Comparing Hydrocortisone and Prednisolone for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methylprednisolone (drug), Hydrocortisone.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease (COPD). Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Methylprednisolone (drug)
ATC code: H02AB06. Can be changed to Prednisolone 50 mg orally. - Drug Hydrocortisone
ATC-code: H02AB09. Can be changed to 50 mg x 4 daily orally if appropriate.
Primary outcome measures
- Readmission for COPD exacerbation or death from all causes [Time frame: 30 days]
Secondary outcome measures (9)
- Days alive and out of hospital [Time frame: 14 days]
- Mortality [Time frame: 90 days]
- Readmission for COPD exacerbation [Time frame: 90 days]
- All-cause infections [Time frame: 90 days]
- Need for mechanical ventilation [Time frame: 30 days]
- New onset infections [Time frame: 30 days]
- Daily amount of insulin administered to the patient by day 7 or discharge from hospital [Time frame: 7 days]
- Gastrointestinal bleeding [Time frame: 30 days]
- Blood glucose levels [Time frame: 7 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Denmark · 14 centers
- Bornholm Hospital — Rønne
- Amager Hospital — Copenhagen
- Bispebjerg Hospital — Copenhagen
- Frederiksberg Hospital — Frederiksberg
- Gentofte Hospital — Hellerup
- Herlev Hospital — Herlev
- Hvidovre Hospital — Hvidovre
- Nordsjællands Hospital — Hillerød
- … and 6 more centers
Identifiers
NCT: NCT06892210 · MineraloCOP