recruiting)
• Ringsted Sygehus — Ringsted, Region Sjælland, Denmark (Recruiting)
• University Hospital of Region Zealand, Roskilde — Roskilde, Region Sjælland, Denmark (Recruiting)
• Slagelse Sygehus — Slagelse, Region Sjælland, Denmark (Recruiting)

Study contacts

• Study coordinator: Jens-Ulrik Stæhr Jensen, MD, PHD

Conditions Chronic Obstructive Pulmonary Disease