Corticosteroid Reduction in COPD

Phase 4

Completed

• Conditions: Lung Diseases, Obstructive; Blood Eosinophil Count; COPD; Glucocorticoids; Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Prednisolone

• Registration Number: NCT02857842
• Lead Sponsor: Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Brief 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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-05
• Primary Completion: 2018-09
• Study Completion: 2019-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 318

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	Prednisolone	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
Blood eosinophil guided prednisolone treatment	Prednisolone	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.

Primary Outcome Measures

Name	Time	Method
Days alive and out of hospital within 14 days after recruitment	14 days from recruitment

Secondary Outcome Measures

Name	Time	Method
Treatment failure (Recurrence of AECOPD resulting in emergency room visits, hospitalization or need to intensify pharmacological treatment within 30 days)	30 days
Change in lung function (ΔFEV1) on day 3, after 1 month and 3 month	90 days
Mortality	360 days
Cumulative corticosteroid dose at 1 and 3 month follow-up	90 days	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
Changes in PTH and Vitamin D status between hospitalization and 3-month follow-up	90 days
Infection requiring antibiotic treatment within 180 days after the index of AECOPD	180 days
The period between index AECOPD and the next AECOPD exacerbation	90 days	1. Readmission with AECOPD or death; 2. Time to readmission with AECOPD or death
Hyperglycemia during admission	14 days
Change in bone marker levels (Serum P1NP, Serum CTX)	90 days
New onset or worsening of diabetes mellitus	30 days
Increase in body mass index between hospitalization, at 30 days and 3-month follow-up	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	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	90 days
Osteoporotic fractures	360 days
Dyspepsia or ulcer complications (gastrointestinal bleeding)	90 days

Trial Locations

Locations (4)

Bispebjerg University Hospital; 🇩🇰 Copenhagen, Denmark

North Zealand Hospital; 🇩🇰 Copenhagen, Denmark

Gentofte University Hospital; 🇩🇰 Hellerup, Denmark

Hvidovre University Hospital; 🇩🇰 Copenhagen, Denmark