Corticosteroid Reduction in COPD

COPD Clinical Trial

— Cortico-cop  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02857842
• Other study ID #: Protocol_CORTICO-COP_PSJUJ
• Status: Completed
• Phase: Phase 4
• Start date: August 2016
• Est. completion date: January 2019

Study information

• Verified date: February 2019
• Source: Chronic Obstructive Pulmonary Disease Trial Network, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: January 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Prednisolone

Locations

Country	Name	City	State
Denmark	Bispebjerg University Hospital	Copenhagen
Denmark	Hvidovre University Hospital	Copenhagen
Denmark	North Zealand Hospital	Copenhagen
Denmark	Gentofte University Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days alive and out of hospital within 14 days after recruitment		14 days from recruitment
Secondary	Treatment failure (Recurrence of AECOPD resulting in emergency room visits, hospitalization or need to intensify pharmacological treatment within 30 days)		30 days
Secondary	Change in lung function (?FEV1) on day 3, after 1 month and 3 month		90 days
Secondary	Mortality		360 days
Secondary	Infection requiring antibiotic treatment within 180 days after the index of AECOPD		180 days
Secondary	The period between index AECOPD and the next AECOPD exacerbation	Readmission with AECOPD or death; Time to readmission with AECOPD or death	90 days
Secondary	Cumulative corticosteroid dose at 1 and 3 month follow-up	Proportions of patients using corticosteroids during hospitalization (day 1 to day 5) between treatment arms; Mean total cumulative dose from recruitment to 3-month follow-up	90 days
Secondary	Hyperglycemia during admission		14 days
Secondary	Changes in PTH and Vitamin D status between hospitalization and 3-month follow-up		90 days
Secondary	Change in bone marker levels (Serum P1NP, Serum CTX)		90 days
Secondary	Dyspepsia or ulcer complications (gastrointestinal bleeding)		90 days
Secondary	New onset or worsening of diabetes mellitus		30 days
Secondary	Increase in body mass index between hospitalization, at 30 days and 3-month follow-up		90 days
Secondary	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		90 days
Secondary	Changes in level of dyspnea using the Medical Research Council (MRC) Dyspnoea Scale between hospitalization, at 30 days and 3-month follow-up		90 days
Secondary	Osteoporotic fractures		360 days

External Links

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