This study explores whether patients hospitalized with chronic obstructive pulmonary disease (COPD) exacerbation may have fewer days with prednisolone and with the same treatment effect by controlling the treatment by daily measurements of eosinophils.
The most commonly used treatment for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is a 5-day treatment with corticosteroids in moderate-high dose. Some patients receive repeated treatments, although it has been shown that corticosteroids only have temporary beneficial effects and no effect in relation to serious incidents or mortality. It has been found that the higher accumulated prednisolone dose disables patients due to serious side effects, including pneumonia, dysregulated diabetes, bone fracture in the context of osteoporosis, mental disorder and adrenal insufficiency etc. However, the extent of the side effects is unknown. Recent research has shown that it is presumably only a small subset of COPD patients who benefit from corticosteroid therapy. This group can be identified by the biomarker "blood-eosinophils" as already measured on most AECOPD patients during hospitalization. This is a randomized, controlled, multi-center, non-Inferiority trial evaluating the effect of eosinophil guided corticosteroid therapy to patients with AECOPD. The aim of the study is to investigate whether the accumulated dose corticosteroid treatment during admissions for AECOPD can be reduced, including the presumed side effects, while (still) remaining the optimal treatment effect.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
318
Bispebjerg University Hospital
Copenhagen, Denmark
Hvidovre University Hospital
Copenhagen, Denmark
North Zealand Hospital
Copenhagen, Denmark
Gentofte University Hospital
Hellerup, Denmark
Days alive and out of hospital within 14 days after recruitment
Time frame: 14 days from recruitment
Treatment failure (Recurrence of AECOPD resulting in emergency room visits, hospitalization or need to intensify pharmacological treatment within 30 days)
Time frame: 30 days
Change in lung function (ΔFEV1) on day 3, after 1 month and 3 month
Time frame: 90 days
Mortality
Time frame: 360 days
Infection requiring antibiotic treatment within 180 days after the index of AECOPD
Time frame: 180 days
The period between index AECOPD and the next AECOPD exacerbation
1. Readmission with AECOPD or death 2. Time to readmission with AECOPD or death
Time frame: 90 days
Cumulative corticosteroid dose at 1 and 3 month follow-up
1. Proportions of patients using corticosteroids during hospitalization (day 1 to day 5) between treatment arms 2. Mean total cumulative dose from recruitment to 3-month follow-up
Time frame: 90 days
Hyperglycemia during admission
Time frame: 14 days
Changes in PTH and Vitamin D status between hospitalization and 3-month follow-up
Time frame: 90 days
Change in bone marker levels (Serum P1NP, Serum CTX)
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Time frame: 90 days
Dyspepsia or ulcer complications (gastrointestinal bleeding)
Time frame: 90 days
New onset or worsening of diabetes mellitus
Time frame: 30 days
Increase in body mass index between hospitalization, at 30 days and 3-month follow-up
Time frame: 90 days
The impact of COPD (cough, sputum, dysnea, chest tightsenes etc) on health status (COPD Assessment Test) between hospitalization, at 30 days and 3-month follow-up
Time frame: 90 days
Changes in level of dyspnea using the Medical Research Council (MRC) Dyspnoea Scale between hospitalization, at 30 days and 3-month follow-up
Time frame: 90 days
Osteoporotic fractures
Time frame: 360 days