NCT02857842

Corticosteroid Reduction in COPD

The Effect of Reduced Corticosteroid Therapy in Patients With Acute Exacerbation of COPD

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 318 (actual)
• Sponsor: Chronic Obstructive Pulmonary Disease Trial Network, Denmark · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lung Diseases, Obstructive
• Blood Eosinophil Count
• Glucocorticoids
• COPD
• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	Prednisolone

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-09-01
• Completion: 2019-01-01
• First posted: 2016-08-05
• Last updated: 2019-02-08

Locations

4 sites across 1 country: Denmark