Chronic Obstructive Pulmonary Disease (COPD)
Conditions
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.
Interventions
ATC code: H02AB06. Can be changed to Prednisolone 50 mg orally.
DRUGHydrocortisone
ATC-code: H02AB09. Can be changed to 50 mg x 4 daily orally if appropriate.
Sponsors
Copenhagen Respiratory Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
The study is a cluster randomized controlled trial. It consists of two arms, in which patients will be randomized to receive treatment with either Hydrocortisone or Methylprednisolone.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Readmission for COPD exacerbation or death from all causes | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days alive and out of hospital | 14 days | — |
| Mortality | 90 days | — |
| Readmission for COPD exacerbation | 90 days | — |
| All-cause infections | 90 days | Defined as a new prescription of antibacterial medication. |
| Need for mechanical ventilation | 30 days | — |
| New onset infections | 30 days | — |
| Daily amount of insulin administered to the patient by day 7 or discharge from hospital | 7 days | — |
| Gastrointestinal bleeding | 30 days | — |
| Blood glucose levels | 7 days | Measured at day 3 and day 7 |
Countries
Denmark
Contacts
CONTACTJens-Ulrik Stæhr Jensen, MD, PHD
CONTACTPradeesh Sivapalan, MD, PHD
STUDY_DIRECTORJens-Ulrik Stæhr Jensen, MD, PHD
COP:RESP
Outcome results
None listed