Corticosteroid Reduction in COPD (Cortico-cop)

Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Status and phase: Completed; Phase 4

Conditions: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; COPD; Glucocorticoids; Blood Eosinophil Count

Treatments: Drug: Prednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT02857842

Protocol_CORTICO-COP_PSJUJ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 318 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients hospitalized with AECOPD
• Age ≥ 40 years
• Spirometry-verified COPD (defined as FEV1 / FVC ≤ 70%)
• Chronic Obstructive Lung Disease (GOLD) class C or D
• Inclusion within 24 hours after admission

Exclusion criteria

• Known with a diagnosis of asthma
• Life expectancy less than 30 days
• Serious exacerbation requiring invasive ventilation or admission to ICU
• Allergy to systemic corticosteroids
• Severe mental illness, which is not controlled by medication
• People who are detained under the act on the use of coercion in psychiatry
• Severe language problems or inability to provide written informed consent
• Pregnancy and lactation
• Systemic fungal infections

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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318 participants in 2 patient groups

Blood eosinophil guided prednisolone treatment

Experimental group

Description:

Intravenous Solu-Medrol 80 mg, followed by prednisolone tablet 37.5 mg daily (maximum of 5 days in all) if the eosinophil count in the blood ≥ 0.3 x 10E9/L. Eosinophil count in the blood \<0.3 x 10E9/L results in no treatment with prednisolone. If the patient is discharged during the treatment period, given treatment from the last measured eosinophil count the remaining days.

Treatment:

Drug: Prednisolone

Standard of care

Active Comparator group

Description:

Intravenous Solu-Medrol 80 mg on the first day followed by 37.5 mg of prednisolone tablets (1 x 25 mg plus 1 x 12.5 mg) daily for 5 days

Treatment:

Drug: Prednisolone