The effect of reduced corticosteroid therapy in patients with acute exacerbation of COPD

Phase 1

• Conditions: 1) Whether a reduction of the dose systemic corticosteroids (SC) therapy in patients with acute exacerbation of COPD(AE-COPD) - compared with AE-COPD patients in the standard treatment- leading to non-inferiority 2)Whether there is a difference in treatment response in AE-COPD patients with eosinophilic airway inflammation compared to AE-COPD patients with non-eosinophilic airway inflammation 3) whether a lower accumulated dose SC may be associated with fewer corticosteroid adverse events; MedDRA version: 20.0 Level: LLT Classification code 10010953 Term: COPD exacerbation System Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-003441-26-DK
• Lead Sponsor: Chronic Obstructive Pulmonary Disease Trial Network (COP:TRIN)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-14
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 320

Inclusion Criteria

1) Patients hospitalized with COPD exacerbation
2) Age = 40 years
3) Spirometry-verified COPD (defined as FEV1 / FVC = 70%)
4) GOLD class C or D
5) Inclusion within 24 hours after admission
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 290

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose is to examine whether we can reduce the accumulated corticosteroid therapy to the individual COPD patient with the aim of reducing the number of corticosteroid-related adverse events.;<br> Secondary Objective: Is there a difference in treatment response in AE-COPD patients with<br> eosinophilic airway inflammation and AE-COPD patients with predominantly non-eosinophilic airway inflammation<br> ;Primary end point(s): 1) Days alive and out of hospital within 14 days after recruitment;Timepoint(s) of evaluation of this end point: 14 days