Comparing Hydrocortisone and Prednisolone for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 2,000
- Locations
- 14
- Primary Endpoint
- Readmission for COPD exacerbation or death from all causes
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment with Hydrocortisone.
This arm will recieve a dose of 200 mg of Hydrocortisone intravenously once daily for five days.
Intervention: Hydrocortisone (Drug)
Treatment with Methylprednisolone
This arm will recieve a dose of 40 mg of Methylprednisolone intravenously once daily for five days.
Intervention: Methylprednisolone (drug) (Drug)
Outcomes
Primary Outcomes
Readmission for COPD exacerbation or death from all causes
Time Frame: 30 days
Secondary Outcomes
- Readmission for COPD exacerbation(90 days)
- Daily amount of insulin administered to the patient by day 7 or discharge from hospital(7 days)
- Gastrointestinal bleeding(30 days)
- Days alive and out of hospital(14 days)
- Mortality(90 days)
- All-cause infections(90 days)
- Need for mechanical ventilation(30 days)
- New onset infections(30 days)
- Blood glucose levels(7 days)